GMP Compliant Facilities as at July 2021

S/NSiteSite NameAddressCountryLicense NumberPayment DateReceipt NumberInspection DateExpiration DateProduction Line CategoryLines InspectedLines PassedLines FailedGMP Team LeaderValidity of ceritificate
1142/GMP/2018 DRA. Menarini Manufacturing Logistics and Services S.R.LVia Campo di Pile- 67100 L’aquila (AQ) ItalyItaly1/6/2017RT782878/6/20188/6/2021Non Beta LactamTablets (Coated and Uncoated)Tablets (Coated and Uncoated)NoneDenis Mwesigwa8/6/2021
2010/GMP/2019 DRA. Nattermann and Cie. GmbHNattermannallee 1, 50829 Koln, GermanyGermany11/29/2017RT847671/8/20191/8/2022Non-Beta LactamNon-Beta Lactam: Large Volume Parenterals Small Volume Parenterals Tablets Veterinary Premixes Oral Powders and Granules Oral LiquidsNon-Beta Lactam: Large Volume Parenterals Small Volume Parenterals Tablets Veterinary Premixes Oral Powders and Granules Oral LiquidsNoneKaleebu Frank1/8/2022
3IRF/F/030/02/2019 084/GMP/2019 GMP Cert No.Abaris Healthcare Pvt LimitedPlot no: 1407/11, Village: rajpur, Taluka: kadi, dist.: mehsana -382 740, Gujarat, indiaIndiaG/28D/LVP/72/28/2018RT9371511/30/2018Non-beta Lactam Blow-Fill-Seal (BFS)Non-beta Lactam Blow-Fill-Seal (BFS): • Large Volume Parenteral Solutions (BFS) terminally sterilized • Small volume parenteral solutions 100ml (BFS) terminally sterilizedNon-beta Lactam Blow-Fill-Seal (BFS): • Large Volume Parenteral Solutions (BFS) terminally sterilized • Small volume parenteral solutions 100ml (BFS) terminally sterilizedNoneMwonda Zaid11/30/2021
4IRF/F/051/03/2019 GMP Cert No. 062/GMP/2019Abbott Biologicals B.V.Veerweg 12, 8121 AA Olst, The Netherlands.NetherlandsAuthorization No. 108926 F, granted on April 1st, 2008; changed on January 23, 20188/23/2017RT6893411/30/2018Non-Beta LactamNon-Beta Lactam: • Influenza virus vaccine in pre-filled syringes • Hormonal tablets, coated • Oral liquidsNon-Beta Lactam: • Influenza virus vaccine in pre-filled syringes • Hormonal tablets, coated • Oral liquidsNoneSsali Peter11/30/2021
5202/GMP/2018Aeropharm GmbHFrancois – Mitterand – Allee 1, 07407 Rudolstadt, GermanyGermany6/11/2018RT9588012/13/2018Non-Beta LactamNon-Beta Lactam Pressurised Preparations (Metered Dose Inhalers)Non-Beta Lactam Pressurised Preparations (Metered Dose Inhalers)NoneKaleebu Frank12/13/2021
6IRF/F/388/09/2018 R12 178/GMP/2018 GMP Cert NoAfricure Pharmaceuticals India Pvt. LimitedPlot No 9 – 12, Dewan & Sons Industrial Area, Veoor, Palghar – 401404 Palghar District Maharashtra State, IndiaIndiaForm 25: MH/102298 and Form 28: MH/102299 valid till 26/07/2022 issued by Food and Drug Administration of Maharashtra State12/23/2016RT780087/27/20187/27/2021Non Beta LactamNon Beta Lactam • Tablets (coated and uncoated) • Hard Gelatin CapsulesNon Beta Lactam • Tablets (coated and uncoated) • Hard Gelatin CapsulesNoneNasser Lubowa7/27/2021
7IRF/F/073/05/2019 182/GMP/2019 Cert No.Ajanta Pharma LimitedPlot No.Z/103/A,Dahej SEZ Part II,District: Bharuch, Gujarat-392130, IndiaIndia/25/2080 form 25 G/28/1505 form 28 issued by Gujarat State Foods and Drugs Administration valid up to 23/09/202112/16/2016RT776961/25/20191/25/2022Non ?-lactamNon ?-lactam: • Tablets (Coated & Uncoated) • Hard gelatin capsules • Powder for oral suspension • Oral jellyNon ?-lactam: • Tablets (Coated & Uncoated) • Hard gelatin capsules • Powder for oral suspension • Oral jellyNoneWilberforce Kwiringira1/25/2022
8IRF/F/421/10/2018 001/GMP/2019 GMP Cert No.Ajanta Pharma Limited (Chikalthana Unit)31-O, MIDC Area, Chikalthana, Aurangabad-431210, Dist: Aurangabad, Maharashtra state.India611 on form 25 and 480 on form 283/21/2018RT943729/13/20189/13/2021Non beta lactamNon beta lactam: • Oral liquidsNon beta lactam: • Oral liquidsNoneAtumanya Amos9/13/2021
9IRF/F/392/09/2018 R12 180/GMP/2018 GMP Cert NoAlivira Animal Health LtdA-68, MIDC Industrial Area, Additional Ambernath; Thane, Maharashtra-IndiaIndiaForm 28 MH/101174 VALID TILL -12/01/2020 Form 29 MH/101175 VALID TILL -12/01/20204/12/2017RT815898/14/20188/14/2021Non Beta Lactam (veterinary use)Non Beta Lactam (veterinary use) • SVP (Granules for injection) • Liquids (Oral suspensions)Non Beta Lactam (veterinary use) • SVP (Granules for injection) • Liquids (Oral suspensions)NoneMwesigwa Denis8/14/2021
10046/GMP/2019 DRAndersonBrecon (UK) LimitedUnits 2-7, Wye Valley Business Park,Brecon Road, Hay-on-Wye, Hereford, HR3 5PG, United Kingdom.United Kingdom11/14/2016RT759212/20/20192/20/2022Non-Beta LactamNon-Beta Lactam: Primary and Secondary PackagingNon-Beta Lactam: Primary and Secondary PackagingNone2/20/2022
11IRF/F/359/08/2018 R12 189/GMP/2018 GM Cert NoArab Drug Company for pharmaceuticals & chemical industries5 EL Massanei Street AL Amireya – Cairo- EgyptEgyptFM-LPM-027/2/2015RT631537/12/20187/12/2021Non ?-lactamNon ?-lactam • Aerosol InhalerNon ?-lactam • Aerosol InhalerNoneKenneth Kiiza7/12/2021
12IRF/F/083/05/2019 172/GMP/2019 Cert No.Arab Veterinary Industrial Company AvicoAlquds St- Naur, Amman Jordan, P.O Box 150906Jordan119 Valid from 15/01/2019 to 15/01/20201/29/2018RT920974/16/20194/16/2022Non-Beta Lactam (Veterinary)Non-Beta Lactam (Veterinary): • Small volume liquids (aseptically filled) • Large Volume Liquids (aseptically filled) • Liquid for internal use • Powders for Oral SuspensionsNon-Beta Lactam (Veterinary): • Small volume liquids (aseptically filled) • Large Volume Liquids (aseptically filled) • Liquid for internal use • Powders for Oral SuspensionsNoneKaleebu Frank4/16/2022
13164/GMP/2018 DRAstra Zeneca Pharmaceuticals Limited587 Old Baltimore Pike Newark De 19702 United States of AmericaUnited States Of America10/24/2016RT7525710/31/201810/31/2021Non-Beta LactamNon-Beta Lactam TabletsNon-Beta Lactam TabletsNoneKaleebu Frank10/31/2021
14196/GMP/2018 DRAstraZeneca Mt Vernon Operations4601 Highway 62 East Mt Vernon IN 47620United States Of America9/21/2018RT10166511/28/2018Non-Beta LactamNon-Beta Lactam TabletsNon-Beta Lactam TabletsNoneKaleebu Frank11/28/2021
15051/GMP/2019 DRAstraZeneca Sweden OperationsAstraZeneca Sweden Operations, SE-151 85 Sodertalje Sweden.Sweden9/21/2018RT1016643/12/20193/12/2022Non-Beta LactamNon-Beta Lactam: Tablets SVP Lyophilisates SVP Pressurised Inhalers Nebulising SuspensionsNon-Beta Lactam: Tablets SVP Lyophilisates SVP Pressurised Inhalers Nebulising SuspensionsNone3/12/2022
16086/GMP/2019 DRAthlone Pharmaceuticals LimitedBallymurray, Co. Roscommon - IrelandIreland4/26/2018RT955496/5/20196/5/2022PenicillinPenicillin: Hard gelatin capsules Oral LiquidsPenicillin: Hard gelatin capsules Oral LiquidsNoneKaleebu Frank6/5/2022
17IRF/F/036/02/2019 042/GMP/2019 GMP Cert No.Aurobindo Pharma LimitedUnit VII (SEZ), Plot No.S1, Green Industrial Park, Polepally (V) Jedcheria (M), Mahaboob Nagar Hyderabad, 509 302 A.P IndiaIndia22/MN/AP/2009/F/R valid up to 28.04.201910/20/2017RT8478111/20/201811/20/2021Non-beta LactamNon-beta Lactam: • Tablets ( coated and un coated) • Hard Gelatin Capsule • Soft Gelatin CapsuleNon-beta Lactam: • Tablets ( coated and un coated) • Hard Gelatin Capsule • Soft Gelatin CapsuleNoneAnnet Ssekindu11/20/2021
18IRF/F/403/09/2018 R12 152/GMP/2018 GMP CERT NoAurobindo Pharma Limited, Unit-XPlot No.16, APIIC Multiproduct SEZ Telangana District- 509302 Menakuru, Naidupet Mandal, Nellore District, Pin code: 524421, Andhra Pradesh. IndiaIndia04/NLR/AP/2016/F/G dated 29/02/2016 valid up to 28/02/2021 and issued by Government of Andra Pradesh Drugs Control Administration.11/7/2017RT892807/31/20187/31/2021Non-beta lactamNon-beta lactam • Hard gelatin Capsules • Tablets • Oral liquids for human useNon-beta lactam • Hard gelatin Capsules • Tablets • Oral liquids for human useNoneZaid Mwonda7/31/2021
19IRF/F/379/09/2018 R12 145/GMP/2018 GMP CERT NoAurobindo Unit XVPlot No. 17 A, E. Bonangi (Village), Jawaharlal Nehru Pharma City, Parawada Mandal, Visakhapatnam Dist, Andhra Pradesh -531021 IndiaIndia14/VSP/AP/2015/F/G valid till 27/08/202011/8/2017RT892787/24/2018Non-Beta lactamNon-Beta lactam • Tablets (Uncoated, Film coated, Enteric coated) • Capsules (Hard gelatin)Non-Beta lactam • Tablets (Uncoated, Film coated, Enteric coated) • Capsules (Hard gelatin)NoneEtuko Daniel7/24/2021
20IRF/F/438/12/2018 165/GMP/2019 GMP CertAxa Parenterals LtdAxa Parenterals Ltd, Kishanpur Jamalpur Roorkee Dist Haridwar-247667 Uttarakhand, IndiaIndia15/UA/SC/P(LVP)/2007 on Form 28 and 78/UA/SC/P-2006, valid up to 05th February, 20212/28/2017RT80134/RT745919/21/20189/21/2021Non-Beta Lactam Blow-Fill-Seal (BFS)Non-Beta Lactam Blow-Fill-Seal (BFS): • Large Volume Parenteral Solutions • Small Volume Parenteral Solutions • Eye drops and respulesNon-Beta Lactam Blow-Fill-Seal (BFS): • Large Volume Parenteral Solutions • Small Volume Parenteral Solutions • Eye drops and respulesNoneSsali Peter9/21/2021
21066/GMP/2019 DRBalkanpharma-Dupnitsa AD3 Samokovsko Shosse Str., 2600 Dupnitsa - BulgariaBulgaria6/7/2017RT834914/1/20194/1/2022Non-Beta LactamNon-Beta Lactam: Tablets Hard Gelatin CapsulesNon-Beta Lactam: Tablets Hard Gelatin CapsulesNoneOnen Solomon L.4/1/2022
22IRF/F/330/05/2018 R10 GMP Cert No. 010/GMP/2020Bayer (Pty) Ltd Crop science division5th Avenue, Vorsterskroon Ext 3 Nigel. South AfricaSouth Africa1/25/2017RT72043/JV16/6814/12/20188/7/2021Non Beta-lactam• Liquid EctoparasiticidesNone Beta - Lactam: Liquid EctoparasiticidesNoneNambasa Victoria8/7/2021
23146/GMP/2018 DRBayer Healthcare Manufacturing S.R.LVia E. Schering, 21-20090 Segrate, Milano ItalyItaly12/14/2017RT906859/17/20189/17/2021Non Beta LactamCreams OintmentsCreams OintmentsNoneDenis Mwesigwa9/17/2021
24IRF/F/385/09/2018 R12 093/GMP/2019 Cert No.Bayer Korea, Banwol plant14, Neungan-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Korea 425100, Republic of South KoreaKorea, Republic of (South)008, first issued in 09/02/1966 with the latest update on 23/09/2016. The license is updated when the site undergoes a major change6/6/2017RT834168/10/20188/10/2021Non beta-lactam veterinaryNon beta-lactam veterinary • LVP solutions • SVP solutions. • Oral liquidsNon beta-lactam veterinary • LVP solutions • SVP solutions. • Oral liquidsNoneOnen Solomon L.8/10/2021
25194/GMP/2018 DRBerlin-Chemi AG (Andlershof site)Glienicker Weg, 125-D-12489 BerlinGermany9/21/2018RT10150411/30/2018Non-Beta LactamNon-Beta Lactam Tablets (Primary and Secondary Packaging, Quality Control Testing)Non-Beta Lactam Tablets (Primary and Secondary Packaging, Quality Control Testing)NoneKaleebu Frank11/30/2021
26195/GMP/2018 DRBerlin-Chemi AG, Site BitzTempelhofer Weg, 83-D-12347Germany9/21/2018RT10150411/30/2018Non-Beta LactamNon-Beta Lactam Tablets (Bulk manufacturing)Non-Beta Lactam Tablets (Bulk manufacturing)NoneKaleebu Frank11/30/2021
27IRF/F/053/03/2019 075/GMP/2019 GMP Cert No.Beta Drugs LimitedKharuni-Lodhimajra, Vil. Nandpur Baddi, Dist.-Solan, Himachal Pradesh, India.IndiaMB/09/749 (Form 28) and MNB/09/748 and MB/09/749 (Form 26), Valid to 26/10/20199/13/2018RT10131212/5/2018Non-beta lactam (Oncology)Non-beta lactam (Oncology) • Tablets (Coated and Uncoated) • Hard Gelatin Capsules • Small Volume Parenterals- Lyophilised Powders • Small Volume Parenterals-Solutions Aseptically filledNon-beta lactam (Oncology) • Tablets (Coated and Uncoated) • Hard Gelatin Capsules • Small Volume Parenterals- Lyophilised Powders • Small Volume Parenterals-Solutions Aseptically filledNoneNasser Lubowa12/5/2021
28IRF/F/435/12/2018 197/GMP/2018 GMP Cert No.Bioton S.ABioton S.A Macierzysz, Poznanska12 str 05-850 Ozarow Mazowiecki PolandPolandGIF-IW-400/0026-01-06/04/195/16 valid for three years7/4/2018RT9910210/20/2018Non-beta lactamNon-beta lactam: • Small Volume Parenteral (Insulin)Non-beta lactam: • Small Volume Parenteral (Insulin)NoneAmoreen Naluyima10/20/2021
29IRF/F/401/10/2018 R12 198/GMP/2018Blue Cross Laboratories Pvt LtdL-17, Verna Industrial Estate, Verna Goa- 403 722. IndiaIndiaForm 28 No. 395 valid 31/12/2021 Form 25 No. 271 valid 31/12/20227/21/2017RT860438/17/20188/17/2021Non beta-lactamNon beta-lactam • Oral liquids (suspensions and solutions). • Tablets (coated and uncoated). • Topical preparations (creams and gels)Non beta-lactam • Oral liquids (suspensions and solutions). • Tablets (coated and uncoated). • Topical preparations (creams and gels)NoneDenis Mwesigwa8/17/2021
30IRF/F/383/09/2018 R12 113/GMP/2019 Cert No.Botswana Vaccine Institute LtdPlot 6385/90, Lejara Road, Broadhurst Industrial GaboroneBotswana000123681A3/29/2017RT810998/24/20188/24/2021Non Beta lactam (Foot and Mouth Disease Vaccine)Non Beta lactam (Foot and Mouth Disease Vaccine) • Aftovax • AftovaxpurNon Beta lactam (Foot and Mouth Disease Vaccine) • Aftovax • AftovaxpurNoneKaleebu Frank8/24/2021
31IRF/F/062/04/2019 129/GMP/2019 Cert No.CCL Pharmaceuticals (Pvt) Limited62 Industrial Estate, Kot Lakhpat, Lahore. PakistanPakistanForm 2 no. 000052 Valid until 21/07/202010/18/2018RT10240512/7/201812/7/2021Non-beta lactam CephalosporinNBL: Tablet Hard gelatin capsules Oral liquid preparations Dry powder for oral suspension SVPs – Ampoules LVPs – Ampoules Cephalosporin: Tablets Dry powder for oral suspension Hard gelatin capsules Dry powder for injectionsNBL: Tablet Hard gelatin capsules Oral liquid preparations Dry powder for oral suspension SVPs – Ampoules LVPs – Ampoules Cephalosporin: Tablets Dry powder for oral suspension Hard gelatin capsules Dry powder for injectionsNoneDenis Mwesigwa12/7/2021
32IRF/F/006/01/2019 092/GMP/2019 Cert No.Celon Laboratories Private LimitedPlot No.2, Aleap Industrial Estate, Gajularamaram, Ranga Reddy District- 500 090 Telangana state, IndiaIndia14/RR/AP/2008/F/CC (Dt: 24/04/2008) & 25/HD/AP/2003/F/CC (Dt: 27/05/2003) on Form 28 & 25 respectively, valid up to 17th August, 20209/22/2017RT87825/RT8782411/16/201811/16/2021Non-Beta LactamNon-Beta Lactam • Tablets (coated and uncoated) • Hard Gelatin Capsules • SVP-Solution (Cytotoxic products) • SVP-Solution & LyophilizedNon-Beta Lactam • Tablets (coated and uncoated) • Hard Gelatin Capsules • SVP-Solution (Cytotoxic products) • SVP-Solution & LyophilizedNoneOkello Andrew11/16/2021
33IRF/F/354/08/2018 R12 127/GMP/2018Cenexi S.A.S52, rue Marcel et Jacques Gaucher 94120 Fontenay-sous-Bois- FranceFranceM16/3792/9/2018RT847747/24/2018Non-beta lactam:Non-beta lactam: • Tablets (coated and uncoated)Non-beta lactam: • Tablets (coated and uncoated)NoneKaleebu Frank7/24/2021
34140/GMP/2018 DRCeva Sante AnimaleZone Industrielle Tres Le Bois, BP 372,22603 Loudeac, Cedex- FranceFrance6/5/2018RT967599/7/20189/7/2021Beta Lactam Non Beta LactamBeta Lactam Tablet (coated and uncoated) Capsules Oral Powders Non Beta Lactam Oral Liquids Powders/Granules for Injection Reproductive Hormonal devices Tablets (coated and uncoated) Oral PowdersBeta Lactam Tablet (coated and uncoated) Capsules Oral Powders Non Beta Lactam Oral Liquids Powders/Granules for Injection Reproductive Hormonal devices Tablets (coated and uncoated) Oral PowdersNoneDenis Mwesigwa9/7/2021
35IRF/F/436/12/2018 074/GMP/2019 GMP Cert No.CEVA-PHYLAXIA Zrt1107 Budapest, Szallas u.5, HungaryHungaryMA-HU/04V/2009/M3 Valid up to 202111/28/2017RT9008410/30/2018Veterinary production line(s)Veterinary production line(s): • Inactivated viral and bacterial vaccines in SVP vials (liquids and freeze-dried) • Live attenuated viral and bacterial vaccines in SVP vials (Liquids and freeze-dried)Veterinary production line(s): • Inactivated viral and bacterial vaccines in SVP vials (liquids and freeze-dried) • Live attenuated viral and bacterial vaccines in SVP vials (Liquids and freeze-dried)NoneLukwago Mohammad10/30/2021
36IRF/F/054/03/2019 170/GMP/2019 Cert No.Cipla LimitedMIDC Patalganga, Dist. Raigad – 410220 Maharashtra. Plot No. A-33, A-2 & A-37/2/2 (Unit-I), A-42(Unit-II), IndiaIndiaUnit I- Form 25- 845 and Form 28- 707 Valid to 31/12/2022 Unit II- Form 25 KD-620 and Form 28 KD-435 Valid to 17/08/20211/16/2018RT9132411/30/201811/30/2021Non-?eta lactam ActivitiesNon-?eta lactam • Tablets (Coated and Uncoated) Activities • Manufacture of finished pharmaceutical productNon-?eta lactam • Tablets (Coated and Uncoated) Activities • Manufacture of finished pharmaceutical productNoneNasser Lubowa11/30/2021
37IRF/F/097/07/2019 (EAC) 045/GMP/2020 GMP Cert No.Cipla Quality Chemical Industries LimitedPlot 1-7, Ring Road, Luzira Industrial Park - UgandaUgandaLicense to operate a pharmaceutical manufacturer issued by NDA-Uganda valid up to 31st December, 2019 with premises number NDA/PRE/PMC/18478/17/2017RT867634/26/20194/26/2022Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDennis Mwesigwa4/26/2022
38IRF/F/059/03/2019 121/GMP/2019 Cert No.Concept Pharmaceuticals LimitedKishanpur Jamalpur Roorkee Dist Haridwar -247667 Uttarakhand, India.India35/UA/SC/P-2010 Form 28 & 34/UA/SC/P-2010 Form 25 valid up to 24th March 20201/18/2017RT7876911/30/201811/30/2021Non-Beta LactamNon-Beta Lactam • Small Volume Parenteral solutions (human and veterinary) • Tablets (coated and uncoated) • Hard gelatin CapsulesNon-Beta Lactam • Small Volume Parenteral solutions (human and veterinary) • Tablets (coated and uncoated) • Hard gelatin CapsulesNoneOnen Solomon L.11/30/2021
39IRF/F/021/02/2019 077/GMP/2019 GMP Cert No.Copmed Pharmaceuticals Pvt Ltd, Unit IIPlot No. 50, Gondpur Industrial Area Paonta Sahib, District Sirmour, Himachal Pradesh-173025, IndiaIndiaMB/06/479 valid up to 27/02/20221/29/2018RT92090, RT9209111/23/2018Beta LactamBeta Lactam • Cephalosporin (Tablets and Powders for oral suspension) • Penicillin (Tablets and Powders for oral suspension)Beta Lactam • Cephalosporin (Tablets and Powders for oral suspension) • Penicillin (Tablets and Powders for oral suspension)NoneAtumanya Amos11/23/2021
40081/GMP/2019 DRCorden Pharma SpAViale Dell’Industria 3, 20867, Caponago (MB) – UP1 (production unit 1) - ItalyItaly4/3/2019RT1088095/23/20195/23/2022Non-Beta LactamNon-Beta Lactam: SVP (Terminally sterilized)Non-Beta Lactam: SVP (Terminally sterilized)NoneKaleebu Frank5/23/2022
41IRF/F/056/03/2019 128/GMP/2019 Cert No.Corona Remedies Pvt. LimitedVillage: Jatoli, Post Office- Oachghat, Tehsil Solan, Dist. Solan (Himachal Pradesh) - 173223, IndiaIndiaMBN/07/613 (Form 25) and MBN/07/614 (Form 28), Granted on 01/08/2007 and Renewed from 01/08/2017 to 31/07/2022.8/1/2018RT99956,RT999012/11/201812/11/2021Non Beta Lactam Hormones Beta Lactam (Cephalosporins)Non Beta Lactam • Tablets (Coated and Uncoated) • Hard Gelatin Capsules • Oral Liquids Hormones • Tablets (Coated and Uncoated) Beta Lactam (Cephalosporins) • Tablets (Coated and Uncoated)Non Beta Lactam • Tablets (Coated and Uncoated) • Hard Gelatin Capsules • Oral Liquids Hormones • Tablets (Coated and Uncoated) Beta Lactam (Cephalosporins) • Tablets (Coated and Uncoated)NoneNasser Lubowa12/11/2021
42IRF/F/424/10/2018 018/GMP/2019 GMP Cert No.CSPC Ouyi Pharmaceutical Company LimitedWorkshops 112, 113 and 117; Plot No. 88 Yangzi Road, Economic and Technological Development Zone, Shijiazhuang City Hebei Province.ChinaJi 20150135 issued by China SFDA Expiry date: 31/12/20205/24/2018RT964368/17/20188/17/2021Non beta lactam Beta Lactam (Carbapenems)Non beta lactam: • Tablets (Coated and Uncoated) • Hard Gelatin Capsules and granules • SVP - Solutions in Ampoules, Aseptically filled and Terminally Sterilised Beta Lactam: • Small Volume Parenterals - Sterile Powders for InjectionNon beta lactam: • Tablets (Coated and Uncoated) • Hard Gelatin Capsules and granules • SVP - Solutions in Ampoules, Aseptically filled and Terminally Sterilised Beta Lactam: • Small Volume Parenterals - Sterile Powders for InjectionNoneNasser Lubowa8/17/2021
43IRF/F/416/10/2018 017/GMP/2019 GMP Cert No.CSPC Zhongnuo Pharmaceuticals (Shijiazhuang) Co. LtdNo. 88 Yangzi Road, Economic &Technological, Development Zone, Shijiazhuang, Hebei, People’s Republic of China.ChinaLicense No.:20150137 License Type: HabZb Valid to 31/12/20205/24/2018RT965628/14/20188/14/2021Beta Lactam (Penicillins)Beta Lactam (Penicillins): • Tablets (Coated and Uncoated) • Hard Gelatin Capsules • Dry Oral Powders/Granules for Suspension • Small Volume Parenterals- Sterile Powders for Injection in VialsBeta Lactam (Penicillins): • Tablets (Coated and Uncoated) • Hard Gelatin Capsules • Dry Oral Powders/Granules for Suspension • Small Volume Parenterals- Sterile Powders for Injection in VialsNoneNasser Lubowa8/14/2021
44IRF/F/087/06/2019 130/GMP/2019 Cert No.Curetech SkincarePlot No. 33 & 34, Phase IV, Bhatoli Kalan, Baddi, Distt. Solan (H.P) 173205, IndiaIndiaFORM 26: MNB/06/406 & MB/06/407 Validity 11/03/202011/20/2018RT103209, RT1032103/12/20193/12/2022Non-Beta LactamNon-Beta Lactam: • Semi-solid preparations - Ointments, creams, gels, lotions (Steroid and Non-steroid)Non-Beta Lactam: • Semi-solid preparations - Ointments, creams, gels, lotions (Steroid and Non-steroid)NoneKenneth Kiiza3/12/2022
45IRF/F/356/08/2018 R12 048/GMP/2019 GMP Cert No.Cyndea Pharma S.LPoligono Industrial Emiliano Revilla Sanz. Avenida, 31, Olvega, 42110 Soria, SpainSpain63581/15/2018RT916387/31/2018Non-beta lactam (sex-hormones):Non-beta lactam (sex-hormones): • Soft gelatin capsulesNon-beta lactam (sex-hormones): • Soft gelatin capsulesNoneKaleebu Frank7/31/2021
46024/GMP/2019 DRDelpharm Milano S.R.LVia Carnavale 1 20090 Segrate (Milan Italy), ItalyItaly12/17/2018RT1044271/28/20191/28/2022Non-Beta LactamNon-Beta Lactam TabletsNon-Beta Lactam TabletsNone1/28/2022
47IRF/F/008/01/2019 014/GMP/2019 GMP Cert No.Demo SA Pharmaceutical Industry21st Km National Road, Athens, Lamia 14568 Kryoneri, Attiki, GreeceGreece0000000026/14/14/20/2017RT8189210/16/2018filling of Small Volume Parenterals (penems)filling of Small Volume Parenterals (penems)filling of Small Volume Parenterals (penems)NoneAmoreen Naluyima10/16/2021
48147/GMP/2018 DRDenk Pharma GmbH & Co. KGGollstr. 1, 84529 Tittmoning, GermanyGermany2/7/2018RT923309/14/20189/14/2021Non Beta LactamTablets Hard Gelatin CapsulesTablets Hard Gelatin CapsulesNoneDenis Mwesigwa9/14/2021
49IRF/F/042/02/2019 GMp Cert No. 009/GMP/2020Deva Holdings A.S.Cerkezkoy Organize Sanayi Bolgesi, Karaagac Mah., Ataturk Cad., No.: 32 Kapakli Tekirdag - TurkeyTurkey1/4/2018RT9133410/23/201810/23/2021Non-beta lactam Penicllins Cephalosporins InhalersNBL Tablets Hard gelatin capsules Oral liquids Dry powder for suspension Semi solids Penicllins Tablets Dry powder for suspension Caphalosporins Tablets Dry powder for suspension Powders for injection Inhalers Metered dose inhalersNBL Tablets Hard gelatin capsules Oral liquids Dry powder for suspension Semi solids Penicllins Tablets Dry powder for suspension Caphalosporins Tablets Dry powder for suspension Powders for injection Inhalers Metered dose inhalersNoneAmoreen Naluyima10/23/2021
50IRF/F/089/07/2019 (EAC) 143/GMP/2019 Cert No.Dinlas Pharma EPZ LimitedPlot No. 7149/121 Mombasa Road, Syokimau P. O Box 22661 - 00505 Nairobi, KenyaKenyaRegistration No. PPB/D/2174 & License No. BU2019001381/14/2019RT105844 RT1058454/26/20194/26/2022Oral Solid Dosage Forms Oral Liquid Dosage Forms Topical PreparationOral Solid Dosage Forms: Tablets, Hard Gelatin Capsules Oral Liquid Dosage Forms: Liquids, suspensions, syrups Topical Preparation: Creams, OintmentsOral Solid Dosage Forms: Tablets, Hard Gelatin Capsules Oral Liquid Dosage Forms: Liquids, suspensions, syrups Topical Preparation: Creams, OintmentsNoneDennis Mwesigwa4/26/2022
51137/GMP/2018 DREli Lilly and CompanyLilly Technology Center, Building 312/314, 360,401, Indianapolis, In, 46221, United StatesUnited States Of America12/5/2017RT902979/7/20189/7/2021BiologicalSmall Volume Parenteral (Insulin)Small Volume Parenteral (Insulin)NoneDenis Mwesigwa9/7/2021
52IRF/F/399/10/2018 R12 190/GMP/2018 GMP Cert No.Emcure Pharmaceuticals LimitedLane 03, Phase II, SIDCO Industrial Complex, Bari Brahmana Jammu India.IndiaLicense No.: Su 20160080 Type Number: HabZb Issued by: Jiangsu Food and Drug Administration Valid to: Dec.31, 20204/17/2018RT953398/28/20188/28/2021Non beta-lactamNon beta-lactam. • Tablets. • Hard gelatin capsules. • Oral liquidsNon beta-lactam. • Tablets. • Hard gelatin capsules. • Oral liquidsNoneVictoria Kwesiga8/28/2021
53IRF/F/015/02/2019 030/GMP/2019 GMP Cert No.Encube Ethicals Pvt. LimitedPlot no. C-1,Madkaim Industrial Estate, Madkaim, Post Mardol, Ponda, Goa-403404, IndiaIndiaNo.362 and 361 dated 07/01/2017, Issued by Directorate Of Food And Drug Administration, Goa, valid up to 31.02.20217/17/2017RT85831/RT8583211/30/2018Non-Beta LactamNon-Beta Lactam: - Topical semi solid preparations (creams, gels, ointments and lotions)Non-Beta Lactam: - Topical semi solid preparations (creams, gels, ointments and lotions)NoneNambasa Victoria11/30/2021
54IRF/L/034/02/2019 153/GMP/2019 Cert No.Eram Pharmaceutical Industries LimitedLugazi, along Jinja – Kampala Highway, Buikwe DistrictUgandaNDA/PRE/PMA/3253 valid up to 31/12/20181/17/20191/17/2022Non beta-lactamNon beta-lactam: • Oral liquids • Oral powders in sachetsNon beta-lactam: • Oral liquids • Oral powders in sachetsNone1/17/2022
55IRF/F/412/10/2018 GMP Cert No. 119/GMP/2021Eskayef Pharmaceuticals Ltd (Rupganj Plant)Murapara, Rupganj, Narayanganj, BangladeshBangladeshLicense No. 306 – Valid until 07/12/2019 License No. 509 – Valid until 07/12/2019 GMP certificate No. DGDA/6-214/12337 - valid until 31/08/195/4/2017RT822279/24/20189/24/2021Beta Lactam preparations Non-beta lactam preparationsBeta Lactam preparations Penicillin Tablets Capsules SVP powders for injection Powders for Oral suspension Penems SVP powders for injection Non-beta lactam preparations General preparations Powders in sachetsBeta Lactam preparations Penicillin Tablets Capsules SVP powders for injection Powders for Oral suspension Penems SVP powders for injection Non-beta lactam preparations General preparations Powders in sachetsNoneNakimuli Eunice Lukakamwa9/24/2021
56020/GMP/2019 DREver Pharma Jena GmbhOtto-Schott-Str. 15, Jena Thueringen, 07745, GermanyGermany6/21/2018RT95880/RT1001901/23/20191/23/2022Aseptically Prepared Teminally SterilizedAseptically Prepared Small Volume Parenterals Prefilled syringes Teminally Sterilized Small Volume Parenterals Prefilled syringes Solids and ImplantsAseptically Prepared Small Volume Parenterals Prefilled syringes Teminally Sterilized Small Volume Parenterals Prefilled syringes Solids and ImplantsNoneKaleebu Frank1/23/2022
57023/GMP/2019 DREver Pharma Jena GmbhBruseller Str. 18, 07747, GermanyGermany6/21/2018RT958801/30/20191/30/2022Aseptically Prepared (Secondary Packaging Only)Aseptically Prepared (Secondary Packaging Only) Small Volume ParenteralsAseptically Prepared (Secondary Packaging Only) Small Volume ParenteralsNoneDenis Mwesigwa1/30/2022
58IRF/F/441/12/2018 213/GMP/2018 GMP Cert No.Famar Orleans SAS5 Avenue De Concyr, F-45071 Orleans, Cedex 2, FranceFranceM 17/0488/1/2016RT7205210/23/2018Non-beta lactamNon-beta lactam: • Dispersible TabletsNon-beta lactam: • Dispersible TabletsNoneKeneth Kiiza10/23/2021
59IRF/F/063/04/2019 118/GMP/2019 Cert No.FARMAPRIM5 Crinilor Street, Porumbeni, Criuleni District, MD 4829, Republic of MoldovaMoldovaAMDM/MD/AF/001/2014_1, validity until 30th May 201912/11/2017RT9048912/10/201812/10/2021Non-beta lactam Hormonal, Antibiotic and GeneralNon-beta lactam Hormonal, Antibiotic and General: • Suppositories • Vaginal ovules & pessaries • Creams • Ointments • GelsNon-beta lactam Hormonal, Antibiotic and General: • Suppositories • Vaginal ovules & pessaries • Creams • Ointments • GelsNonePeter Ssali12/10/2021
60IRF/F/433/11/2018 192/GMP/2018 GMP Cert No.Farmasierra Manufacturing S.LCarretera de Irun, Km. 26,200 28709 San Sebastian De los Reyes, Madrid, SpainSpain3353E valid up to February 20204/19/2017RT8184110/26/2018Non-beta lactamNon-beta lactam: • Ophthalmic suspensions and ointmentsNon-beta lactam: • Ophthalmic suspensions and ointmentsNoneLukwago Mohammad10/26/2021
61IRF/F/361/08/2018 R12 011/GMP/2019 GMP Cert No.FDC LimitedL-56 & L-57 Phase II D Verna Industrial Estate, Verna- 403722, Salcete Goa IndiaIndia461 of form 25 valid till 31/03/202011/30/2017RT901337/27/20187/27/2021Non Beta lactamNon Beta lactam • Tablets • Hard gelatin capsules • Oral rehydration salt(ORS)Non Beta lactam • Tablets • Hard gelatin capsules • Oral rehydration salt(ORS)NoneOkello Andrew7/27/2021
62IRF/F/362/08/2018 R12 129/GMP/2018Fourrts (India) Laboratories Pvt Ltd Plant- IIPlot No.23 Venkatamangalam, Kandigai Chennai-600127IndiaTN00003031 on form 25 valid till 13.10.20219/13/2017RT875397/24/2018Non beta-lactam.Non beta-lactam. • Tablets • Hard gelatin capsulesNon beta-lactam. • Tablets • Hard gelatin capsulesNoneOkello Andrew7/24/2021
63IRF/F/108/07/2019 147/GMP/2019 Cert No.Fresenius Kabi India Private LimitedA-3,MIDC,Ranjangm Gampati,shirwi pune-412220India28D-PD/LVP/1 & Dt:10/05/20187/17/2018RT848014/30/20194/30/2022Non-Beta LactamNon-Beta Lactam: Large volume Parenterals in Polyethylene (PE) bags (Terminally sterilized)Non-Beta Lactam: Large volume Parenterals in Polyethylene (PE) bags (Terminally sterilized)NoneVictoria Kwesiga4/30/2022
64IRF/F/031/02/2019 117/GMP/2019 Cert No.Galentic Pharma (India) Pvt Ltd Unit IR-673,TTC,MIDC,Thane Belapur Road Navi Mumbai-400701. India.India25:KD-214 and 28:KD-180 valid till 202212/4/2017RT9027311/27/201811/27/2021Non-beta LactamNon-beta Lactam: • Sterile Ophthalmic ointments and gels. • Non sterile ointments, gels, creams and lotions.Non-beta Lactam: • Sterile Ophthalmic ointments and gels. • Non sterile ointments, gels, creams and lotions.NoneZaid Mwonda11/27/2021
65IRF/F/365/09/2018 R12 131/GMP/2018Galpha Laboratories LimitedVillage-Thana Baddi, Tehsil Baddi Solan Himachal Pradesh-173 205 IndiaIndiaMNB/05/195 and 196 valid up to 27/9/20209/28/2017RT880907/28/2018Non beta-lactamNon beta-lactam. • Hard gelatin Capsules • Tablets • Oral liquids for human useNon beta-lactam. • Hard gelatin Capsules • Tablets • Oral liquids for human useNoneZaidi Mwondha7/28/2021
66115/GMP/2018 DRGedeon Richter PlcH-1103 Budapest, Gyomroi ut 19-21 HungaryHungary8/13/2013RT46073/RT460727/18/20187/18/2021Non Beta LactamTablets ( Hormones)Tablets ( Hormones)NoneDenis Mwesigwa7/18/2021
67IRF/F/410/10/2018 GMP Cert No. 026/GMP/2019General Pharmaceuticals Limited (Unit 2)Karolsurichala, Mouchak, Kaliakoir, Gazipur – Bangladesh.BangladeshForm 14: License number 488 – Valid until 13/10/2018 Form 14: License number 283 – Valid until 13/10/201810/19/2017RT887409/20/20189/20/2021Non-beta lactam sterile SVP preparationsNon-beta lactam sterile SVP preparations: General preparations (Non-steroid) • Ampoules. • Ophthalmic preparations (in LDPE bottles). • Pre-filled syringes. Steroid preparations • Ophthalmic preparations (in LDPE Bottles)Non-beta lactam sterile SVP preparations: General preparations (Non-steroid) • Ampoules. • Ophthalmic preparations (in LDPE bottles). • Pre-filled syringes. Steroid preparations • Ophthalmic preparations (in LDPE Bottles)None9/20/2021
68IRF/F/012/01/2019 022/GMP/2019 GMP Cert NoGland Pharma LimitedSurvey No. 143 to 148, 150 & 151, D.P.Pally, Dundigal Post, Dundigal – Gandimaisamma Mandal, Medchal-Malkajgiri District, Hyderabad- 500 043 TelanganaIndia103/AP/RR/97/F/R Dated 24/01/2018 on Form 28, valid up to 31st August, 2022.2/13/2018RT9316111/20/2018Non-Beta lactamNon-Beta lactam • SVP (Liquid Ampoules and Liquid vials)Non-Beta lactam • SVP (Liquid Ampoules and Liquid vials)NoneOkello Andrew11/20/2021
69IRF/F/400/09/2018 R12 151/GMP/2018 GMP CERT NoGland Pharma LtdPlot No.42 to 52,Sy No.166,171,172 & 177,TSIIC,Phase111,Pashamylaram(V) Patancheru (M),Medak District 502307 Telangana state, IndiaIndia1929/E(R)/TS/2015 Valid until 28th May 20203/6/2017RT803398/21/20188/21/2021Non Beta LactamNon Beta Lactam • Aseptically filled SVP solution in glass ampoules (suite 7) • Aseptically filled SVP Lyophilizate in glass vials (suite 2)Non Beta Lactam • Aseptically filled SVP solution in glass ampoules (suite 7) • Aseptically filled SVP Lyophilizate in glass vials (suite 2)NoneVictoria Kwesiga8/21/2021
70080/GMP/2019 DRGlaxo Operations UK Limited (Trading as Glaxo Wellcome Operations)Priory Street, Ware, SG120DJ – United KingdomUnited Kingdom4/26/2018RT955505/22/20195/22/2022Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneKaleebu Frank5/22/2022
71191/GMP/2018 DRGlaxo Operations UK LtdHarmire Road, Barnard Castle, Durham, DL 12 8DTUnited Kingdom4/26/2018RT9555111/30/201811/30/2021Cephalosporin Non-Beta LactamCephalosporin Tablets Oral dry powders for suspension Non-Beta Lactam Pressurised inhalers Semi solidsCephalosporin Tablets Oral dry powders for suspension Non-Beta Lactam Pressurised inhalers Semi solidsNoneKaleebu Frank11/30/2021
72027/GMP/2019 DRGlaxosmithkline Manufacturing S.P.AVia A. Fleming, 2-37135 Verona - ItalyItaly11/18/2016RT761681/31/20191/31/2022CephalosporinCephalosporin: Small Volume ParenteralsCephalosporin: Small Volume ParenteralsNone1/31/2022
73170/GMP/2018 DRGlaxoSmithKline Manufacturing SpAStrada Provinciale Asolana N.90 (Loc. San Polo), Torrile (PR), 43056, Italy.Italy8/7/2018RT9555210/30/201810/30/2021Non-Beta LactamNon-Beta Lactam Small Volume Parenteral Solutions (Aseptically filled and terminally sterilised in ampoules and vials)Non-Beta Lactam Small Volume Parenteral Solutions (Aseptically filled and terminally sterilised in ampoules and vials)NoneKaleebu Frank10/30/2021
74044/GMP/2019 DRGlaxoSmithKline, LLC1011 North Arendell Avenue Zebulon, North Carolina 27597, USA.United States Of America7/31/2017RT862622/12/20192/12/2022Non-Beta LactamNon-Beta Lactam: Pressurised preparations (Multi-dose powder inhalation)Non-Beta Lactam: Pressurised preparations (Multi-dose powder inhalation)None2/12/2022
75IRF/F/027/02/2019 041/GMP/2019 GMP Cert No.Glenmark Pharmaceuticals LimitedVillage Kishanpura, Baddi, Nalagarh Road, Tehsil Baddi, Distt. Solan (H.P)-173205, IndiaIndiaMNB/05/182 and MB/05/226 valid up to 19/09/202011/7/2017RT8928212/8/201812/8/2021Non-beta LactamNon-beta Lactam: • Tablets (coated and uncoated) • Oral liquid preparations • Semi solid preparations(creams ,ointments and lotions) for external useNon-beta Lactam: • Tablets (coated and uncoated) • Oral liquid preparations • Semi solid preparations(creams ,ointments and lotions) for external useNoneNambasa Victoria12/8/2021
76IRF/F/415/10/2018 210/GMP/2018 Cert No.Glenmark Pharmaceuticals LtdPlot E-37, 39, D road, MIDC, Satpur, Nashik 422007, Maharashtra State, India.IndiaForm 25: 803 and form 28: 54310/22/2015RT655909/11/20189/11/2021Non-beta lactamNon-beta lactam: • Tablets (coated & uncoated) • Hard gelatin Capsules, • Oral Liquids, • External Powders • Medicated shampoo • External semi-solids (lotions, creams, drops, gels and ointments)Non-beta lactam: • Tablets (coated & uncoated) • Hard gelatin Capsules, • Oral Liquids, • External Powders • Medicated shampoo • External semi-solids (lotions, creams, drops, gels and ointments)NoneAtumanya Amos9/11/2021
77IRF/F/420/10/2018 052/GMP/2019 GMP Cert No.Gufic Life Sciences Private Limited,Survey No. 171, N.H. No-8, Near Frid, Kabilpore, City- Navsari 396424, Dist. Navsari, Gujarat state, India.IndiaG/28/14992/28/2018RT937389/25/2018Non beta lactamNon beta lactam: • Small volume parenterals (liquids & lyophilized powders in vials)Non beta lactam: • Small volume parenterals (liquids & lyophilized powders in vials)NoneAtumanya Amos9/25/2021
78IRF/F/045/02/2019 154/GMP/2019 Cert No.Hester Biosciences LimitedVillage; Merda-Adraj, Taluka: Kadi, District Mehsana Gujarat-382721 IndiaIndiaG/1016 valid until 31/12/20217/24/2018RT99685, RT9968612/4/201812/4/2021Veterinary production line(s)Veterinary production line(s): •Inactivated viral and bacterial vaccines in SVP vials (liquids and freeze-dried) •Live attenuated viral and bacterial vaccines in SVP vials ( liquids and freeze-dried)Veterinary production line(s): •Inactivated viral and bacterial vaccines in SVP vials (liquids and freeze-dried) •Live attenuated viral and bacterial vaccines in SVP vials ( liquids and freeze-dried)NoneZaid Mwonda12/4/2021
79IRF/F/103/07/2019 106/GMP/2019 GMP Cert No.Hetero Laboratories Limited - Unit VSy. No. 439,440,441 &458, Polepally Village, Jadcherla Mandal, Mahaboobnagar District, Pin -509 301, Telangana, IndiaIndiaForm 25: 50/MN/AP/2009/F/R/ validity 18/12/20198/8/2018RT998533/19/20193/19/2022Non-Beta LactamNon-Beta Lactam: • Tablets, coated and uncoated (General) • Hard gelatine capsules (General) • Hard gelatine capsules (Oncology)Non-Beta Lactam: • Tablets, coated and uncoated (General) • Hard gelatine capsules (General) • Hard gelatine capsules (Oncology)NoneKenneth Kiiza3/19/2022
80IRF/F/104/07/2019 151/GMP/2019 Cert No.Hetero Laboratories Limited – Unit VISy. No. 410-411, Polepally Village, Jadcherla Mandal, Mahaboobnagar District, Pin -509 301, Telangana, IndiaIndiaFORM 28; 28/MN/AP/2011/F/R VALIDITY 30/06/2021 FORM 25: 26/MN/AP/2010/F/R VALIDY 10/06/20208/8/2018RT998533/22/20193/22/2022Non-Beta Lactam (Oncology)Non-Beta Lactam (Oncology): • Tablets (coated and uncoated) • SVP liquids (aseptically filled and terminally sterilized) in vials • SVP lyophilized powders (aseptically filled) in vialsNon-Beta Lactam (Oncology): • Tablets (coated and uncoated) • SVP liquids (aseptically filled and terminally sterilized) in vials • SVP lyophilized powders (aseptically filled) in vialsNoneKenneth Kiiza3/22/2022
81IRF/F/088/06/2019 152/GMP/2019 Cert No.Hetero Laboratories Limited- Unit VIIPlot No.14, Survey No.: 50, Phase: III, Industrial Development Area, Jeedimetla, Hyderabad, PIN- 500 055, Telangana, IndiaIndiaForm 25: 24/RR/AP/2010/F/R validity- 20/05/20208/8/2018RT998533/15/20193/15/2022Non-Beta LactamNon-Beta Lactam: • Inhalers (pressurised metered dose)Non-Beta Lactam: • Inhalers (pressurised metered dose)NoneKenneth Kiiza3/15/2022
82IRF/F/061/04/2019 104/GMP/2019 GMP Cert No.Hilton Pharmaceuticals (Pvt.) LimitedPlot No. 13-14, Sector 15, Korangi Industrial Area in Karachi-74900. PakistanPakistanForm no. 000136 valid up to 20193/1/2018RT9380011/30/201811/30/2021Non-beta lactam preparations Cephalosporin Veterinary, Non-beta lactam:Tablets Hard gelatin capsules Dry powder for oral suspension Oral liquid preparations SVPs Cephalosporin Dry powder for oral suspension Hard gelatin capsules Veterinary Oral liquid preparations Dry powder for oral suspensionTablets Hard gelatin capsules Dry powder for oral suspension Oral liquid preparations SVPs Cephalosporin Dry powder for oral suspension Hard gelatin capsules Veterinary Oral liquid preparations Dry powder for oral suspensionNoneDenis Mwesigwa11/30/2021
83IRF/F/426/11/2018 203/GMP/2018 GMP Cert No.Indiana Ophthalamics135,136,137, G.I.D.C Estate Wadhvan 363035 - India.IndiaG/197 valid up to 11/09/20194/25/2017RT82061/RT820639/28/20189/28/2021Non beta lactamNon beta lactam: • Sterile eye drops (solutions and suspensions) • Sterile eye ointmentsNon beta lactam: • Sterile eye drops (solutions and suspensions) • Sterile eye ointmentsNoneKaleebu Frank9/28/2021
84IRF/F/418/10/2018 019/GMP/2019 GMP Cert No.Inject Care Parenterals Pvt LimitedPlot No 130, Silvassa Road Gidc Vapi-396 195 Gujarat India.IndiaG/28/1216 valid up to 27/03/20213/1/2018RT937809/21/20189/21/2021Aseptically filled beta lactam powderAseptically filled beta lactam powder: • Small volume parenterals (cephalosporins) • Small volume parenterals (penicillins)Aseptically filled beta lactam powder: • Small volume parenterals (cephalosporins) • Small volume parenterals (penicillins)NoneAtumanya Amos9/21/2021
85IRF/F/369/09/2018 R12 211/GMP/2018 GMP Cert No.Innova Captab Pvt. Ltd1281/1, Hilltop, Industrial Estate, Near EPIP, Phase-1, Jharmajri, Baddi, Distt. Solan [H.P] India.IndiaMNB/16/970 valid up to 09.03.2022 & MB/09/803 valid up to 28.03.2020 for manufacture and sale10/18/2016RT750948/3/20188/3/2021Beta lactam (cephalosporin)Beta lactam (cephalosporin) • Small volume powders for injection • Tablets (coated and uncoated) • Hard Gelatin Capsules • Powders for oral useBeta lactam (cephalosporin) • Small volume powders for injection • Tablets (coated and uncoated) • Hard Gelatin Capsules • Powders for oral useNoneAtumanya Amos8/3/2021
86IRF/F/077/05/2019 083/GMP/2019 Cert No.Intervet International B.V.Wim de Körverstraat 35 5831 AN Boxmeer, The NetherlandsNetherlandsAuthorization No. 0324-FIGL, granted on 29-Aug-20173/15/2017RT80628/RT8062912/4/2018Biological (vaccines)Biological (vaccines): • Live freeze-dried (multivalent) vaccines (for veterinary use) • Live frozen poultry vaccines (for veterinary use)Biological (vaccines): • Live freeze-dried (multivalent) vaccines (for veterinary use) • Live frozen poultry vaccines (for veterinary use)NonePeter Ssali12/4/2021
87IRF/F/432/11/2018 071/GMP/2019 GMP Cert No.Ipanema Industria De Produtos Veterinarios LtdaRaposo Tavares Road, Km 113-Aracoiaba da Serra city/Sao Paulo, Brazil.BrazilSP 000339-5 Validity 02/03/20195/8/2018RT9595010/5/2018Non Beta LactamNon Beta Lactam: • External Liquid (ectoparasiticide)Non Beta Lactam: • External Liquid (ectoparasiticide)NoneMutyaba Michael10/5/2021
88IRF/F/102/07/2019 127/GMP/2019 Cert No.JB Chemicals and Pharmaceuticals Limited128/1, GIDC Industrial Estate, Ankleshwar- 393002, Bharuch district, Gujarat, IndiaIndiaG/394 and G/167 issued by the Food & Drug Administration Gujarat state valid until 31/12/20226/6/2018RT968234/26/20194/26/2022Non ?-lactamNon ?-lactam: Tablets, Oral liquids (Suspensions and syrups), Capsules (Hard gelatin)Non ?-lactam: Tablets, Oral liquids (Suspensions and syrups), Capsules (Hard gelatin)NoneNasser Lubowa4/26/2022
89IRF/L/019/02/2019 122/GMP/2019 Cert No.Kampala Pharmaceutical Industries (1996) LimitedStretcher Road, Plot M444B, Ntinda, KampalaUgandaNDA/PRE/PMC/236712/20/201812/20/2021Non- Beta Lactam Penicillins Secondary PackagingNon- Beta Lactam •Tablets •Capsules •Creams and ointments Penicillins •Tablets •Capsule (HG). •Powder for oral suspension Secondary Packaging •Booster Mama Kit •Protector condoms •Pilplan Plus, Injectaplan •AquasafeNon- Beta Lactam •Tablets •Capsules •Creams and ointments Penicillins •Tablets •Capsule (HG). •Powder for oral suspension Secondary Packaging •Booster Mama Kit •Protector condoms •Pilplan Plus, Injectaplan •AquasafeNoneSsali Peter12/20/2021
90IRF/F/377/09/2018 R12 053/GMP/2019 GMP Cert No.Karnataka Antibiotics and Pharmaceuticals LtdPlot 14 Phase II Peenya Industrial Area Bangalore -560058IndiaSP-96/84 & NP-152/841/11/2016RT678887/31/2018Beta lactam Penicillin Beta lactam Cephalosporin Non Beta lactamBeta lactam Penicillin • Dry powders for Injection Beta lactam Cephalosporin • Dry powders for Injection Non Beta lactam • Dry powders for injectionBeta lactam Penicillin • Dry powders for Injection Beta lactam Cephalosporin • Dry powders for Injection Non Beta lactam • Dry powders for injectionNoneOkello Andrew7/31/2021
91079/GMP/2019 DRKela N.V.Sint Lenaartseweg 48, 2320 Hoogstragten, Belgium.Belgium12/15/2016RT760105/22/20195/22/2022Non-Beta Lactam Hormones PenicillinNon-Beta Lactam: Tablets, SVP Liquids in Vials, LVP Liquids, Oral Liquids, Oral dry powders for suspension Hormones: SVP, LVP Liquids Penicillin: SVP Powders in Vials (Aseptically filled), LVP LiquidsNon-Beta Lactam: Tablets, SVP Liquids in Vials, LVP Liquids, Oral Liquids, Oral dry powders for suspension Hormones: SVP, LVP Liquids Penicillin: SVP Powders in Vials (Aseptically filled), LVP LiquidsNoneKaleebu Frank5/22/2022
92IRF/F/101/07/2019 135/GMP/2019 Cert No.Kesar Pharma (P) LimitedPlot No. 50/2 Village Bileshwapura Chhatral - 382729,Ta: Kalol, Dist.: Gandhinagar, Gujarat IndiaIndiaG/28/1442 and G/25/2000 valid till 01/05/2023 Issued by the Food and Drug control Administration Gujarat India1/16/2018RT91690, RT916914/23/20194/23/2022Non ?-lactamNon ?-lactam: Tablets, Oral liquids (Suspensions and syrups), Semi Solids (Ointments, creams, gel)Non ?-lactam: Tablets, Oral liquids (Suspensions and syrups), Semi Solids (Ointments, creams, gel)NoneNasser Lubowa4/23/2022
93IRF/F/393/09/2018 R12 131/GMP/2019 Cert No.Komipharm International Co.Ltd17, GyeongJe-Ro, Sihueng-si, Gyeonggi-Do, South KoreaKorea, Republic of (South)Manufacturing License No.: 033 first issued on 17/10/1972 by Veterinary Authority of Korea. The license is open ended and edited when the factory implements a major change, the last edition was dated 29/03/201810/26/2017RT88843/RT888448/7/20188/7/2021Non Beta Lactam (veterinary use)Non Beta Lactam (veterinary use) • VaccinesNon Beta Lactam (veterinary use) • VaccinesNoneOnen Solomon L.8/7/2021
94IRF/F/020/02/2019 120/GMP/2019 Cert No.Kremoint Pharma Pvt LtdB-8, Additional MIDC, Ambernath East, Dist. Thane, Maharashtra, India.India24-KD- 171 and 28-KD-146 Valid from 01/01/2017 to 31/12/20212/12/2018RT9311611/27/201811/27/2021Non-Beta LactamNon-Beta Lactam • External semi-solids (creams, gels and ointments)Non-Beta Lactam • External semi-solids (creams, gels and ointments)NoneAtumanya Amos11/27/2021
95082/GMP/2019 DRLabesfal Laboratorios Almiro S.A.Zona Industrial Do Lagedo, 3465-157 Santigo De Besteiros, Tondel, PortugalPortugal4/29/2019RT1102425/23/20195/23/2022Non-Beta Lactam CephalosporinNon-Beta Lactam: SVP (Aseptically prepared and Terminally sterilized) Tablets Hard gelatin capsules Cephalosporin: SVP Powders in vials (Aseptically prepared)Non-Beta Lactam: SVP (Aseptically prepared and Terminally sterilized) Tablets Hard gelatin capsules Cephalosporin: SVP Powders in vials (Aseptically prepared)NoneKaleebu Frank5/23/2022
96IRF/F/028/02/2019 090/GMP/2019 Cert No.Laborate Pharmaceutical India Limited Unit II31, Rajban Road, Nariwala, Paonta Sahib, Distt, Sirmour, Himachal Pradesh India.IndiaS-MNB/10/65 and S-MNB/10/66 valid up to 22/02/20204/10/2018RT94839/RT9484012/4/201812/4/2021Non-beta LactamNon-beta Lactam: • Aseptically filled SVP liquids • Aseptically filled Ophthalmic solutions • Tablets (coated & uncoated) • Hard gelatin capsules • Liquids for internal useNon-beta Lactam: • Aseptically filled SVP liquids • Aseptically filled Ophthalmic solutions • Tablets (coated & uncoated) • Hard gelatin capsules • Liquids for internal useNoneAtumanya Amos12/4/2021
97069/GMP/2019 DRLaboratoies Besins International13 rue Perier BP 41, 92122 Montrouge Cedex - FranceFrance5/11/2018RT960574/4/20194/4/2022Non-Beta Lactam hormonesNon-Beta Lactam hormones: Semi-solid gelsNon-Beta Lactam hormones: Semi-solid gelsNoneKaleebu Frank4/4/2022
98IRF/F/434/11/2018 064/GMP/2019 GMP Cert No.Laboratorios Hipra S.AAvda la Selva, 135 17170 Amer, Girona, SpainSpain0745 issued by the Spanish Agency for Medicine and health products. Valid up to 20192/20/2018RT9343510/23/2018Vaccines Non Beta Lactam Beta LactamVaccines: Live attenuated bacterial and Viral vaccines in SVP vials Inactivated bacterial and viral vaccines in SVP vials Non Beta Lactam: Oral liquids Injectable Liquids Beta Lactam: Injectable LiquidsVaccines: Live attenuated bacterial and Viral vaccines in SVP vials Inactivated bacterial and viral vaccines in SVP vials Non Beta Lactam: Oral liquids Injectable Liquids Beta Lactam: Injectable LiquidsNoneLukwago Mohammad10/23/2021
99IRF/F/440/12/2018 212/GMP/2018 GMP Cert No.Laboratorios Inibsa, S.ACarretera de Sabadell a Granollers, Llica de Vall, 08185 Barcelona, SpainSpain0230 (GMP certificate no. NCF/1849/001/CAT valid till September 2021)10/25/2016RT7531510/19/201810/19/2021Non-beta lactamNon-beta lactam: • Small volume parenteral solution (Pre-filled Dental cartridges) aseptically filledNon-beta lactam: • Small volume parenteral solution (Pre-filled Dental cartridges) aseptically filledNoneKeneth Kiiza10/19/2021
100025/GMP/2019Lilly Del Caribe, Inc12.6 KM 65TH Infantry Road (PR01), CAROLINA, Puerto Rico 00985, Puerto RicoUnited States Of America12/5/2017RT902991/30/20191/30/2022Non-Beta LactamNon-Beta Lactam: Tablets (Bulk manufacturing)Non-Beta Lactam: Tablets (Bulk manufacturing)None1/30/2022
101138/GMP/2018 DRLilly FranceFegersheim, Za Center De Production, 2 Rue Du Colonel Lilly, Fegersheim, 67640, FranceFrance12/5/2017RT902989/7/20189/7/2021BiologicalSmall Volume Parenteral (Insulin)Small Volume Parenteral (Insulin)NoneDenis Mwesigwa9/7/2021
102168/GMP/2018 DRLilly S.ALilly SA, Avda. Industria 30, 28108, Alcobendas, Madrid Spain.Spain6/12/2018RT9701010/29/201810/29/2021Non-Beta LactamNon-Beta Lactam TabletsNon-Beta Lactam TabletsNoneKaleebu Frank10/29/2021
103IRF/F/423/11/2018 162/GMP/2018 GMP Cert No.Lupin Limited (Nagpur)Plot No. 6A, sector 17, Special economic zone, Mihan, Nagpur 441108, Maharashstra, India. (Block 1).India25-ND/59 dated 27/08/2018 from Food and Drug administration (Maharashtra state) Valid from 7th September 2018 to 6th September 2023.5/23/2017RT826509/18/2018Non-beta lactamNon-beta lactam; • Tablets (coated and uncoated)Non-beta lactam; • Tablets (coated and uncoated)NoneKaleebu Frank9/18/2021
104IRF/F/407/10/2018 GMP Cert No. 031/GMP/2019M.J Biopharm Pvt LtdL7,MIDC Industrial Area, Taloja Dist. Raigad 410208, IndiaIndiaKD-388 (25) – valid to 31/12/2022 KD-295 (28) – valid to 31/12/2022 KD-6 (28-D) - valid to 26/04/20212/17/2017RT797788/24/2018Non beta lactam Beta lactam (Cephalosporin & Penem)Non beta lactam. • Coated and uncoated Tablets, • Hard gelatin capsules, • Small volume parenteral solutions (ampoules, cartridges, vials and pre-filled syringes), Beta lactam (Cephalosporin & Penem) • Dry powder for injection (Vials)Non beta lactam. • Coated and uncoated Tablets, • Hard gelatin capsules, • Small volume parenteral solutions (ampoules, cartridges, vials and pre-filled syringes), Beta lactam (Cephalosporin & Penem) • Dry powder for injection (Vials)NoneVictoria Kwesiga8/24/2021
105IRF/F/048/03/2019 GMP Cert No. 060/GMP/2019Macleods Pharmaceuticals Ltd, Unit IIPlot No. 25-27, Survey No. 366, Premier Industrial Estate, Kuchigam, Daman – 396 210 (U.T) IndiaIndiaDCD/D&D/LA/2017-2018/1480 (Dt:19/01/2018) valid till 31/12/2022 & DCD/D&D/LA/2018-2019/787 (Dt: 21/08/2018) valid till 17/08/2023 on Form 28 & 25 respectively4/28/2017RT8217911/30/2018Non-Beta LactamNon-Beta Lactam: • Tablets (coated and uncoated) • Hard Gelatin Capsules • SVP – Powder vialsNon-Beta Lactam: • Tablets (coated and uncoated) • Hard Gelatin Capsules • SVP – Powder vialsNoneOkello Andrew11/30/2021
106IRF/F/439/12/2018 049/GMP/2019 GMP Cert No.Malik Lifesciences Pvt. LtdPlot No.: 16, Vardhman Industrial Estate, Village Bahadarpur Saini, NH-58 Roorkee- 247667, Haridwar, Uttarakhand, IndiaIndiaForm 28 48/UA/SC/P-2015 to 21st November 20189/26/2018Penicillin CephalosporinPenicillin • Tablets (coated and uncoated) • Hard gelatin capsules • Powders for oral suspension (dry syrups) Cephalosporin • Tablets (coated and uncoated) • Powders for oral suspension (dry syrups)Penicillin • Tablets (coated and uncoated) • Hard gelatin capsules • Powders for oral suspension (dry syrups) Cephalosporin • Tablets (coated and uncoated) • Powders for oral suspension (dry syrups)NoneSsali Peter9/26/2021
107IRF/F/386/09/2018 R12 206/GMP/2018 GMP Cert No.Maneesh Exports (EOU)Plot D-16/7, TTC Industrial Area, MIDC Turbhe, Navi Mumbai – 400 703, Dist. Thane, Maharashtra, IndiaIndiaForm 26 License No. 28: KD- 381 by Food and Drug Administration Valid up to 15/01/201911/21/2017RT897957/19/20187/19/2021Beta Lactam (Penicillin)Beta Lactam (Penicillin) • Tablets (coated and uncoated) • Hard Gelatin Capsules • Dry Powders for Oral Suspension • Small Volume Parenterals- Dry Powders for Injection in VialsBeta Lactam (Penicillin) • Tablets (coated and uncoated) • Hard Gelatin Capsules • Dry Powders for Oral Suspension • Small Volume Parenterals- Dry Powders for Injection in VialsNoneNasser Lubowa7/19/2021
108IRF/F/360/08/2018 R12 012/GMP/2019 GMP Cert No.Marcyrl Pharmaceuticals IndustriesEl Obour City, Western Extension Parts No. 5-12, Block 20005Egypt00202/4665165010/11/2017RT884587/5/20187/5/2021Non Beta lactamNon Beta lactam • Tablets (coated and uncoated) • Capsules hard gelatin • Capsules soft gelatin • Oral powders (sachets) • Suppositories Hormonal • Creams, Ointments and gelsNon Beta lactam • Tablets (coated and uncoated) • Capsules hard gelatin • Capsules soft gelatin • Oral powders (sachets) • Suppositories Hormonal • Creams, Ointments and gelsNoneKenneth Kiiza7/5/2021
109IRF/F/090/07/2019 072/GMP/2020 GMP Cert No.Medical Union Pharmaceuticals LimitedPlot no. 1, 2nd Industrial Zone, 6th of October City, Giza Governorate, EgyptEgypt1/19985/28/2018RT96561 / RT1083434/30/20194/30/2022Biological productsBiological products: Small Volume Parenteral liquids (in vials) – aseptically preparedBiological products: Small Volume Parenteral liquids (in vials) – aseptically preparedNoneLukwago Mohammad4/30/2022
110IRF/F/107/07/2019 GMP Cet No. 248/GMP/2020Medical Union Pharmaceuticals LimitedAbu Sultan, CR 13363 Ismailia, EgyptEgyptFM-LPM-02 Serial no. 00004/20185/28/2018RT96561 / RT1083434/24/20194/24/2022Non-beta lactam PenicillinNon-beta lactam: Tablets, Oral liquids, Small Volume Parenteral liquids, External semi-solids, Suppositories, Aerosols Penicillin: Powders for oral suspension, Sterile powders for injection – aseptically producedNon-beta lactam: Tablets, Oral liquids, Small Volume Parenteral liquids, External semi-solids, Suppositories, Aerosols Penicillin: Powders for oral suspension, Sterile powders for injection – aseptically producedNoneMuhammad I. Lukwago4/24/2022
111IRF/F/013/02/2019 108/GMP/2019 Cert No.Medicamen Organics LtdPlot No. 60, sector -6a, IIE, Sidcul, Ranipur, Haridwar, Uttarakhand, IndiaIndia63/UA/2007 validity 18/05/20224/26/2018RT9556711/20/201811/20/2021Non-Beta LactamNon-Beta Lactam • Tablets (coated and uncoated)Non-Beta Lactam • Tablets (coated and uncoated)NoneAtumanya Amos11/20/2021
112IRF/F/044/02/2019 055/GMP/2019 GMP Cert No.Medispray Laboratories Pvt Limited, Unit II346-348 Kundaim Industrial Estate, Kundaim Goa-403115 IndiaIndia926 valid until December 2019 issued by the directorate of FDA-Goa1/4/2018RT9132012/11/2018?eta-lactam?eta-lactam: • Tablets (coated and uncoated) • Hard gelatin capsules • Dry powder for suspension without the water co-pack)?eta-lactam: • Tablets (coated and uncoated) • Hard gelatin capsules • Dry powder for suspension without the water co-pack)NoneZaid Mwonda12/11/2021
113IRF/F/408/10/2018 GMP Cert No. 033/GMP/2019Medley Pharmaceuticals LtdLane 03, Phase I, SIDCO Industrial Complex, Bari Brahmana Jammu 181133IndiaJK/01/05-06/75 & JK/01/05-06/76 on form 26 valid from 09/05/2015 to 08/05/2020 issued by the office of the controller; food & drug control organization J&K Jammu.8/2/2017RT863218/31/20188/31/2021Non Beta lactamNon Beta lactam: • Tablets (Coated and uncoated) • Hard gelatin capsules • Oral liquids (syrup & suspension)Non Beta lactam: • Tablets (Coated and uncoated) • Hard gelatin capsules • Oral liquids (syrup & suspension)NoneVictoria Kwesiga8/31/2021
114IRF/F/070/05/2019 149/GMP/2019 GMP Cert No.Medopharm Private Limited Laboratories50,Kayarembedu Village,Guduvanchery 603 202 Tamil Nadu- IndiaIndiaTN00002183 dated 17/03/2006 valid upto 16/03/2021 issued by the Department of Food safety and Drugs control Administration Government of Tamil Nadu8/24/2017RT869642/5/20192/5/2022Non-beta lactam Beta LactamNon-beta lactam: • Tablets (coated and uncoated) Beta Lactam: • Tablets (Coated and Uncoated) • Hard Shell Capsules • Dry Powder for oral suspensionNon-beta lactam: • Tablets (coated and uncoated) Beta Lactam: • Tablets (Coated and Uncoated) • Hard Shell Capsules • Dry Powder for oral suspensionNoneWilberforce Kwiringira2/5/2022
115IRF/F/096/07/2019 103/GMP/2019 GMP Cert dateMedreich Limited (Unit 8)Sy. No 14 and 15, Gundarahalli Village Sulibele Hobli, Hoskote Taluk, Bangalore Rural Dist. 562 114, IndiaIndiaKTK/25/634/2015 and KTK/28/426/2015 dated 06/05/2015 from Drug Controller & Licensing Authority (Karnataka state) Valid up to 05/05/20204/18/2018RT953664/5/2019Beta-lactam (Penicillin)Beta-lactam (Penicillin): Tablet, Hard Gelatine Capsules, Powder for oral suspensionBeta-lactam (Penicillin): Tablet, Hard Gelatine Capsules, Powder for oral suspensionNoneZaidi Mwondha4/5/2022
116IRF/F/358/08/2018 R12 112/GMP/2019 Cert No.Memphis company for pharmaceutical and chemical industriesPlot No. 8 EI Sawah Al-ameria Cairo, Egypt.Egypt0024/2018 (Open Validity)7/16/20187/16/2021Non ?-lactamNon ?-lactam • Tablets coated and uncoated • Capsules (Hard gelatin) • Oral liquids • Creams and ointment • SVP Injection solutions (in Ampoules and Vials)Non ?-lactam • Tablets coated and uncoated • Capsules (Hard gelatin) • Oral liquids • Creams and ointment • SVP Injection solutions (in Ampoules and Vials)NoneKenneth Kiiza7/16/2021
117200/GMP/2018 DRMerck KGaAFrankfurter Strasse 250; D-64293 Darmstadt, GermanyGermany3/22/2017RT8085411/30/2018Non-Beta LactamNon-Beta Lactam Tablets Small Volume ParenteralsNon-Beta Lactam Tablets Small Volume ParenteralsNoneKaleebu Frank11/30/2021
118028/GMP/2019 DRMerck Serono S.P.AVia Luigi Einaudi 11, 1-00012 Gudonia, Montecelio - ItalyItaly10/10/2017RT883821/31/20191/31/2022Quality Control TestingQuality Control Testing Chemical/Physical testing Microbiological testing (Sterility) Microbiological testing (non-sterility) Biological testing Batch certification / releaseQuality Control Testing Chemical/Physical testing Microbiological testing (Sterility) Microbiological testing (non-sterility) Biological testing Batch certification / releaseNone1/31/2022
119IRF/F/355/08/2018 R12 128/GMP/2018Merial4 Chemin du Calquet 31000 Toulouse FranceFranceV 0033/7812/4/2017RT902227/27/2018Non-beta lactam:NBL Topical solutions (Ectoparasiticides) Injectable powder in sachets (Isometamidium powder for injection- Trypamidium) Solutions for injection (Aseptically filled and terminally sterilized small volume parenterals and large volume parenterals)NBL Topical solutions (Ectoparasiticides) Injectable powder in sachets (Isometamidium powder for injection- Trypamidium) Solutions for injection (Aseptically filled and terminally sterilized small volume parenterals and large volume parenterals)NoneKaleebu Frank7/27/2021
120IRF/F/413/10/2018 015/GMP/2019 GMP Cert No.Meridian Enterprises Pvt LtdPlot 418 GIDC, Kabilpore, Navsari, Gujarat- IndiaIndiaForm 28: G/1064 and G/977; Validity 31/12/20215/15/2018RT961598/24/20188/24/2021Non-beta lactamNon-beta lactam: • Suppositories • Tablets (coated and uncoated) • Liquids for external use (Nasal preparations, and disinfectants)Non-beta lactam: • Suppositories • Tablets (coated and uncoated) • Liquids for external use (Nasal preparations, and disinfectants)NoneDennis Mwesigwa8/24/2021
121IRF/F/427/11/2018 186/GMP/2018 GMP Cert No.Micro Labs LimitedPlot No.: S-155 to S-159 & N1, Phase III to IV, Verna Industrial Estate, Verna, Salcette, Goa – 403722, IndiaIndia652, renewed from 8th March 2014 to 7th March 201912/14/2016RT773389/11/2018Non-beta oral solid dosageNon-beta oral solid dosage; • Tablets (coated and uncoated) • Hard gelatin capsulesNon-beta oral solid dosage; • Tablets (coated and uncoated) • Hard gelatin capsulesNoneSsali Peter9/11/2021
122IRF/F/427/11/2018 186/GMP/2018 GMP Cert No.Micro Labs LimitedPlot No.: S-155 to S-159 & N1, Phase III to IV, Verna Industrial Estate, Verna, Salcette, Goa – 403722, IndiaIndia652, renewed from 8th March 2014 to 7th March 201912/14/2016RT773389/11/2018Non-beta oral solid dosageNon-beta oral solid dosage Tablets (coated and uncoated) Hard gelatin capsulesNon-beta oral solid dosage Tablets (coated and uncoated) Hard gelatin capsulesNoneSsali Peter9/11/2021
123IRF/F/105/07/2019 GMP Cert No. 025/GMP/2020Minapharm PharmaceuticalsMina Street, 03rd Industrial zone A2-10th of Ramadhan City, EgyptEgyptManufacturing license no. 1 issued 19911/30/2018RT921564/15/20194/15/2022Non-beta lactamNon-beta lactam: Tablets (Uncoated & Coated), Capsules (Hard gelatin), SVP liquids (Ampoules & Vials), SVP Lyophilisates, External Semi solids (Gels, Shampoos, lotions, Creams & Ointments)Non-beta lactam: Tablets (Uncoated & Coated), Capsules (Hard gelatin), SVP liquids (Ampoules & Vials), SVP Lyophilisates, External Semi solids (Gels, Shampoos, lotions, Creams & Ointments)NoneLukwago Mohammad4/15/2022
124143/GMP/2018 DRMipharm S.p.AVia B. Quaranta 12 – 20141, Milano ItalyItaly11/14/2016RT759268/8/20188/8/2021Non Beta LactamPowder for oral suspensionPowder for oral suspensionNoneDenis Mwesigwa8/8/2021
125IRF/F/072/05/2019 150/GMP/2019 Cert No.Mylan Laboratories LimitedPlot No. 1606-1609, GIDC, sarigam, Tal - Umergam, Dist Valsad-396155, IndiaIndiaG/25/1476 and G/28/1072 valid from 04/11/2016 to 03/11/2021 issued by Foods Drugs Control Administration Gujarat5/5/2017RT622422/1/20192/1/2022Non ?-lactamNon ?-lactam: • Coated & Uncoated Tablets (Oral contraceptives, placebos and ferrous fumarate)Non ?-lactam: • Coated & Uncoated Tablets (Oral contraceptives, placebos and ferrous fumarate)NoneWilberforce Kwiringira2/1/2022
126IRF/F/099/07/2019 102/GMP/2019 GMP Cert dateMylan Laboratories Limited, Beta Lactam Division (BLD)Plot No. 152/6 & 154/16, Doresanipalya, Bilekahalli, Opp. to IIM, Bannerghatta Road, Bangolore- 560076, IndiaIndia10/2/2018RT1019303/29/2019Beta-lactam (Penicillin)Beta-lactam (Penicillin): Powder for injectionBeta-lactam (Penicillin): Powder for injectionNoneZaidi Mwondha3/29/2022
127IRF/F/364/08/2018 R12 130/GMP/2018Mylan Laboratories LtdF/4 & F/12 MIDC Malegaon, Sinnar Nashik -422 113, IndiaIndiaForm-25-NKD/89 and Form 28-NKD/43 Valid up to 03/08/20209/19/2017RT877028/3/2018Non beta-lactam.Non beta-lactam. • Tablets • Capsules (Hard Gelatin)Non beta-lactam. • Tablets • Capsules (Hard Gelatin)NONEZaid Mwonda8/3/2021
128IRF/F/402/09/2018 R12 153/GMP/2018 GMP CERT NoMylan Laboratories LtdPlot no. S-16& S-17/A SEG Green Industrial Park Paepally (V) Jadchelra Telangana District- 509302 IndiaIndiaForm-25-30/MN/AP/2010/F/CC and Form 28-15/MN/AP/2012/FCC issued by Joint Director Drugs control Administration Government of Andra Pradesh Hyderabad-500 038 valid up to August 20239/19/2016740578/7/2018Non-beta lactamNon-beta lactam • Hard gelatin Capsules • TabletsNon-beta lactam; • Hard gelatin Capsules • TabletsNoneZaid Mwonda8/7/2021
129IRF/F/368/09/2018 R12 004/GMP/2019 GMP Cert No.Nabros Pharma Pvt LtdSurvey No. 110/A/2, Amit Farm Jain Upasraya, near Cocacola Factory, NH No. 8, Kajipura, Dist. Kheda-387411, Gujarat, IndiaIndiaG/1559 & G/1127 Valid until 04/06/202112/8/2015RT670747/24/20187/24/2021Non Beta lactamNon Beta lactam: • Tablets (coated and uncoated) • Hard gelatin capsules • Powders in sachets • Small volume parenteral and Ophthalmic preparations • External Preparations (gels)Non Beta lactam: • Tablets (coated and uncoated) • Hard gelatin capsules • Powders in sachets • Small volume parenteral and Ophthalmic preparations • External Preparations (gels)NoneAtumanya Amos7/24/2021
130IRF/F/092/07/2019 146/GMP/2019 Cert No.NATCO Pharma LimitedVijayapuri North, Nagarjuna Sagar, Peddavura Mandal, Nalgonda District- 508 202, Telangana - IndiaIndia102/NG/AP/98/F/R valid up to 31/12/20214/18/2018RT953695/7/20195/7/2022Beta-Lactam (Penicillin)Beta-Lactam (Penicillin): Aseptically filled sterile dry powder for injection.Beta-Lactam (Penicillin): Aseptically filled sterile dry powder for injection.NoneVictoria Kwesiga5/7/2022
131IRF/F/430/11/2018 187/GMP/2018 GMP Cert No.National Pharmaceutical Industries Company OmanP O Box 120 Postal Code 124, Road no.15 Rusayl Industrial Area, Sultanate of Oman.Oman1368 valid up to 17/04/2022 issued by the Ministry of Health, Sultanate of Oman for tablet, hard gelatin capsules, oral liquids and beta lactam11/27/2017RT8999610/3/2018Non-beta lactam Beta-LactamNon-beta lactam: • Hard gelatin Capsules • Tablets • Oral liquids for human use • ORS Beta-Lactam: • Tablets • Hard gelatin capsules • Dry powders for oral suspensionsNon-beta lactam: • Hard gelatin Capsules • Tablets • Oral liquids for human use • ORS Beta-Lactam: • Tablets • Hard gelatin capsules • Dry powders for oral suspensionsNoneZaid Mwonda10/3/2021
132IRF/F/387/09/2018 R12 179/GMP/2018 GMP Cert NoNem Laboratories Pvt. LtdPlot No. 133, Krishna Industrial Estate, Navghar Vasai (East), 401210 Dist. Thane (Zone 3), Maharashtra State, IndiaIndiaNo. 25-KD/1005 and 28-KD/793 renewed on 08/02/2017 and valid up to February 20211/2/2018RT912077/17/20187/17/2021Non Beta LactamNon Beta Lactam • Tablets (coated and uncoated) • Creams and Ointments (External Preparations) • Sterile Ophthalmic OintmentsNon Beta Lactam • Tablets (coated and uncoated) • Creams and Ointments (External Preparations) • Sterile Ophthalmic OintmentsNoneNasser Lubowa7/17/2021
133IRF/F/367/09/2018 R12 054/GMP/2019 GMP Cert No.Next Wave (India)Rampur Ghat, Road, Paonta Sahib, Distt. Sirmour- 173025, Himachal Pradesh, IndiaIndiaMB/06/336 & MNB/06/335 Valid until MAY 202111/27/2017RT699927/27/2018Non Beta lactamNon Beta lactam • Tablets (coated and uncoated), • Hard Gelatin Capsules, • Oral Liquids, • Semi-solids (Creams, gels & Ointments)Non Beta lactam • Tablets (coated and uncoated), • Hard Gelatin Capsules, • Oral Liquids, • Semi-solids (Creams, gels & Ointments)NoneAtumanya Amos7/27/2021
134IRF/F/382/09/2018 R12 057/GMP/2019 GMP Cert No.Nkunzi Pharmaceuticals (PTY) Ltd259 Davidson Road, Cnr Peddie Street, Wadville Ext. 1, Germinston 1422, South AfricaSouth Africa0000000234 issued by Medicines Control Council Validity from 22/09/2014 to 22/09/20193/22/2017RT808558/21/2018Non Beta lactamNon Beta lactam: • Tablets (Coated and uncoated) • Primary and secondary packaging of imported bulk tablets • Nasal spray/drops/metered dose sprayNon Beta lactam: • Tablets (Coated and uncoated) • Primary and secondary packaging of imported bulk tablets • Nasal spray/drops/metered dose sprayNoneKaleebu Frank8/21/2021
135IRF/F/009/01/2019 072/GMP/2019 GMP Cert No.Nobel Ilac Sanayii. ve Ticaret. A.S.Sancklar 8110 Duzce , TurkeyTurkey2001/13,valid for 3 years4/27/2018RT9567410/26/201812/20/2021Non-Beta LactamNon-Beta Lactam • Solid dosage forms (Tablets, Hard gelatin capsules) • Oral liquids • Topical semi-solid preparations (creams, ointments)Non-Beta Lactam • Solid dosage forms (Tablets, Hard gelatin capsules) • Oral liquids • Topical semi-solid preparations (creams, ointments)NoneAmoreen Naluyima12/20/2021
136169/GMP/2018 DR2Novo Nordisk A/S, Novo AlleDK 2880, Bagsvaerd DenmarkDenmark2/20/2017RT7984310/25/201810/25/2021Non-Beta LactamNon-Beta Lactam Biologicals Insulin (Small Volume Liquids)Non-Beta Lactam Biologicals Insulin (Small Volume Liquids)NoneKaleebu Frank10/25/2021
137169/GMP/2018 DRNovo Nordisk Production S.A.S5, avenue d’Orleans 28000 Chartres, FranceFrance9/21/2018RT10144110/30/201810/30/2021Non-Beta LactamNon-Beta Lactam Insulin (Vials) Insulin (Pre-filled syringes)Non-Beta Lactam Insulin (Vials) Insulin (Pre-filled syringes)NoneKaleebu Frank10/30/2021
138067/GMP/2019 DRPfizer Ireland Pharmaceuticals Grange Castle.Grange Castle busness park, Clondalkin Dublin 22 - IrelandIreland6/22/2017RT841494/1/20194/1/2022VaccinesVaccines: Prefilled syringesVaccines: Prefilled syringesNoneOnen Solomon L.4/1/2022
139068/GMP/2019 DRPfizer Pharmaceuticals LLCVega Baja Puerto Rico – United States of AmericaUnited States Of America6/22/2017RT841484/1/20194/1/2022Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneOnen Solomon L.4/1/2022
140IRF/F/086/06/2019 139/GMP/2019 Cert No.Pharma International CompanyAl- Qastal area, Airport Road, P.O.Box 334 Al Jubaiha, 11941, Amman- JordanJordan2\16\27\ 436746/27/2018RT975464/23/20194/23/2022Non-Beta Lactam Beta lactam (Cephalosporin)Non-Beta Lactam Tablets Liquids for internal use Semi-solids (creams, ointments, gels) Powders for Oral Suspensions Beta lactam (Cephalosporin): Powders for oral suspensions Tablets Hard gelatin capsules Sterile powders for InjectionNon-Beta Lactam Tablets Liquids for internal use Semi-solids (creams, ointments, gels) Powders for Oral Suspensions Beta lactam (Cephalosporin): Powders for oral suspensions Tablets Hard gelatin capsules Sterile powders for InjectionNoneKaleebu Frank4/23/2022
141IRF/F/004/01/2019 005/GMP/2019 GMP Cert No.Pierre Fabre Medicament production - Aquitaine Pharm International Site 1Avenue du Béarn - 64320 IDRON-FranceFranceM14/5264/4/2018RT9466410/16/201810/16/2021Non-beta lactamNon-beta lactam: • SVP liquids (packed in vials & Prefilled syringes). • SVP lyophilized powders(vials)Non-beta lactam: • SVP liquids (packed in vials & Prefilled syringes). • SVP lyophilized powders(vials)NoneEtuko Daniel10/16/2021
142IRF/F/429/11/2018 124/GMP/2019 Cert No.PIL Pharmaceuticals LimitedPlot No. 71 & 72, Sector-6A, Sidcul, Haridwar -249403 Uttarakhand, India.India56/UA/SC/P-2018 on Form 28, valid up to 22nd April, 20235/9/2018RT95970/RT933289/15/20189/15/2021Oral solid dosage PenicillinOral solid dosage Penicillin: • Tablets (coated and uncoated) • Hard gelatin capsules • Powder for oral suspension (Dry syrup)Oral solid dosage Penicillin: • Tablets (coated and uncoated) • Hard gelatin capsules • Powder for oral suspension (Dry syrup)NoneSsali Peter9/15/2021
143141/GMP/2018 DRPinewood Laboratories LtdBally Macarbry, Clonmel Co. Tipperary, IrelandIreland11/13/2017RT89464/RT89465/9/7/20189/7/2021Non Beta LactamOral liquids (syrups, suspensions, solutions) External liquids (shampoo, lotions) Semisolids (Creams, Ointments, Gels) & EnemasOral liquids (syrups, suspensions, solutions) External liquids (shampoo, lotions) Semisolids (Creams, Ointments, Gels) & EnemasNoneDenis Mwesigwa9/7/2021
144IRF/F/080/05/2019 GMP Cert No. 050/GMP/2020Pinnacle Life Science Pvt. LimitedKhasra No. 1328-1330, Village Manpura, Tehsil Baddi, Dist. Solan, Himachal Pradesh- 174101, IndiaIndiaMNB/08/719 and MNB/08/730 valid up to 19th March 2019, issued by the Health and Family welfare department- Himachal Pradesh12/5/2018RT1040142/19/20192/19/2022Non-Beta LactamNon-Beta Lactam: • Tablets (coated and uncoated) • Oral liquids • Hard gelatin capsules • Topical semi-solid preparations (creams, ointments, gels)Non-Beta Lactam: • Tablets (coated and uncoated) • Oral liquids • Hard gelatin capsules • Topical semi-solid preparations (creams, ointments, gels)NoneOkello Andrew2/19/2022
145IRF/F/370/09/2018 R12 132/GMP/2018Piramal Enterprises LtdSy. Nos 7-70, 70/1 and 70/2, Digwal Village, Kohir Mandal, Medak District, Telangana, IndiaIndia220/AP/MD/96/B&F/R valid till 16.03.20226/20/2016RT717247/31/2018Non beta-lactam.Non beta-lactam. • Manufacture and Packaging of liquid anaestheticsNon beta-lactam. • Manufacture and Packaging of liquid anaestheticsNoneAtumanya Amos7/31/2021
146IRF/F/428/11/2018 123/GMP/2019 Cert No.Psychotropics India LtdPlot No. 46 & 49, Sector 6A, IIE, SIIDCUL, Haridwar -249403, Uttrakhand, IndiaIndia41/UA/SC/P-2006 on Form 28, valid up to 02nd June, 20215/9/2018RT959699/18/20189/18/2021Non beta lactamNon beta lactam: • Tablets (coated and uncoated) • Oral liquids • Creams, ointments and lotionsNon beta lactam: • Tablets (coated and uncoated) • Oral liquids • Creams, ointments and lotionsNoneSsali Peter9/18/2021
147IRF/F/032/02/2019 111/GMP/2019 GMP Cert No.Pulse Pharmaceuticals Pvt LimitedPlot no. 400, 407, 409 Kharondi, Roorkee 247667, Uttarakhand, IndiaIndia80/UA/2007 valid from 10-07-2017 to 09/07/202011/2/2017RT8477811/16/201811/16/2021Non-beta LactamNon-beta Lactam: • Tablets (coated and uncoated) • Hard gelatin capsulesNon-beta Lactam: • Tablets (coated and uncoated) • Hard gelatin capsulesNoneAtumanya Amos11/16/2021
148IRF/F/058/03/2019 148/GMP/2019 Cert No.Ra Chem Pharma LimitedPlot No. A-19/C, Road No.18 IDA Nacharam, Hyderabad – 76 Telangana state, India.India23/RR/AP/2007/F/R as per Form 25 Renewed on 07/07/2013, Valid to 6/7/202310/17/2017RT8867011/23/201811/23/2021Non-Beta LactamNon-Beta Lactam • Tablets (Coated and Uncoated) • Hard Gelatin Capsules • PelletsNon-Beta Lactam • Tablets (Coated and Uncoated) • Hard Gelatin Capsules • PelletsNoneNasser Lubowa11/23/2021
149IRF/F/069/05/2019 181/GMP/2019 Cert No.Raptakos Brett and Company Limited100/2 M.I.D.C. Dhatav, Roha 402 116 Maharashtra IndiaIndiaForm 28 KD/268 valid up to 31/12/20217/18/2016RT725791/22/20191/22/2022Non-beta lactamNon-beta lactam: • Hard Gelatin CapsulesNon-beta lactam: • Hard Gelatin CapsulesNoneWilberforce Kwiringira1/22/2022
150IRF/F/018/02/2019 073/GMP/2019 GMP Cert No.Recipharm Pharmaservices Pvt. Limited34th KM, Tumkur Road, T. Begur, Nelamangana, Bengaluru - 562123, India.IndiaKTK/25/460/2001 (Form 25) & KTK/28/321/2001 (Form 28) Valid to 28/02/20219/27/2017RT8801511/27/2018Non-Beta LactamNon-Beta Lactam: • Tablets (coated and uncoated)Non-Beta Lactam: • Tablets (coated and uncoated)NoneNasser Lubowa11/27/2021
151IRF/F/035/02/2019 073/GMP/2019 GMP Cert No.Recipharm Pharmaservices Pvt. Limited34th KM, Tumkur Road, T. Begur, Nelamangala, Bengaluru - 562123, India.IndiaKTK/25/460/2001 (Form 25) & KTK/28/321/2001 (Form 28) Valid to 28/02/20219/27/2017RT8801511/27/2018Non-beta LactamNon-beta Lactam: • Tablets (coated and uncoated)Non-beta Lactam: • Tablets (coated and uncoated)NoneNasser Lubowa11/27/2021
152IRF/F/395/09/2018 R12 065/GMP/2019 GMP Cert No.Remidex Pharma Pvt LtdB-249/250,Peenya Industries Estate 2nd Stage Peenya Bangalore-560058 India.IndiaKTK/25A/301/1995,dated 14.03.2016 Valid from 02.11.2015 to 01.11.20203/21/2017RT808208/17/2018Non beta-lactamNon beta-lactam • Tablets (coated)Non beta-lactam • Tablets (coated)NoneVictoria Kwesiga8/17/2021
153IRF/F/001/01/2019 072/GMP/2019 GMP Cert No.Rene Industries LimitedPlot 680, Kamuli Road, Kireka P.O. Box 6034, Kampala, UgandaUganda12/20/2018Beta lactam Non beta lactamBeta lactam • Hard gelatin capsules • Powders for oral suspension. • Tablets Non beta lactam • Tablets • Oral liquids • External preparations • Oral powders packed in sachets • Hard gelatin capsulesBeta lactam • Hard gelatin capsules • Powders for oral suspension. • Tablets Non beta lactam • Tablets • Oral liquids • External preparations • Oral powders packed in sachets • Hard gelatin capsulesNoneOnen Solomon L.12/20/2021
154003/GMP/2019 DRRoche Diagnostics Gmbh. MannheimSandhoffer Street 116, GermanyGermany12/5/2018RT1040851/3/20191/3/2022Non-Beta LactamNon-Beta Lactam: SVP Liquids in vials SVP Liquids in pre-filled syringes SVP LyophilisatesNon-Beta Lactam: SVP Liquids in vials SVP Liquids in pre-filled syringes SVP LyophilisatesNoneKaleebu Frank1/3/2022
155IRF/F/378/09/2018 R12 044/GMP/2019 GMP Cert No.Saga LaboratoriesSurvey No. 198/2 and 198/3, Chacharwadi Vasna Tal District - Sanad Ahmedabad 380 015 Gujarat IndiaIndiaAuthorization number G/25/1877 & G/28/1330 valid till 18/03/20207/6/2018RT99173, RT99174, RT991858/3/2018Beta lactam (Cephalosporin) Non-beta LactamBeta lactam (Cephalosporin) • Tablets • Hard Gelatine capsules • Powders for oral suspension Non-beta Lactam • Tablets • Hard Gelatine Capsules • Powders for oral suspensionBeta lactam (Cephalosporin) • Tablets • Hard Gelatine capsules • Powders for oral suspension Non-beta Lactam • Tablets • Hard Gelatine Capsules • Powders for oral suspensionNoneEtuko Daniel8/3/2021
156166/GMP/2018 DRSandoz S.R.L. Targu-Mures SiteSandoz S.R.L. Str. Livezeni nr. 7a 540472 Targu-Mures RomaniaRomania5/24/2018RT9588010/30/201810/30/2021Non-Beta LactamNon-Beta Lactam Hard Gelatin Capsules Tablets (Coated and Uncoated) Powders (Granules for Oral Suspension)Non-Beta Lactam Hard Gelatin Capsules Tablets (Coated and Uncoated) Powders (Granules for Oral Suspension)NoneDenis Mwesigwa10/30/2021
157IRF/F/038/02/2019 166/GMP/2019 Cert No.Sanjar Pharmaceuticals LimitedSurvey No. 622/2/1/4, Dedhrota, Ta- Himatnagar, dist Sabarkantha, Gujarat, IndiaIndiaForm 28 G/28/1577 Validity: till 13/07/202111/28/2017RT897839/12/20199/12/2022Non-beta LactamNon-beta Lactam: • General liquid injections - Ampoules and vials • Dry powder for injectionNon-beta Lactam: • General liquid injections - Ampoules and vials • Dry powder for injectionNoneAnnet Ssekindu9/12/2022
158139/GMP/2018 DRSanofi Aventis, S.ACtra. C-35 (La Batlloria- Hostalric, Km. 63,09) Riells i Viabrea, Gerona, 17404, SpainSpain5/17/2018RT962209/7/20189/7/2021Non Beta LactamTabletTabletNoneDenis Mwesigwa9/7/2021
159061/GMP/2019 DRSanofi Winthdrop Industrie1 rue de la vierge, FranceFrance8/10/2018RT720763/14/20193/14/2022Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNone3/14/2022
160IRF/F/074/05/2019 138/GMP/2019 GMP Cert No.Scott-Edil Pharmacia Ltd (Unit I)56, EPIP, Phase-1, Jharmajri, Baddi, Distt. Solan, (H.P), IndiaIndiaMB/05/139 valid till 29-05-2020 MNB/05/138 valid till 29-05-202011/20/2017RT8971911/27/201811/27/2021Non-Beta LactamNon-Beta Lactam: • Tablets • Hard gelatin capsules • Oral liquids • External creams, ointments • Sterile eye drops and nasals • SVP-solutions • SVP-powdersNon-Beta Lactam: • Tablets • Hard gelatin capsules • Oral liquids • External creams, ointments • Sterile eye drops and nasals • SVP-solutions • SVP-powdersNoneOnen Solomon L.11/27/2021
161IRF/F/384/09/2018 R12 073/GMP/2019 GMP Cert No.Shin Poong Pharma. Co., Ltd70, Sandan-ro,19beon-gil, Danwon-gu, Ansan-si, Gyeonggi-do, South Korea.Korea, Republic of (South)3 dated 09/11/2000 (open validity)3/13/2018RT941308/14/2018Non Beta lactamNon Beta lactam • Tablets (coated and uncoated) • Oral granules (sachets)Non Beta lactam • Tablets (coated and uncoated) • Oral granules (sachets)NoneOnen Solomon L.8/14/2021
162IRF/F/376/09/2018 R12 136/GMP/2018Sirmaxo Chemicals Pvt LtdPlot E-35 MIDC Tarapur District :Palghar Thane MaharashtraIndia25 ( KD-523)1/25/2016RT683168/3/2018Non beta-lactam Disinfectants and antisepticsNon beta-lactam Disinfectants and antiseptics • Solutions • Emulsions • GelsNon beta-lactam Disinfectants and antiseptics • Solutions • Emulsions • GelsNoneOkello Andrew8/3/2021
163199/GMP/2018 DRSofarimex Idustria Quimica e Farmaceutica SAAvenida das Industrias, Alto do Colaride Aguaviva, PortugalPortugal5/8/2018RT9594411/30/201811/30/2021Non-Beta LactamNon-Beta Lactam Hard-Gelatin Capsules Semi-solids TabletsNon-Beta Lactam Hard-Gelatin Capsules Semi-solids TabletsNoneKaleebu Frank11/30/2021
164IRF/F/380/09/2018 R12 008/GMP/2019 GMP Cert No.Sparsh Bio-Tech Pvt. LtdPlot No. 1, Survey No.242/243/244, Lakhabavad, Jamnagar Gujarat- 361006, IndiaIndiaAuthorization number G/1174 valid till 22/07/20181/29/2018RT921067/31/20187/31/2021Beta lactam (Penicillin)Beta lactam (Penicillin) • Tablets • Hard Gelatin capsules • Powders for oral suspensionBeta lactam (Penicillin) • Tablets • Hard Gelatin capsules • Powders for oral suspensionNoneEtuko Daniel7/31/2021
165IRF/F/409/10/2018 156/GMP/2018 GMP Cert No.Square Pharmaceuticals LimitedDhaka Unit Kaliakoir Gazipur, 1750 BangladeshBangladesh460 & 235 Valid till 18.04.197/17/2018RT858639/27/20189/27/2021Beta Lactam preparations (Cephalosporins) Non-beta lactam preparationsTablets Capsules Powders for oral suspension SVP powders for injection Eye/Ear drops Nasal drops Nebulizer solutions Insulin (Vials and Cartridges) Preparations in Prefilled Syringes Metered Dose InhalersTablets Capsules Powders for oral suspension SVP powders for injection Eye/Ear drops Nasal drops Nebulizer solutions Insulin (Vials and Cartridges) Preparations in Prefilled Syringes Metered Dose InhalersNone9/27/2021
166IRF/F/024/02/2019 085/GMP/2019 GMP Cert No.Stanford Laboratories Pvt. Limited8 Industrial area, Mehatpur- 174315, Himachal Pradesh- IndiaIndiaLicense number MNB/08/695 and MNB/08/696 (Form 25 and 28) issued by the Department of Health and Family Welfare, Himachal Pradesh, valid till 19th January 2020.11/21/2016RT7621712/13/201812/13/2021Non-beta LactamNon-beta Lactam • Tablets (coated and uncoated) • Hard gelatin capsules • Oral powder in sachetsNon-beta Lactam • Tablets (coated and uncoated) • Hard gelatin capsules • Oral powder in sachetsNoneNambasa Victoria12/13/2021
167IRF/F/111/07/2019 180/GMP/2019 Cert No.Strides Pharma Science Limited (Strides Shasun)KRS Gardens, Plot 36/7 Suragajkkanahalli, Indlawadi cross, Ankal Taluk, Bangalore South - 562106, IndiaIndiaKTK/25/415/98; KTK/28/301/98 ; KTK/25F/2/20095/7/2018RT958875/7/20195/7/2022Non-beta lactamNon-beta lactam: Tablets Hard Gelatin Capsules Soft Gelatin Capsules Oral Powders in Sachets Liquids for internal use Topical creams / ointments / gelsNon-beta lactam: Tablets Hard Gelatin Capsules Soft Gelatin Capsules Oral Powders in Sachets Liquids for internal use Topical creams / ointments / gelsNoneNasser Lubowa5/7/2022
168IRF/F/046/02/2019 155/GMP/2019 GMP Cert No.Sun Pharmaceutical Industries LimitedB-2 Madkai Industrial Estate Madkai Ponda-Goa-403404 IndiaIndia312 and 313 valid up to 2021 issued by FDA-Goa6/22/2018RT95040/RT9504112/7/201812/7/2021Non-beta lactamNon-beta lactam • Tablets (coated and uncoated) • Semi solid (Ointments creams and gels) - steroid and non-steroidNon-beta lactam • Tablets (coated and uncoated) • Semi solid (Ointments creams and gels) - steroid and non-steroidNoneZaid Mwonda12/7/2021
169IRF/F/109/07/2019 109/GMP/2019 GMP Cert No.Sun Pharmaceutical Industries LimitedIndustrial Area 3, A.B. Road, Dewas 455001, Madhya Pradesh, IndiaIndia25/24/83 valid from 09/03/2015 to 08/03/202012/21/2018RT1047125/10/20195/10/2022Penem Beta lactam (Penicillin and Cephalosporin) Non-beta lactamPenem: Small volume powders (aseptically filled). Beta lactam (Penicillin and Cephalosporin): Tablets, Capsules, Powders for Oral Suspensions. Non-beta lactam: Tablets, Capsules, Powders for Oral SuspensionsPenem: Small volume powders (aseptically filled). Beta lactam (Penicillin and Cephalosporin): Tablets, Capsules, Powders for Oral Suspensions. Non-beta lactam: Tablets, Capsules, Powders for Oral SuspensionsNoneVictoria Kwesiga5/10/2022
170IRF/F/405/10/2018 R12 181/GMP/2018 GMP Cert NoSwiss Parenterals ltd-Unit I808,809 & 810 Kerala Industrial Estate, GIDC, 382 220 Gujarat- IndiaIndiaForm 28: G/28/1078; Validity 03/03/20222/13/2018RT931438/28/20188/28/2021Penicillin parenteral formulations Non-beta lactam parenteral formulationsPenicillin SVP (Dry powders for inj; excluding diluents and adjuncts). Non-beta lactam SVP (liquids for inj in ampoules, vials). SVP (dry powder for inj in vials; excluding diluents and adjuncts). Sterile Ophthalmic and ear prepns.Penicillin SVP (Dry powders for inj; excluding diluents and adjuncts). Non-beta lactam SVP (liquids for inj in ampoules, vials). SVP (dry powder for inj in vials; excluding diluents and adjuncts). Sterile Ophthalmic and ear prepns.NoneDennis Mwesigwa8/28/2021
171IRF/F/406/10/2018 R12 182/GMP/2018 GMP Cert NoSwiss Parenterals ltd-Unit II402, 412-414 Kerala Industrial Estate, GIDC, Gujarat- IndiaIndiaForm 28: G/28/1446; Validity 03/03/20222/13/2018RT931448/21/20188/21/2021Beta-Lactam CephalosporinBeta-Lactam Cephalosporin • SVP (Dry powder for injection)Beta-Lactam Cephalosporin • SVP (Dry powder for injection)NoneDenis Mwesigwa8/21/2021
172047/GMP/2019 DRTECHPharm GmbHDraisstr. 14 76646 BruschsalGermany2/13/2018RT847742/18/20192/18/2022Quality Control Testing Stability studiesQuality Control Testing Stability studiesQuality Control Testing Stability studiesNone2/18/2022
173IRF/F/357/08/2018 R12 100/GMP/2019 GMP Cert No.Tenth Of Ramadan for Pharmaceutical Industries and Diagnostic Reagents (Rameda).Second Industrial Zone Plot No. 5 Six of October City, EgyptEgyptSerial 00073/2017 Code No. FM-LPM-02 (Open validity)12/19/2017RT90780, RT90781,RT907827/10/20187/10/2021Non ?-lactam Penicillin CephalosporinsNon ?-lactam Ophthalmic line (Eye drops, SVP injection solution in Vials and water for injection – FFS) Oral liquid Dry powder filled in sachets. Oral Dry powder Tab Caps Penicillin Tab Caps Cephalosporins SVP powder sterileNon ?-lactam Ophthalmic line (Eye drops, SVP injection solution in Vials and water for injection – FFS) Oral liquid Dry powder filled in sachets. Oral Dry powder Tab Caps Penicillin Tab Caps Cephalosporins SVP powder sterileNoneKenneth Kiiza7/10/2021
174IRF/F/419/10/2018 207/GMP/2018 GMP Cert No.Troikaa Pharmaceuticals Limited - Thol PlantKadi Road Thol 382728 Dist Mehsana Gujarat - India.IndiaG/28-B/7, G/617 and G/357 all dated 27/06/2016 and all valid up to 26/06/20219/20/2016RT742009/18/20189/18/2021Non beta lactamNon beta lactam: • Small Volume liquids for injection (Ampoules & vials) • Powders for injection (vials) • Liquids for inhalation • Tablets • Liquids for external useNon beta lactam: • Small Volume liquids for injection (Ampoules & vials) • Powders for injection (vials) • Liquids for inhalation • Tablets • Liquids for external useNoneAtumanya Amos9/18/2021
175IRF/F/381/09/2018 R12Twenty First Century Pharmaceutical Pvt LtdKhasra No. 282, Nalheri Dehviran, Nalhera Anantpor, Puhana Iqbalpur Road, Roorkee 247668 Dist Haridwar Uttarakhand, IndiaIndia11/UA/SC/P-2010 valid till 17/02/20204/25/2017RT82064/RT820627/27/20187/27/2021Beta lactam (Cephalosporin) Beta lactam (Penicillins)Beta lactam (Cephalosporin) • Tablets • Dry Powders for oral suspension Beta lactam (Penicillins) • Tablets • Dry Powders for oral suspensionBeta lactam (Cephalosporin) • Tablets • Dry Powders for oral suspension Beta lactam (Penicillins) • Tablets • Dry Powders for oral suspensionNoneEtuko Daniel7/27/2021
176IRF/F/052/03/2019 GMP Cert No. 063/GMP/2019Unichem Laboratories LimitedPlot 15, 16, 17, 17A and 18 Pillerne Industrial Estate Pilerne Bardez Goa - 403115 India.India321 and 431 valid until 2021 issued by FDA -Goa6/2/2018RT9242112/14/2018Non-?eta LactamNon-?eta Lactam: • Tablets (coated and uncoated) • Hard gelatin capsulesNon-?eta Lactam: • Tablets (coated and uncoated) • Hard gelatin capsulesNoneZaid Mwonda12/14/2021
177IRF/F/029/02/2019 091/GMP/2019 Cert No.Unique Pharmaceutical LaboratoriesPlot No. 215-219 and 304-308, GIDC Industrial Estate Panoli-394116. Gujarat, Indiauganda02/RR/TS/2014/F/G valid up to 01/08/2019 G/1430 & G/1051 valid until 29/06/2021 for tablets and parenteral preparations respectively. G/11575 & G/1141 valid until 28/05/2021 for oral liquids and external creams and ointments respectively.6/6/2018RT9682412/11/201812/11/2021Non-beta LactamNon-beta Lactam: • Tablets (coated and uncoated) • LVP solutions • SVP solutions • Orals liquids • Creams and ointmentsNon-beta Lactam: • Tablets (coated and uncoated) • LVP solutions • SVP solutions • Orals liquids • Creams and ointmentsNoneOnen Solomon L.12/11/2021
178IRF/F/091/07/2019 101/GMP/2019 GM Cert No.Unique Pharmaceutical LaboratoriesPlot No. 4, GIDC Industrial Area Panoli-394116. Bharuch Gujarat, IndiaIndiaForm 25 G/25.2188 valid until 14/03/2022 Form 25A G/25A/4835 & G/1141 valid until 16/03/20226/6/2018RT968253/5/2019Non-Beta LactamNon-Beta Lactam: • Tablets (coated and uncoated) • LVP liquids • SVP liquids • Sterile Eye drops, Ear drops and sterile water for InjectionNon-Beta Lactam: • Tablets (coated and uncoated) • LVP liquids • SVP liquids • Sterile Eye drops, Ear drops and sterile water for InjectionNoneKenneth Kiiza3/5/2022
179IRF/F/082/05/2019 171/GMP/2019 Cert No.United Pharmaceuticals Manufacturing Limited CompanyAl-Rageem, Sahab, P.O.Box 69, Amman 11591- JordanJordan2-16-6-27853 valid up to 20209/27/2018RT101804, RT1018054/12/20194/12/2022Non-Beta LactamNon-Beta Lactam: Coated and Uncoated Tablets Hard Gelatin Capsules Liquids for internal use Soft gelatin capsules Dry powders for oral suspensions Semi solids (creams, gels, ointments) Topical solutions (liquids for external use) SuppositoriesNon-Beta Lactam: Coated and Uncoated Tablets Hard Gelatin Capsules Liquids for internal use Soft gelatin capsules Dry powders for oral suspensions Semi solids (creams, gels, ointments) Topical solutions (liquids for external use) SuppositoriesNoneKaleebu Frank4/12/2022
180IRF/F/040/02/2019 184/GMP/2019 Cert No.Venus Remedies LimitedHill Top Industrial Estate Tharmajiri EP.IP.Phase 1; Baddi; Himachal Pradesh, India.IndiaMB/05/205- ( 26) - validity : 11.10.2005 to 10.10.2020 MB/05/204 -( 28 )- validity ; 11.10.2005 to 10.10.20203/15/2017RT8062611/23/201811/23/2021Beta Lactam Cabapenems Beta Lactam Cephalosporin Non-Beta Lactam OncologyBL Cabapenems SVP Powders for injections. BL Cephalosporin SVP Powders for injections. NBL SVP Liquids (Prefilled syringes, Vials and Ampules) SVP Liquids and lyophilized Oncology SVP Liquids and lyophilized injectionsBL Cabapenems SVP Powders for injections. BL Cephalosporin SVP Powders for injections. NBL SVP Liquids (Prefilled syringes, Vials and Ampules) SVP Liquids and lyophilized Oncology SVP Liquids and lyophilized injectionsNoneAnnet Ssekindu11/23/2021
181021/GMP/2019 DRVet Pharma Friesoythe Gmbh, GermanyVet PharmaFriesoythe Gmbh, Seelsberger Street @-4, 26169, GermanyGermany4/19/2017RT817851/24/20191/24/2022Aseptically Prepared Teminally Sterilized Non-Beta LactamAseptically Prepared LVP Liquids SVP Liquids in vials Eye Drops Teminally Sterilized LVP Liquids SVP Liquids in vials Non-Beta Lactam Liquids for External Use Oral LiquidsAseptically Prepared LVP Liquids SVP Liquids in vials Eye Drops Teminally Sterilized LVP Liquids SVP Liquids in vials Non-Beta Lactam Liquids for External Use Oral LiquidsNoneKaleebu Frank1/24/2022
182IRF/F/081/05/2019 176/GMP/2019 Cert No.Veterinary and Agricultural Products Manufacturing Company Limited (VAPCO)Dhulail Province, King Hussein St. 120/Zarka- JordanJordan1/1975 Issued by JFDA Nov/2015 and valid for 3 years10/2/2018RT1019204/28/20194/28/2022Non-Beta Lactam Beta lactam (penicillin) EctoparasticidesNon-Beta Lactam: Tablets bolus Liquids for internal use Semi-solids Oral Powders in sachets and jars Small Volume liquids in vials Beta lactam (penicillin): Oral Powders in sachets and jars Ectoparasticides: Liquids for external useNon-Beta Lactam: Tablets bolus Liquids for internal use Semi-solids Oral Powders in sachets and jars Small Volume liquids in vials Beta lactam (penicillin): Oral Powders in sachets and jars Ectoparasticides: Liquids for external useNoneKaleebu Frank4/28/2022
183IRF/F/057/03/2019 134/GMP/2019 Cert No.Virchow Biotech Pvt. LimitedSurvey No 172 part, Gagillapur, Dundigal, Medchal District, Telangana- 500 043, IndiaIndiaForm 25: 30/RR/AP/2005/F/R Valid to 25/07/2020 Form 28: 51/RR/AP/2004/F/R valid to 19/11/20198/11/2017RT8587411/21/201811/21/2021Biologicals Non-Beta Lactam ActivitiesBiologicals Injectable Proteins Blood and sera Oral liquids-Probiotics Non-Beta Lactam SVP Solutions in Catridges, Syringes and Vials SVP Powders Creams and ointments Hard Gelatin Capsules TabletsBiologicals Injectable Proteins Blood and sera Oral liquids-Probiotics Non-Beta Lactam SVP Solutions in Catridges, Syringes and Vials SVP Powders Creams and ointments Hard Gelatin Capsules TabletsNoneNasser Lubowa11/21/2021
184IRF/F/100/07/2019 137/GMP/2019 Cert No.Wallace Pharmaceuticals Pvt LimitedBhatian, Nalagarh, Dist. Solan HP 174101, IndiaIndiaMNB/07/501 and MB/07/502 dated 17/04/2007 from State Drug Controller (HP) Valid up to 16/04/20227/4/2017RT847464/9/20194/9/2022Non-Beta lactamNon-Beta lactam: Tablet, Dry powder for oral suspension, Oral solution (Syrup)Non-Beta lactam: Tablet, Dry powder for oral suspension, Oral solution (Syrup)NoneZaidi Mwondha4/9/2022
185IRF/F/022/02/2019 119/GMP/2019 Cert No.Win-Medicare Private LimitedPlot Meerut Muzaffarnager Road, Modipuram- 250 110 Uttar Pradesh, India.India14 of 1983 Form 25 and 10/SC/P of 1984 on Form 28 (Dt: 20/11/2017), valid up to 31st January, 2022.2/19/2018RT9333411/23/201811/23/2021Non-beta LactamNon-beta Lactam • Tablets (coated and uncoated) • Hard Gelatin Capsules • SVP Liquids: Ampoules • Powders/granules in sachetsNon-beta Lactam • Tablets (coated and uncoated) • Hard Gelatin Capsules • SVP Liquids: Ampoules • Powders/granules in sachetsNoneOkello Andrew11/23/2021
186IRF/F/098/07/2019 133/GMP/2019 Cert No.Wockhardt LimitedBiotech Park, H-14/2, MIDC., Waluj, Aurangabad-431136 Maharashtra IndiaIndiaForm 28D –AD/004 State and Drugs Administration Aurangabad Division MH State India. Valid up to up to 07/04/20238/7/2018RT1000934/26/20194/26/2022Biological productsBiological products: • Small volume parenterals (vials, cartridges and pre-filled syringes)Biological products: • Small volume parenterals (vials, cartridges and pre-filled syringes)NoneAtumanya Amos4/26/2022
187076/GMP/2019 DRYuria Pharm LLC Manufacturing Site No. 1108, Kobzarska street, Cherkasy, 18030 - UkraineUkraine4/30/2019RT1103085/16/20195/16/2022Non-Beta LactamNon-Beta Lactam: LVP Liquids SVP Liquids in Vials Oral LiquidsNon-Beta Lactam: LVP Liquids SVP Liquids in Vials Oral LiquidsNoneKaleebu Frank5/16/2022
188IRF/F/389/09/2018 R12 205/GMP/2018Zeiss Pharmaceuticals Pvt. LtdPlot No. 72, EPIP I, Jharmajiri, Baddi Himachal Pradesh- IndiaIndiaMNB/05/107 and MB/05/108 (Form 26) valid till 30th April 2019 and MB/05/233 valid to 04/12/20203/16/2017RT806477/24/20187/24/2021Beta Lactam (Cephalosporin) Beta Lactam (Carbapenems)Beta Lactam (Cephalosporin) • SVP Powders Vials Beta Lactam (Carbapenems) • SVP Powders VialsBeta Lactam (Cephalosporin) • SVP Powders Vials Beta Lactam (Carbapenems) • SVP Powders VialsNoneNasser Lubowa7/24/2021
189036/GMP/2019 DRZoetis2000 Rockford Road, Charles City, lowa 50616-9101, United States of America.United States Of America6/30/2017RT847212/4/20192/4/2022Vaccines BiologicalsVaccines Small Volume Parenterals Biologicals Small Volume ParenteralsVaccines Small Volume Parenterals Biologicals Small Volume ParenteralsNone2/4/2022
190IRF/F/007/01/2019 013/GMP/2019 GMp Cert No.Zoetis Belgium SARue Laid Burniat 1, Louvain-La-Neuve, 1348, BelgiumBelgium419 V dates 2017-02-056/30/2017RT8472810/19/2018Non-beta lactam Biologicals & VaccinesNon-beta lactam: • SVP liquids packed in vials and prefilled syringes. • SVP lyophilized powders packed in vials. Biologicals & Vaccines: • SVP liquids packed in vials and prefilled syringes. • SVP lyophilized powders packed in vials.Non-beta lactam: • SVP liquids packed in vials and prefilled syringes. • SVP lyophilized powders packed in vials. Biologicals & Vaccines: • SVP liquids packed in vials and prefilled syringes. • SVP lyophilized powders packed in vials.NoneEtuko Daniel10/19/2021
191IRF/F/431/11/2018 059/GMP/2019 GMP Cert No.Zoetis Industria De Produtos Veterinarios LtdaRua Luiz Fernando Rodriguez 1701-Campinas-Sao Paulo-Brazil.BrazilSP 000072-8 Validity 02/03/20197/5/2017RT8472510/2/2018Immunological productsImmunological products: • Vaccines (Veterinary)Immunological products: • Vaccines (Veterinary)NoneMutyaba Michael10/2/2021
192IRF/F/094/07/2019 141/GMP/2019 Cert No.Zota Healthcare LimitedPlot No 169 ,Surat special Economic Zone,Nr Sachin Railway station,Sachin Surat -394230.Gujarat-IndiaIndiaG/25/1905 and G/28/1360 valid till 7/12/2020 Issued by the Food and Drug control Administration Gujarat India12/19/2018RT1045974/30/20194/30/2022Non ?-lactamNon ?-lactam: Tablets (Coated and uncoated) Capsules (Hard gelatin)Non ?-lactam: Tablets (Coated and uncoated) Capsules (Hard gelatin)NoneNasser Lubowa4/30/2022
193IRF/F/093/07/2019 116/GMP/2019 Cert No.Zydus Health Care LimitedSurvey No. 49/3, 51/1, 51/2 Ringanwada Village, Daman (U.T) IndiaIndiaDD/616&DD617 valid up to 09/12/20194/5/2018RT947085/3/20195/3/2022Beta-Lactam (Cephalosporin)Beta-Lactam (Cephalosporin): Sterile Powder for injection (Aseptically filled)Beta-Lactam (Cephalosporin): Sterile Powder for injection (Aseptically filled)NoneVictoria Kwesiga5/3/2022
194IRF/F/112/08/2019 GMP Cert No. 015/GMP/2020Eugia Pharma Specialities LimitedPlot 5-38 Sy. No. 550, 551 & 552 Near Genome valley, Kolthur village, Shemeerpet Mandal, Malkajgir District, Telangana, India 500078India24/RR/TS/2015/F/G Valid till 02/02.2020 issued by Government of Telangana, Hyderabad, India5/7/2018RT958975/3/20195/3/2022Oncology, HormonesOncology: Tablets, Capsules (hard gelatin), Capsules (soft gelatin), SVP liquids in Vials and Prefilled Syringes-Aseptically produced, SVP liquids in Vials and prefilled Syringes-Terminally sterilized, SVP Powders-Lyophilized Hormones: Capsules (soft gelatin), SVP liquids in Vials and prefilled Syringes Aseptically producedOncology: Tablets, Capsules (hard gelatin), Capsules (soft gelatin), SVP liquids in Vials and Prefilled Syringes-Aseptically produced, SVP liquids in Vials and prefilled Syringes-Terminally sterilized, SVP Powders-Lyophilized Hormones: Capsules (soft gelatin), SVP liquids in Vials and prefilled Syringes Aseptically producedNoneMr. Lubowa Nasser5/3/2022
195IRF/F/114/08/2019 114/GMP/2019 Cert No.Medreich Limited (Unit 7)Survey No. 11,12,13,14 and 15, Poojaramanahalli Village, Hoskote Taluk, Bangalore Rural district-562114, IndiaIndiaKTK/25/634/2015 and KTK/28/426/2015 dated 06/05/2015 from Drug Controller & Licensing Authority (Karnataka state) Valid up to 05/05/20204/18/2018RT953684/2/20194/2/2022Non beta-lactamNon beta-lactam: Tablets, Capsules (hard gelatine)Non beta-lactam: Tablets, Capsules (hard gelatine)NoneZaidi Mwondha4/2/2022
196IRF/F/115/08/2019 115/GMP/2019 GMP Cert No.Mylan Laboratories Limited, AhmedabadPlot No.20 & 21,Pharmez, Pharmaceutical Special Economic Zone, Sharkej Bavla, National High Road No.8A, Near Village Matoda, Taluka: Sanand, Dist.: Ahmedabad- 382213, IndiaIndiaG/25/1842 valid from 04/11/2016 to 03/11/2021 G/28/1297 valid from 04/11/2016 to 03/11/201910/15/2018RT1022583/26/20193/26/2022Hormones, Non-Beta lactamHormones: Tablet, Small Volume Parenteral solutions in glass vials terminally sterilized Non-Beta lactam: TabletHormones: Tablet, Small Volume Parenteral solutions in glass vials terminally sterilized Non-Beta lactam: TabletNoneZaidi Mwondha3/26/2022
197IRF/F/116/08/2019 140/GMP/2019 GMP Cert No.Akums Drugs and Pharmaceuticals Limited - Plant IIPlant II, Plot No. 22, Sector- 6A, IIE, SIDCUL, Ranipur, Haridwar -249403 Uttarakhand IndiaIndia129/UA/SC/P-2007 on form 28 and 123/UA/2007 on form 25 both valid up to 20228/31/2018RT1009616/28/20196/28/2022Non-beta Lactam (Human)Non-beta Lactam (Human): Oral liquidsNon-beta Lactam (Human): Oral liquidsNoneNakimuli Eunice Lukakamwa6/28/2022
198IRF/F/117/08/2019 177/GMP/2019 Cert No.Rusan Pharma Limited - Unit IIShed No. 383 AS-I, Sector IV Kasez Gandhidham Kutch, 370 230 India IndiaG/25/2156 on form 25 validity 31/05/2016 to 30/05/202110/24/2018RT102579, RT1018966/21/20196/21/2022Non-beta LactamNon-beta Lactam: Transdermal PatchesNon-beta Lactam: Transdermal PatchesNoneNakimuli Eunice Lukakamwa6/21/2022
199IRF/F/118/08/2019 168/GMP/2019 GMP CertSai Mirra Innopharm Pvt. Limited288 & 299 Sidco Estate, Ambattur, Chennai-600098. IndiaIndiaForm 28 License No. 92, Form 26 valid 31/12/20218/13/2018RT871475/17/20195/17/2022Non-beta lactam (Human)Non-beta lactam (Human): Tablets, Hard Gelatin Capsules, Liquids for internal use, Granules in Sachet Non-beta lactam (Human): Tablets, Hard Gelatin Capsules, Liquids for internal use, Granules in Sachet NoneFarida Khaukha5/17/2022
200IRF/F/119/08/2019 065/GMP/2020 GMP Cert No.Aurolab - IndiaNo. 1, Sivagangai main road, Veerapanjan, Madurai-625020, Tamil Nadu- IndiaIndiaLicence no. TN00002387 (in form 28) valid until 10th December 2022, issued by the Director of Drugs Control- Tamil Nadu, India8/28/2018RT1007616/21/20196/21/2022Non-beta lactamNon-beta lactam: Aseptically filled Ophthalmic liquids, Lyophilised Ophthalmic powders, Terminally sterilized Ophthalmic liquidsNon-beta lactam: Aseptically filled Ophthalmic liquids, Lyophilised Ophthalmic powders, Terminally sterilized Ophthalmic liquidsNoneAmos Mulera Atumanya6/21/2022
201IRF/F/120/08/2019 183/GMP/2019 Cert No.Micropure Parenterals Private LimitedPlot 136 Neharoli village, Taluka , Wada district, Maharashtra IndiaIndia28-KD/240 expiry 31/12/20228/2/2017RT863455/14/20195/14/2022Non-beta lactam (Human), Cephalosporin (Human)Non-beta lactam (Human): Small volume liquids (Aseptically filled) – Vials and Ampoules Cephalosporin (Human): Powder for injection (Aseptically filled) – VialsNon-beta lactam (Human): Small volume liquids (Aseptically filled) – Vials and Ampoules Cephalosporin (Human): Powder for injection (Aseptically filled) – VialsNoneFarida Khaukha5/14/2022
202IRF/F/124/09/2019 Cert No. 012/GMP/2020VHB Medi Sciences LimitedPlot No 20-22 & 49-51 Industrial Estate, Sector 5, Sidcul Rudrapur Uttarakhand, IndiaIndiaLicense no. 17/P/I/52/2007/IB057 valid up to 03/12/20222/8/2018RT930075/10/20195/10/2022Non-beta lactam (Human), Oncology products, Hormone products, Beta lactam (Human)Non-beta lactam (Human): Aseptically filled small volume parenterals, Aseptically filled lyophilized small volume powders, Dry powder for injection, aseptically filled
Oncology products: Aseptically filled small volume parenterals, Aseptically filled lyophilized small volume powders.
Hormone products: Aseptically filled small volume parenterals, Aseptically filled lyophilized small volume powders. Beta lactam (Human): Small Volume Parenteral (SVP)-Dry Powder Cephalosporin line
Non-beta lactam (Human): Aseptically filled small volume parenterals, Aseptically filled lyophilized small volume powders, Dry powder for injection, aseptically filled
Oncology products: Aseptically filled small volume parenterals, Aseptically filled lyophilized small volume powders.
Hormone products: Aseptically filled small volume parenterals, Aseptically filled lyophilized small volume powders. Beta lactam (Human): Small Volume Parenteral (SVP)-Dry Powder Cephalosporin line
NoneFarida Khaukha5/10/2022
203IRF/F/125/09/2019 GMP Cert No. 006/GMP/2020Medley Pharmaceuticals LimitedPlot 18 & 19 Survey no. 378/7&8, 379/2&3 Zari Causeway Road, Kachigam Daman-396210, IndiaIndiaDD/220 and DD/221 valid until 31/12/20218/2/2017RT863205/21/20195/21/2022Non-beta lactamNon-beta lactam: Tablets
(Coated and uncoated), Hard gelatin capsules, Liquid for internal use (Syrups and Suspensions)
Non-beta lactam: Tablets
(Coated and uncoated), Hard gelatin capsules, Liquid for internal use (Syrups and Suspensions)
NoneFarida Khaukha5/21/2022
204IRF/F/126/09/2019 GMP Cert No. 004/GMP/2020Torque Pharmaceuticals Pvt LimitedUnit 1, Village- Issapur, Post: Dappar, Distt-Mohali, Punjab- 140506, IndiaIndiaForm 26;1531-OSP and 1524-B valid up to 31/12/202111/30/2017RT90326/ RT903275/24/20195/24/2022Non-beta lactamNon-beta lactam: Tablets, Oral liquids, External preparations (Creams, ointments, lotions & external liquids)Non-beta lactam: Tablets, Oral liquids, External preparations (Creams, ointments, lotions & external liquids)NoneMwesigwa Denis5/24/2022
205IRF/F/127/09/2019 GMP Cert No. 007/GMP/2020Brawn Laboratories Limited13, NIT, Industrial Area, Faridabad- 121001, Haryana, IndiaIndiaForm 25, No. 671-OSP(H) & Form 28, No. 379-B(H), Valid until 31.12.20216/12/2018RT970016/6/20196/6/2022Non-beta lactam, Beta lactam-Cephalosporin, Beta lactam-PenicillinNon-beta lactam: Tablets, Oral liquids, Hard Gelatin capsules, SVP-solutions (Ampoules, vials, pre-filled syringes), SVP-powders (Lyophilized), Eye/Ear/Nasal drops, Creams and Ointments, Dry powder for oral suspension. Beta lactam-Cephalosporin: Tablets, Dry powder for oral suspension, SVP-powders, Hard Gelatin capsules. Beta lactam-Penicillin: Dry powder for oral suspension, Hard Gelatin capsulesNon-beta lactam: Tablets, Oral liquids, Hard Gelatin capsules, SVP-solutions (Ampoules, vials, pre-filled syringes), SVP-powders (Lyophilized), Eye/Ear/Nasal drops, Creams and Ointments, Dry powder for oral suspension. Beta lactam-Cephalosporin: Tablets, Dry powder for oral suspension, SVP-powders, Hard Gelatin capsules. Beta lactam-Penicillin: Dry powder for oral suspension, Hard Gelatin capsulesNoneMwesigwa Denis6/6/2022
206IRF/F/128/09/2019 GMp Cert No. 016/GMP/2020Nanz Med Science Pharma Pvt. LimitedRampur Ghat, Paonta Sahib, District Sirmour-173025, Himachal Pradesh, IndiaIndiaForm 25, Number S-MNB/09/41 & Form 28 Number S-MB/09/42, Valid until 26/04/20246/18/2018RT97148/RT971495/28/20195/28/2022Non-beta lactamNon-beta lactam: Liquids for external use, Semi-solids (Ointments, creams, lotions), Dusting powdersNon-beta lactam: Liquids for external use, Semi-solids (Ointments, creams, lotions), Dusting powdersNoneMwesigwa Denis5/28/2022
207IRF/F/129/09/2019 GMP Cert No. 003/GMP/2020Medicamen Biotech LimitedSP-1192, A & B, Phase -1V, Industrial Area, Bhiwadi-301019, Distt. Alwar, Bhiwadi (Rajasthan)-IndiaIndiaForm 25, No. RAJ-1697 & Form 28, No. RAJ-1698, Valid until 31.12.20217/18/2018RT994715/31/20195/31/2022Non-Beta Lactam, Beta LactamNon-Beta Lactam: Tablets, Dry Powder in sachets (ORS), Hard Gelatin capsules, Oral Liquids, Dry powder for suspension.
Beta Lactam: Tablets, Hard Gelatin capsules, Dry powder for suspension.
Non-Beta Lactam: Tablets, Dry Powder in sachets (ORS), Hard Gelatin capsules, Oral Liquids, Dry powder for suspension.
Beta Lactam: Tablets, Hard Gelatin capsules, Dry powder for suspension.
NoneMwesigwa Denis5/31/2022
208IRF/F/130/07/2019 GMP cert No. 017/GMP/2020Unique Pharmaceutical LaboratoriesSurvery No. 101/2 and 102/1, Daman Industrial Estate, Airport Road, Village Kadaiya Daman 396210IndiaDD/L/467 and DD/L/466 validity 26/04/2020 DD/L/779 and DD/L/780 validity 29/05/20216/19/2017RT838873/8/20193/8/2022Non-Beta LactamNon-Beta Lactam: Tablets (coated and uncoated), Lozenges, Oral powders in sachets.
Non-Beta Lactam: Tablets (coated and uncoated), Lozenges, Oral powders in sachets.
NoneKenneth Kiiza3/8/2022
209IRF/F/131/07/2019 GMP Cert No. 078/GMP/2020Franco Indian Pharmaceuticals Pvt. Limited54B, Sir M.V. Road, Andheri (E) Mumbai 400-093-IndiaIndia25-9 issued by Food & Drugs Administration (Maharashtra State) Validity Period:01/01/2018 To 31/12/20222/15/2018RT848188/27/20198/27/2022Hormones (Steroids), Non-beta lactamHormones (Steroids): Semi-solids
(creams, ointments, gels).
Non-beta lactam: Semi-solids
(creams, ointments, gels).
Hormones (Steroids): Semi-solids
(creams, ointments, gels).
Non-beta lactam: Semi-solids
(creams, ointments, gels).
NoneKaleebu Frank8/27/2022
210IRF/F/132/09/2019 136/GMP/2019 GMP Cert dateBeacon Pharmaceuticals LimitedKathali, Bhaluka, Mymensingh, BangladeshBangladeshLicense No 258 and 477 (For manufacture of biological and non-biological products)8/3/2018RT100033, RT1000345/15/20195/15/2022Non-Beta LactamNon-Beta Lactam: Tablets, Tablets in capsule shell, Pellets and Powders packed in Hard Gelatin Capsules, Liquid in Hard Gelatin Capsules, Oral liquids (syrups and suspensions), Aseptically prepared small volume liquids, Aseptically prepared lyophilized powders, Terminally sterilized large volume liquids. Oncology Products: Tablets, Hard Gelatin capsules, Aseptically prepared small volume liquids, Aseptically prepared lyophilized products.
Non-Beta Lactam: Tablets, Tablets in capsule shell, Pellets and Powders packed in Hard Gelatin Capsules, Liquid in Hard Gelatin Capsules, Oral liquids (syrups and suspensions), Aseptically prepared small volume liquids, Aseptically prepared lyophilized powders, Terminally sterilized large volume liquids. Oncology Products: Tablets, Hard Gelatin capsules, Aseptically prepared small volume liquids, Aseptically prepared lyophilized products.
NoneKariuki Gachoki (EAC)5/15/2022
211IRF/F/133/09/2019 173/GMP/2019 Cert No.Alphalytik Pharmaservice GmbhGrunberger Str.44 10245 Berlin, GermanyGermanyDE_BE_01_GMP_2019_OE_0001 Valid from 28/11/20212/25/2019RT1073496/4/20196/4/2022Laboratory testingLaboratory testing: TabletsLaboratory testing: TabletsNoneJuliet Awori Okecho6/4/2022
212IRF/F/136/09/2019 GMP Cert No. 024/GMP/2020Liorad LaboratoriesAve.27A, No.26402e/ 264&268 San Agustin. La Lisa, Havana -CubaCuba018-16-M8/24/2017RT869576/11/20196/11/2022Aseptically filled, Terminally sterilizedAseptically filled: Small volume parenteral liquids, Lyophilized powders. Terminally sterilized: Small volume parenteral liquids.Aseptically filled: Small volume parenteral liquids, Lyophilized powders. Terminally sterilized: Small volume parenteral liquids.NoneJuliet Awori Okecho6/11/2022
213IRF/F/137/10/2019 GMP Cert No. 033/GMP/2020Rusan Pharma LimitedKhasra No. 122MI, Central Hope Town, Behind Pharma City, Selaqui, Dehradun-248197, Uttarakhand, IndiaIndiaForm 25-19/UA/2008 & Form 28-22/UA/SC/P-2008, Valid until 05/01/202010/1/2018RT1018935/21/20195/21/2022Non-beta lactamNon-beta lactam: Tablets, Liquids for internal use, Transdermal patches, SVP liquids and pre-filled syringes, SVP lyophizesNon-beta lactam: Tablets, Liquids for internal use, Transdermal patches, SVP liquids and pre-filled syringes, SVP lyophizesNoneDenis William Mwesigwa5/21/2022
214IRF/F/138/10/2019 178/GMP/2019 Cert No.Rusan Pharma Limited, Unit IPlot No. 59 - 65, Sector II, Kandla Special Economic zone, Gandhidham Kutch 370 230 Gujarat, IndiaIndiaG/25/1558 and G/28/112610/1/2018RT1018946/19/20196/19/2022Non-beta lactam (Human). Beta lactam -Penicillin & Non-beta lactam (Human), Beta lactam -Penicillin (Human).Non-beta lactam (Human): Terminally sterilized small volume liquids (vials and ampoules), Powders in sachets, Tablets, Creams /Ointments & Gels. Beta lactam -Penicillin & Non-beta lactam (Human): Hard gelatin capsules. Beta lactam -Penicillin (Human): Powders for oral suspension.Non-beta lactam (Human): Terminally sterilized small volume liquids (vials and ampoules), Powders in sachets, Tablets, Creams /Ointments & Gels. Beta lactam -Penicillin & Non-beta lactam (Human): Hard gelatin capsules. Beta lactam -Penicillin (Human): Powders for oral suspension.NoneNakimuli Eunice Lukakamwa6/19/2022
215IRF/F/139/10/2019 GMP Cert No. 039/GMP/2020Human Biologicals Institute (A division of Indian Immunologicals Limited)Rakshapuram, Gachibowli post, Hyderabad- 500032, Telangana, IndiaIndiaLicence no. 02/RR/AP/2005/V/R (in form 28-D) valid until 15.04.202110/24/2018RT1025837/4/20197/4/2022VaccinesVaccines: Tetanus vaccine (adsorbed), Diphtheria, Tetanus and Pertussis (adsorbed), Recombinant Hepatitis B vaccine, Combined Diphtheria, Tetanus, Pertussis (whole cell), Hepatitis B and Haemophilus influenza type-B conjugate vaccine (adsorbed)Vaccines: Tetanus vaccine (adsorbed), Diphtheria, Tetanus and Pertussis (adsorbed), Recombinant Hepatitis B vaccine, Combined Diphtheria, Tetanus, Pertussis (whole cell), Hepatitis B and Haemophilus influenza type-B conjugate vaccine (adsorbed)NoneAmos Mulera Atumanya7/4/2022
216IRF/F/140/10/2019 GMP Cert No. 022/GMP/2020Artepharm Company LimitedFengshun Economic and Technological Development Zone Industrial Park, Meizhou, Guangdon, ChinaChinaGD20180880, Valid up to 14 October 2023and issued by China Food and Drug Administration4/3/2018RT94629,RT946305/17/20195/17/2022Non-beta lactamNon-beta lactam: Tablets (coated and uncoated)Non-beta lactam: Tablets (coated and uncoated)NoneMichael Romeo Mutyaba5/17/2022
217IRF/F/143/10/2019 002/GMP/2020 Cert No.Modi-Mundipharma Private LimitedMeerut- Muzaffamagar Road, Modipuram - 250110, U.P. IndiaIndiaOn forms 25-29 of 1992 and 28-24/SC/199211/27/2018RT1037336/25/20196/25/2022Non-beta lactam (Human)Non-beta lactam (Human): TabletsNon-beta lactam (Human): TabletsNoneNakimuli Eunice Lukakamwa6/25/2022
218IRF/F/144/10/2019 GMp Cert No. 018/GMP/2020Sandoz Private Limited, KalweMIDC Plot No. 8-A/2, 8-B, T.T.C. Industrial Area, Kalwe Block, Village Digha, Navi Mumbai 400 708, Maharashtra, IndiaIndia25-KD/548 Validity Period:14/06/2019 To 13/06/2024 Issued by: Food & Drugs Administration (Maharashtra State)2/11/2019RT958808/30/20198/30/2022Non-beta lactamNon-beta lactam: Tablets, Hard gelatin capsulesNon-beta lactam: Tablets, Hard gelatin capsulesNoneKaleebu Frank8/30/2022
219087/GMP/2019 DRHelsin Birex Pharmaceuticals LimitedDamastown, Mulhuddart, Dublin 15 - IrelandIreland4/4/2018RT946656/5/20196/5/2022Secondary Packaging Chemical/Physical testingSecondary Packaging Chemical/Physical testingSecondary Packaging Chemical/Physical testingNoneAmos Mulera Atumanya6/5/2022
220088/GMP/2019 DRLek Pharmaceuticals d. d., Lendava Solids SiteTrimlini 2D, 9220 Lendava – SloveniaSlovenia5/7/2018RT958796/5/20196/5/2022Non-Beta LactamNon-Beta Lactam: Tablets
Hard gelatin capsules
Soft gelatin capsules
Non-Beta Lactam: Tablets
Hard gelatin capsules
Soft gelatin capsules
NoneAmos Mulera Atumanya6/5/2022
221089/GMP/2019 DRActavis LimitedBLB015-016, Bulebel Industrial Estate, Zejtun ZTN3000 Malta Germany5/10/2018RT959966/6/20196/6/2022Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneAmos Mulera Atumanya6/6/2022
222094/GMP/2019 DRSanofi Winthdrop Industrie56, route de Choisy au Bac – 60205 Compiegne, France France6/6/2016RT713256/14/20196/14/2022CephalosporinCephalosporin: Tablets,
Other solid dosage forms
Cephalosporin: Tablets,
Other solid dosage forms
NoneKaleebu Frank6/14/2022
223095/GMP/2019 DRSANOFI PASTEUR - Marcy l'etoileCampus Merieux 1541 avenue marcel merieux 69280, Marcy l'etoile - FranceFrance2/27/2019RT527876/6/20196/6/2022SVP Liquids (Non-Beta Lactam)SVP Liquids (Non-Beta Lactam): VaccinesSVP Liquids (Non-Beta Lactam): VaccinesNoneKaleebu Frank6/6/2022
224096/GMP/2019 DRWest-Ward Columbus Inc1809 Wilson Road, Columbus Ohio 43228 – USAUnited States Of America3/5/2019RT1075986/19/20196/19/2022Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneKaleebu Frank6/19/2022
225097/GMP/2019 DRSiegfried Hameln GmbHLanges Feld 13, 31789 Hameln - GermanyGermany4/16/2019RT1097456/20/20196/20/2022Non-Beta LactamNon-Beta Lactam: SVP Liquids in Ampoules & Vials,
LVP Liquids
Non-Beta Lactam: SVP Liquids in Ampoules & Vials,
LVP Liquids
NoneEmurwon Kosiya6/20/2022
226098/GMP/2019 DRGlaxoSmithKline BiologicalsRue de l'institut 89 - 1330 Rixensart - BelgiumBelgium3/14/2019RT1073476/20/20196/20/2022Non-Beta LactamNon-Beta Lactam: SVP Liquids in Vials, LVP Liquids, SVP Lyophilisates
Non-Beta Lactam: SVP Liquids in Vials, LVP Liquids, SVP Lyophilisates
NoneEmurwon Kosiya6/20/2022
227099/GMP/2019 DRKaiseraugst (Pharma)CH 4303 Kaiseraugst, Wurmisweg - SwitzerlandSwitzerland12/23/2013RT463446/25/20196/25/2022Non-Beta LactamNon-Beta Lactam: Secondary Packaging of SVP Liquids, Primary packaging of Tables
Non-Beta Lactam: Secondary Packaging of SVP Liquids, Primary packaging of Tables
NoneKaleebu Frank6/25/2022
228105/GMP/2019 DRSofarimex Industria Quimica e Farmaceutica, S. A.Av das Industrias-Alto do Colaride, 2735-213 Agualva Cacem - PortugalPortugal5/8/2018RT959447/10/20197/10/2022Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsule
Semi-solids
SVP Liquids in Ampoules
SVP Lyophilisates
Eye drops
Non-Beta Lactam: Tablets
Hard Gelatin Capsule
Semi-solids
SVP Liquids in Ampoules
SVP Lyophilisates
Eye drops
NoneEmurwon Kosiya7/10/2022
229110/GMP/2019 DRBoehringer Ingelheim Pharma GmbH and Company KGBinger Str. 173,55216 Ingelheim Am Rhein - GermanyGermany3/5/2019RT1075987/22/20197/22/2022Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsule
Metered Dose Inhalers
Non-Beta Lactam: Tablets
Hard Gelatin Capsule
Metered Dose Inhalers
NoneEmurwon Kosiya7/22/2022
230125/GMP/2019 DRAbbVie, Inc (North Chicago Facility)1401 Sheridan Road, North Chicago, IL 60064-4000United States Of America5/17/2019RT1108169/8/20199/8/2022Animal Extracted ProductsAnimal Extracted Products: Intratracheal SuspensionsAnimal Extracted Products: Intratracheal SuspensionsNoneEmurwon Kosiya9/8/2022
231126/GMP/2019 DRBoehringer Ingelheim Ellas AE5th km Paiania – Markopoulo, Koropi Attiki, 19400 - GreeceGreece6/14/2019RT1117879/8/20199/8/2022Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneEmurwon Kosiya9/8/2022
232132/GMP/2019 DRBesins Manufacturing Belgium (BMB)Groot Bijgaardenstraat, 128. 1620 Drogenbos - BelgiumBelgium1/15/2018RT916379/10/20199/10/2022Non ?-lactam (Hormones)Non ?-lactam (Hormones): Semi-solid gelsNon ?-lactam (Hormones): Semi-solid gelsNoneAmos Mulera Atumanya9/10/2022
233142/GMP/2019 DRV.M.D. n.v.Hoge Mauw 900 – 2370 ArendonkBelgium12/19/2018201812131017028523ISABEL10/4/201910/4/2022Non ?-lactam Beta LactamNon ?-lactam: Large Volume Parenteral Liquids, Small Volume Parenterals, Oral Liquids, Oral Dry Powders for Suspension,
Beta Lactam: Large Volume Parenteral Liquids, Oral Dry Powders for Suspension, Small Volume Parenterals.
Non ?-lactam: Large Volume Parenteral Liquids, Small Volume Parenterals, Oral Liquids, Oral Dry Powders for Suspension,
Beta Lactam: Large Volume Parenteral Liquids, Oral Dry Powders for Suspension, Small Volume Parenterals.
NoneEmurwon Kosiya10/4/2022
234144/GMP/2019 DRHerd Mundy Richardson LimitedOak House, Bredbury Park way, Ashton Road, Bredbury, Stockport, SK6 2SN – United KingdomUnited Kingdom5/17/2019RT11085510/7/201910/7/2022HormonesHormones: GelsHormones: GelsNoneEmurwon Kosiya10/7/2022
235145/GMP/2019 DRCentral Pharma (Contract Packing) LimitedCaxton Road, Bedford, MK41 OXZ – United KingdomUnited Kingdom5/17/2019RT11085610/7/201910/7/2022HormonesHormones: GelsHormones: GelsNoneEmurwon Kosiya10/7/2022
236IRF/F/147/10/2019 GMP Cert No. 043/GMP/2020Shanghai Desano Biopharmaceutical Company Limited1479 Zhangheng Road, Shanghai, ChinaChinaHu20160073 valid up to 31 Dec March 2020, issued by Shanghai Food and Drug Administration 6/6/2018RT968285/14/20195/14/2022Non-beta lactamTablets, Hard gelatin capsulesTablets, Hard gelatin capsulesNoneOkello Andrew5/14/2022
237IRF/F/148/10/2019 068/GMP/2020 GMP Cert No.S Kant Healthcare Limited1802 – 1805, G.I.D.C., Phase III, Vapi -396195 Gujarat, India.IndiaG/1344 and G/986 Valid from 01/01/2017 to 31/12/202112/15/2017RT90738 / RT1191039/7/20199/7/2022Steroidal hormones, Non-beta lactamSemi-solids (creams, ointments, gels), Semi-solids (creams, ointments, gels), Liquids for internal use, Tablets, Hard gelatin capsules, Powders for oral suspensionsSemi-solids (creams, ointments, gels), Semi-solids (creams, ointments, gels), Liquids for internal use, Tablets, Hard gelatin capsules, Powders for oral suspensionsNoneKaleebu Frank9/7/2022
238IRF/F/149/10/2019 GMP Cert No. 019/GMP/2020Mistair Health and Hygiene Pvt LimitedPlot No.3, M.I.D.C, Shilori, Kolhapur 416122, Maharashtra, IndiaIndia25-PD 95 valid up to 22//08/2023 and 28-PD 83 valid up to 16/04/202211/2/2016RT75591/RT755907/3/20197/3/2022Non-beta Lactam (Human and Veterinary)Oral liquids, Powders for oral suspension, Liquid for external use, Sterile granules for injection in Sachets Oral liquids, Powders for oral suspension, Liquid for external use, Sterile granules for injection in Sachets NoneNakimuli Eunice Lukakamwa7/3/2022
239IRF/F/150/10/2019 057/GMP/2020 GMP Cert No.Shandong Luxi Animal Medicine Share Co. LimitedNo 5 Waihuanxi road, West of Qihe County, Shandong Province, P.R. ChinaChina(2015) V.M.M.C.No.15051 valid till 22/09/2020 issued by Shangdong Provincial Animal Husbandry & Veterinary Bureau5/29/2018RT966025/11/20195/11/2022Non-beta lactamLiquids for external use (acaricide), Liquids for internal use, Powder – PremixLiquids for external use (acaricide), Liquids for internal use, Powder – PremixNoneOkello Andrew5/11/2022
240IRF/F/151/10/2019 GMP Cert No. 014/GMP/2020Elanco (Shanghai) Animal Health Limited1 Changzhong Road, Wusi Farm, Fengxian District, Shanghai 201423, ChinaChinaS.Y.S.C.Z.Z No 09001 Valid up to 3rd February, 2022, No. 09002 Issued on 2017 February 4th - Valid up to 3rd February, 202211/13/2018RT1029848/6/20198/6/2022Non-beta lactamOral Veterinary Powder, Oral Veterinary PremixesOral Veterinary Powder, Oral Veterinary PremixesNoneWilberforce Kwiringira8/6/2022
241IRF/F/154/11/2019 GMP Cert No. 041/GMP/2020Aurochem Laboratories (I) Pvt LimitedPlot 08 Palghar 40104 Maharashtra, IndiaIndia(25) KD-326 and (28) KD-25812/4/2018RT1039629/24/20199/24/2022Non-beta lactamNon-beta lactam: Oral liquid line, External creams and ointmentsNon-beta lactam: Oral liquid line, External creams and ointmentsNoneNahamya David9/24/2022
242IRF/F/155/11/2019 GMP Cert No. 335/GMP/2020Aurochem Pharmaceuticals (I) Pvt. LimitedPlot 58 Palghar 40104 Maharashtra, IndiaIndia12/4/2018RT1039639/24/20199/24/2022Non-beta lactamHard Gelatin Capsule line, TabletsHard Gelatin Capsule line, TabletsNoneNahamya David9/24/2022
243IRF/F/156/11/2019 GMP Cert No. 042/GMP/2020Aspiro Pharma LimitedSy No. 321, Biotech Park, Phase-III, Karkapatla Village, Markook Mandal, Siddipet Dist. 502281, Telangana State, IndiaIndia36/MD/AP/2013/F/G4/13/2018RT946939/17/20199/17/2022Non-beta lactamNon-beta lactam: Lyophilisates, Aseptically prepared small volume liquids, Terminally sterilized small volume liquidsNon-beta lactam: Lyophilisates, Aseptically prepared small volume liquids, Terminally sterilized small volume liquidsNoneNahamya David9/17/2022
244IRF/F/158/11/2019 054/GMP/2020 GMP Cert No.Macleods Pharmaceuticals Limited Block N1Village Theda, PO : lodhi Majra, Tehsil Baddi, Dist. Solan, Himachal Pradesh 174101, IndiaIndia3/29/2019RT1083889/20/20199/20/2022Non-beta lactamTablets, Hard gelatin capsules, Soft gelatin capsulesTablets, Hard gelatin capsules, Soft gelatin capsulesNoneNahamya David9/20/2022
245IRF/F/159/11/2019 099/GMP/2020 GMP Cert No.Aculife Healthcare Pvt LimitedVillage Sachana, Taluka, Viramgam, Dist. Ahmedabad 382150, Gujarat - India IndiaForm 25: License number G/25/1783 valid until 13/08/2020, Form 28: License number G/28/1221 valid until 13/08/2020, Form 28-B: License number G/28-B/8 valid until 19/08/2020, Form 28-D: License number G/28D/LVP/8 valid until 06/08/20202/1/2017RT792179/17/20199/17/2022Non-beta lactam, BiologicalsLVP Liquids (Units 1 & 2) – Aseptically filled and Terminally sterilized, SVP Liquids (Unit 2 & 5) - Aseptically filled and Terminally sterilized, SVP Liquids (Unit 5) - Aseptically filledLVP Liquids (Units 1 & 2) – Aseptically filled and Terminally sterilized, SVP Liquids (Unit 2 & 5) - Aseptically filled and Terminally sterilized, SVP Liquids (Unit 5) - Aseptically filledNoneEtuko Daniel9/17/2022
246IRF/F/161/11/2019 GMP Cert No. 325/GMP/2020Micro Labs LimitedNo. 92, SIPCOT Industrial Complex, Hosur 635126 Tamilnadu - IndiaIndiaForm 25: License No. 300 valid up to 31.12.2021, Form 28: License No. 148 valid up to 31.12.20219/25/2018RT1017659/13/20199/13/2022Non Beta lactamTablets (Coated & Uncoated), Capsules (Hard gelatin), Powder for Oral suspension / solution, Semi solids (Creams, Ointments & Gels)Tablets (Coated & Uncoated), Capsules (Hard gelatin), Powder for Oral suspension / solution, Semi solids (Creams, Ointments & Gels)NoneEtuko Daniel9/13/2022
247IRF/F/162/11/2019 066/GMP/2020 GMP Cert No.Asiatic Agricultural Industries Pte. Limited150 Gul Circle Singapore 629607SingaporeCert No: 034/GMP/2017 valid till April 2023 for Production of Ectoparasticides) by the Ministry of Manpower- Singapore5/10/2019RT11058210/15/201910/15/2022EctoparasiticideEctoparasiticide: SolutionEctoparasiticide: SolutionNoneMwesigwa Denis10/15/2022
248IRF/F/163/11/2019 048/GMP/2020 GMP Cert No.Hebei Bimeda Pharmaceutical Technology Company LimitedNo.60, Ganjiang Road Shijiazhuang Economic & Technological Development ZoneChinaBusiness Licence 911301000837836447 1002018/13/2019RT11521510/18/201910/18/2022Non-beta LactamNon-beta Lactam: Small Volume Parenterals - Liquid Injection, Large Volume Parenterals - Liquid InjectionNon-beta Lactam: Small Volume Parenterals - Liquid Injection, Large Volume Parenterals - Liquid InjectionNoneMwesigwa Denis10/18/2022
249IRF/F/164/11/2019 073/GMP/2020 GMP Cert No.Hebei Kexing Pharmaceutical Company LimitedNo.114 Changsheng street, Liquan Development Zone, Shijiazhuang City Hebei Province, P.R. ChinaChinaVeterinary Manufacturing License No:-03011 valid till 08/02/2020 issued by Hebei Province department of Veterinary services and Animal Husbandry7/26/2019RT107128 / RT11441710/23/201910/23/2022Non-beta lactamNon-beta lactam: Tablets/Boluses, Oral liquids, Premixes, SVP- solutions (terminally Sterilized), LVP- solutions- (Gamma radiation sterilized & terminally Sterilized), Oral Powder, GranulesNon-beta lactam: Tablets/Boluses, Oral liquids, Premixes, SVP- solutions (terminally Sterilized), LVP- solutions- (Gamma radiation sterilized & terminally Sterilized), Oral Powder, GranulesNoneMwesigwa Denis10/23/2022
250IRF/F/165/12/2019 GMP Cert No.: 018/GMP/2021Abacus Parenteral Drugs LimitedBlock 191, Plot No. 114 Kinga Mukono, UgandaUgandaNDA/PRE/PMC/2378 (valid until 31/12/2017)11/13/201911/13/2022Non-beta lactamNon-beta lactam: Small Volume Liquids (Aseptically filled and terminally sterilized), Large Volume Liquids (Terminally sterilized)Non-beta lactam: Small Volume Liquids (Aseptically filled and terminally sterilized), Large Volume Liquids (Terminally sterilized)NoneKaleebu Frank11/13/2022
251IRF/F/166/12/2019 174/GMP/2019 GMP Cert No.Indoco Remedies Limited - Unit IIL-32,33,34, Verna Industrial Area, Verna GOA 403722 - IndiaIndiaNo 557 on Form 26 valid up to 14/03/20223/28/2018RT94556, RT107768/30/20198/30/2022Non-beta lactamNon-beta lactam: Small Volume Liquids (Aseptically filled / terminally sterilized), Sterile Ophthalmic Solution (Aseptically filled /terminally sterilized)Non-beta lactam: Small Volume Liquids (Aseptically filled / terminally sterilized), Sterile Ophthalmic Solution (Aseptically filled /terminally sterilized)NoneZaidi Mwondha8/30/2022
252IRF/F/168/12/2019 078/GMP/2020 GMP Cert No.Medreich Limited India - Unit 112th Mile, Old Madras Road, Virgonagar, 560049 BangaloreIndiaKR/DRUGS/SP-46/763/14/2019RT1073479/7/20199/7/2022Beta Lactam (Penicillin)Beta Lactam (Penicillin): Tablets (Coated and Uncoated), Hard gelatin capsules, Oral Powders for suspensionBeta Lactam (Penicillin): Tablets (Coated and Uncoated), Hard gelatin capsules, Oral Powders for suspensionNoneZaidi Mwondha9/7/2022
253IRF/F/170/12/2019 049/GMP/2020 GMP Cert No.Psychotropics India LimitedPlot No. 12 & 12A, Industrial Park-2, Phase-1, Salempur, Mehdood-2, Haridwar-249403 (Uttarakhand) IndiaIndiaForm 25; 28/UA/2010 Form 28; 30/UA/SC/P-2010 Validity 19/03/20201/3/2019RT105509 RT1055129/17/20199/17/2022Non-beta lactam, CephalosporinNon-beta lactam: Tablets (coated and uncoated), Hard Gelatin Capsules, SVP Liquids – aseptically filled and terminally sterilized (packed in ampoules and vials), SVP Powders – aseptically prepared (packed in vials). Cephalosporin: SVP Powders – aseptically prepared (packed in vials), Tablets (coated and uncoated), Dry Powders for oral suspensionNon-beta lactam: Tablets (coated and uncoated), Hard Gelatin Capsules, SVP Liquids – aseptically filled and terminally sterilized (packed in ampoules and vials), SVP Powders – aseptically prepared (packed in vials). Cephalosporin: SVP Powders – aseptically prepared (packed in vials), Tablets (coated and uncoated), Dry Powders for oral suspensionNoneLukwago Mohammad9/17/2022
254IRF/F/171/12/2019 GMP Cert No. 269/GMP/2020Human Biologicals Institute (A division of Indian Immunologicals Limited)Kozhipannai, PO, Udhagamandalam - 643007, (Ooty), Tamil Nadu IndiaIndia15 on Form 26H, issued on 16.08.1998 and renewed from 01.01.2017 to 31.12.202110/24/2018RT102585, RT102584,9/20/20199/20/2022Biological productsBiological products: Lyophilized Human Rabies Vaccine (packed in Small Volume Parenteral vials) – aseptically preparedBiological products: Lyophilized Human Rabies Vaccine (packed in Small Volume Parenteral vials) – aseptically preparedNoneLukwago Mohammad9/20/2022
255IRF/F/172/12/2019 GMP Cert No. 023/GMP/2020M/s Acme Generics LLPPlot No. 115, HPSIDC, Industrial Area, Davni, P.O Gurumajra, Tehsil Nalagarh, Distt. Solan (H.P)- 174101, IndiaIndiaMNB/15/880 & MB/15/881 Validity 05.06.20202/1/2019RT1065879/10/20199/10/2022Non-beta lactam (General), Non-beta lactam(Hormones)Non-beta lactam (General): Tablets (coated and uncoated), Hard Gelatin Capsules. Non-beta lactam(Hormones): Tablets (coated and uncoated)Non-beta lactam (General): Tablets (coated and uncoated), Hard Gelatin Capsules. Non-beta lactam(Hormones): Tablets (coated and uncoated)NoneLukwago Mohammad9/10/2022
256IRF/F/173/12/2019 GMP Cert No. 040/GMP/2020Samrudh Pharmaceuticals Pvt LimitedJ-174 and J-168, M.I.D.C., Tarapur, Boisar, Thane, 401506, Maharashtra, IndiaIndiaKD 115 form 28 (Valid up to 31/12/2019).9/3/2019RT1161749/30/20199/30/2022Non ?-lactam, CephalosporinNon ?-lactam: Aseptically filled small volume liquids, Terminally sterilized small volume liquids, Powder for Injection. Cephalosporin: Powder for InjectionNon ?-lactam: Aseptically filled small volume liquids, Terminally sterilized small volume liquids, Powder for Injection. Cephalosporin: Powder for InjectionNoneNahamya David9/30/2022
257IRF/F/174/12/2019 GMP Cert No. 061/GMP/2020AMN Life Science Pvt Limited67/P-1 Malav, Area-Bhilad, Valsad-39105, Gujarat, IndiaIndiaG/28/1660 (valid up to 27/03/2023)9/10/2019RT1164479/27/20199/27/2022?-lactam?-lactam: Tablets, Hard Gelatin Capsules, Powder for oral suspension?-lactam: Tablets, Hard Gelatin Capsules, Powder for oral suspensionNoneNahamya David9/27/2022
258IRF/F/060/04/2019 156/GMP/2019 Cert No.Shaigan Pharmaceuticals (Pvt.) Limited14 Km, Adyala road post office Dahgal, Rawalpindi, PakistanPakistanForm 2 no. 000333 Valid until 202110/13/2017RT37458/RT8855211/27/201811/27/2021Non-beta lactam, Cephalosporin, HormonesNon-beta lactam: Tablet (Coated and Uncoated), Hard gelatin capsules, Dry powder for oral suspension, Oral liquid preparations, Small Volume parenteral – Lyophilized powder, Small Volume parenteral – Terminally sterilized, Small Volume parenteral – Ophthalmic solution aseptically prepared
Cephalosporin: Dry powder for oral suspension, Hard gelatin capsules, Dry powder for injection- small volume vials
, Hormones: Tablets, Small volume parenterals – Aseptically prepared, Small Volume parenterals – Lyophilized powder, Creams and lotions
Non-beta lactam: Tablet (Coated and Uncoated), Hard gelatin capsules, Dry powder for oral suspension, Oral liquid preparations, Small Volume parenteral – Lyophilized powder, Small Volume parenteral – Terminally sterilized, Small Volume parenteral – Ophthalmic solution aseptically prepared
Cephalosporin: Dry powder for oral suspension, Hard gelatin capsules, Dry powder for injection- small volume vials
, Hormones: Tablets, Small volume parenterals – Aseptically prepared, Small Volume parenterals – Lyophilized powder, Creams and lotions
NoneMwesigwa Denis11/27/2021
259158/GMP/2019 DRRubiepharm Arzneimettel GmbHBruder-Grimm-Str. 62, 36396 Steinau a. d. StraBe-GermanyGermany7/29/2019RT114624 / JV18/64911/12/201911/12/2022Non-Beta LactamNon-Beta Lactam: SuppositoriesNon-Beta Lactam: SuppositoriesNoneKaleebu Frank11/12/2022
260159/GMP/2019 DRSalutas Pharma GmbHOtto-von-Guericke Alle 1, D-39179 Barleben – GermanyGermany8/26/2019RT6305011/12/201911/12/2022Non-Beta LactamNon-Beta Lactam: Hard Gelatin Capsules
Tablets
Non-Beta Lactam: Hard Gelatin Capsules
Tablets
NoneKaleebu Frank11/12/2022
261160/GMP/2019 DRThe Mentholatum Company Limited1 Redwood Avenue, Peel Park Campus, East Kilbride - ScotlandScotland6/25/2019RT11221611/12/201911/12/2022Non-Beta LactamNon-Beta Lactam: Semi solids (Creams, Ointments, Gels)Non-Beta Lactam: Semi solids (Creams, Ointments, Gels)NoneKaleebu Frank11/12/2022
262161/GMP/2019 DRJanssen Ortho LLCState Road 933 Km 0.1, Mamey Ward, Gurabo, Puerto Rico 00778 – United States of AmericaUnited States Of America7/30/2019RT11470111/12/201911/12/2022Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneKaleebu Frank11/12/2022
263162/GMP/2019 DRAcino Pharma AGDornacherstrasse 114; 4147 Aesch - SwitzerlandSwitzerland5/20/2019RT11086111/12/201911/12/2022Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
NoneKaleebu Frank11/12/2022
264163/GMP/2019 DRS. M. Farmaceutici S.r.l.Zona Industriale – 85050 Tito (PZ) - ItalyItaly4/29/2019RT11024111/13/201911/13/2022Non-Beta LactamNon-Beta Lactam: SVP Liquids in vials
LVP Liquids
Non-Beta Lactam: SVP Liquids in vials
LVP Liquids
NoneKaleebu Frank11/13/2022
265164/GMP/2019 DRSanofi Winthrop Industrie180 rue Jean Jaures, 94700 Maisons – Alfort, FranceFrance8/30/2019FU19/140 - RT11240811/13/201911/13/2022BiologicalsBiologicals: Prefilled SyringesBiologicals: Prefilled SyringesNoneKaleebu Frank11/13/2022
266167/GMP/2019 DRColep Laupheim GmbH and Company KGFockestrasse 12, 88471 Laupheim - GermanyGermany2/9/2016RT6867311/11/201911/11/2022Non-Beta LactamNon-Beta Lactam: Pressurised preparations (Inhalers)Non-Beta Lactam: Pressurised preparations (Inhalers)NoneKaleebu Frank11/11/2022
267001/GMP/2020 DRSandoz GmbHBiochemiestrasse 10, A-6250 Kundl - AustriaAustria2/11/2019RT958801/2/20201/2/2023Cephalosporin, PenicillinCephalosporin: Tablets
Hard Gelatin Capsules
SVP Powders for injection (Aseptically prepared), Penicillin: Tablets
SVP Powders for injection (Aseptically prepared)
Powders for oral suspension
Cephalosporin: Tablets
Hard Gelatin Capsules
SVP Powders for injection (Aseptically prepared), Penicillin: Tablets
SVP Powders for injection (Aseptically prepared)
Powders for oral suspension
NoneKitimbo Brenda Clare1/2/2023
268IRF/F/176/12/2019 185/GMP/2019 GMP Cert No.Shantha Biotechnics Private Limited (A Sanofi Company)S. No. 274, Athvelli Village, Medchal Mandal – 501401, Medchal – Malkajgiri District, Telangana - IndiaIndiaLicense No. 01/RR/AP/97/V/R issued 16.06.1997, renewed on 13.01.2015 and valid up to 05.08.2019. Issued by the Department of Drugs Control Administration, Hyderabad; Government of Telangana.4/18/2018RT953659/5/20199/5/2022VaccineVaccine: Small Volume Parenteral Solution, in glass vialsVaccine: Small Volume Parenteral Solution, in glass vialsNoneAndrew Okello Okonye9/5/2022
269IRF/F/177/12/2019 044/GMP/2021 GMP Cert No.Ciron Drugs and Pharmaceuticals Private LimitedPlot No. 35-37, 43-45, CFC-B, Dewan Udhyog Nagar, Aliyali, Palghar – 401404, Maharashtra, India.IndiaKD656 on Form 25 and KD456 on Form 28 Issued on 22.08.2007, Renewed on 22.08.2017 and valid until 21.08.2022.4/25/2018RT955459/10/20199/10/2022Non-beta lactam (Human)Non-beta lactam (Human): Tablets (Coated, uncoated and dispersible)
Hard gelatin capsules
Dry powder for oral suspension
Liquids for internal use – Syrups
Creams and ointments for topical application
Non-beta lactam (Human): Tablets (Coated, uncoated and dispersible)
Hard gelatin capsules
Dry powder for oral suspension
Liquids for internal use – Syrups
Creams and ointments for topical application
NoneAndrew Okello Okonye9/10/2022
270IRF/F/002/01/2020 008/GMP/2020 GMP Cert No.Sovereign Pharma Private LimitedSurvey No. 46/1-4, Kadaiya village, Nani Daman – 396210, IndiaIndiaDD/449 granted by the Drugs Licensing Authority, UT of Daman and Diu, Daman on 26/11/2004 and renewed from 26-11-2014 to 25/11/20192/20/2019RT1072089/20/20199/20/2022Non ?-lactamNon ?-lactam: Aseptically filled small volume liquids, Terminally sterilized SVP liquids, Lyophilized SVP vialsNon ?-lactam: Aseptically filled small volume liquids, Terminally sterilized SVP liquids, Lyophilized SVP vialsNoneNambasa Victoria9/20/2022
271IRF/F/005/01/2020 GMP Cert No. 036/GMP/2021Cris Pharmaceuticals India LimitedE-11,UPSIDC Industrial area, Selaqui, Deahrdun-2480011 ,UttarakhandIndiaLicense no. 23/UA/2006 on form 25 and 23/UA/SC/P-2006 on form 28-E11 issued by the Controlling and Licensing Authority(Mfg) Garhwal Mandal of Uttarakhand, Valid from 11/04/2016 to 10/04/20212/13/2019RT106987 RT1069889/10/20199/10/2022Non ?-lactamNon ?-lactam: Tablets (coated and un coated), Oral Liquid dosage formNon ?-lactam: Tablets (coated and un coated), Oral Liquid dosage formNoneNambasa Victoria9/10/2022
272IRF/F/006/01/2020 GMP Cert No. 038/GMP/2020Naari Pharma Private LimitedPlot 14-16 & 55-57 and 55-5, sector -5, IIE, Pantnagar, Rudrapur-263153, Distt. U.S Nagar, Uttarakhad - IndiaIndia11/UA/2009 on form 25 and 12/UA/SC/P-2008 on form 28 issued on 21/11/2016 by the Drug Controlling and Licensing Authority (Mfg.) Uttarakhand) and valid up to 20-11/2021.9/21/2018RT1016739/17/20199/17/2022Non ?-lactam, HormonesNon ?-lactam: Tablets
(coated and uncoated)
, Hormones: Tablets
(coated and uncoated)
Non ?-lactam: Tablets
(coated and uncoated)
, Hormones: Tablets
(coated and uncoated)
NoneNambasa Victoria9/17/2022
273IRF/L/009/01/2020 067/GMP/2020 GMP Cert No.Lifeway Pharmaceutical Industries LimitedBlock 198, Plot 478 Nangwa Mukono_UgandaUgandaNDA/PRE/PMC/1535 valid up to 31st December 2019.11/3/201911/3/2022Non-Beta LactamNon-Beta Lactam: Tablets (Coated and Uncoated), Capsule (Hard gelatin)Non-Beta Lactam: Tablets (Coated and Uncoated), Capsule (Hard gelatin)NoneMwesigwa Denis11/3/2022
274IRF/F/010/01/2020 097/GMP/2020 GMP Cert No.Apex Laboratories Pvt. Limited - Plant 1B-23, SIDCO Pharmaceutical Complex Alathur, Kancheepuram District 603,IndiaIndia564/88 on Form 25 and 320/88 on Form 287/17/2019RT1140909/10/20199/10/2022Non-beta lactam (Human)Non-beta lactam (Human): Tablets (Coated and Uncoated)
Semi solids (Creams and Ointments)
Hard gelatin capsules
Non-beta lactam (Human): Tablets (Coated and Uncoated)
Semi solids (Creams and Ointments)
Hard gelatin capsules
NoneZaidi Mwondha9/10/2022
275IRF/L/012/01/2020 GMP Cert No. 249/GMP/2020Torrent Pharmaceuticals LimitedVillage: Bhud & Makhnu Majra, Tehsil: Baddi – 173205, Dist: Solan, Himachal Pradesh, IndiaIndiaMNB/05/183 & MB/05/184 granted on 22/09/2005 issued by Human & Family Welfare department (Himachal Pradesh) Valid from 22/09/2015 to 21/09/20204/17/2019RT1098209/10/20199/10/2022Non beta-lactamNon beta-lactam: Tablets, Capsules (hard gelatine)Non beta-lactam: Tablets, Capsules (hard gelatine)NoneSsali Peter9/10/2022
276IRF/L/013/01/2020 056/GMP/2020 GMP Cert datePanacea Biotec Pharma LimitedMalpuri Baddi, District Solan, Himachal Pradesh-173205 - IndiaIndiaMNB/05/202 & MB/05/203, validity 10/10/2020.5/31/2018RT966829/13/20199/13/2022Non-beta lactam (Human), Oncology (Human)Non-beta lactam (Human): Tablets
Hard Gelatin Capsules
Oral liquid
Ointments/Cream/Gel
Oral powder (fiber), Oncology (Human): SVP Liquids in vials
SVP Lyophilized powder in vials
Non-beta lactam (Human): Tablets
Hard Gelatin Capsules
Oral liquid
Ointments/Cream/Gel
Oral powder (fiber), Oncology (Human): SVP Liquids in vials
SVP Lyophilized powder in vials
NoneKenneth Kiiza9/13/2022
277IRF/L/014/01/2020 096/GMP/2020 GMP Cert No.Nobel Ilac Sanayi ve Ticaret. A.SEski Akcakoca Caddesi No: 299 Sancaklar Mahallesi 81100 Duzce, TurkeyTurkeyTR/GMP/2018/205 Valid till 12/04/20214/27/2018RT9567411/8/201911/8/2022Beta lactam (cephalosporin)Beta lactam (cephalosporin): TabletsBeta lactam (cephalosporin): TabletsNoneJuliet Awori Okecho11/8/2022
278IRF/L/015/01/2020 047/GMP/2020 GMP Cert No.Bilim Ilac San.ve Tic. A.S.Gebze Tesisi, Gebze Organize Sanayi Bolgesi 1900 Sokak, No:1904 Gebze-Kocaeli TurkeyTurkeyTR/UY/2019/27-0 Valid 7/11/2022.4/27/2018RT9567311/5/201911/5/2022Non beta-lactamNon beta-lactam: Tablets, Semisolid preparations (creams, ointments, gels), Liquid for internal use Non beta-lactam: Tablets, Semisolid preparations (creams, ointments, gels), Liquid for internal use NoneJuliet Awori Okecho11/5/2022
279IRF/L/016/01/2020 076/GMP/2020 GMP Cert No.Idol lLac Dolum A.S.Davutpasa caddesi. Cebe Ali Bey Sok. No. 20 34010/ Davutpasa - Topkapi / Istanbul, TurkeyTurkeyTR/GMP/2019/33 to 22/February/20224/2/2019RT108483 / RT7078011/12/201911/12/2022Non beta-lactamNon beta-lactam: Small volume liquids (aseptically filled), Small volume liquids (Terminally sterilised)Non beta-lactam: Small volume liquids (aseptically filled), Small volume liquids (Terminally sterilised)NoneJuliet Awori Okecho11/12/2022
280IRF/L/017/01/2020 082/GMP/2020 GM Cert No.Baoding Sunlight Herb Medicament CompanyNo. 3881, Great Wall South Street, Qingyuan district, Baoding City, Hebei Province, ChinaChina03131 valid up to 9th May 2024, Issued by Hebei Animal Husbandry and Veterinary Medicine Bureau6/24/2019RT112163 / RT11216411/2/201911/2/2022Non beta-lactamNon beta-lactam: Tablets & Granules
Oral liquids and Suspensions
LVP- solutions- (Gamma radiation sterilized & terminally Sterilized)
Intramammary/Intrauterine infusions (Gamma radiation / Ethylene Oxide sterilized), Beta lactam (Penicillin & Cephalosporins): Oral powders & Premixes
SVP Powders (aseptically filled)
LVP Solution (aseptically filled)
Non beta-lactam: Tablets & Granules
Oral liquids and Suspensions
LVP- solutions- (Gamma radiation sterilized & terminally Sterilized)
Intramammary/Intrauterine infusions (Gamma radiation / Ethylene Oxide sterilized), Beta lactam (Penicillin & Cephalosporins): Oral powders & Premixes
SVP Powders (aseptically filled)
LVP Solution (aseptically filled)
NoneMwesigwa Denis11/2/2022
281IRF/F/018/01/2020 GMP Cert No. 285/GMP/2020ILKO ILAC Sanayi Ve Ticaret A.S.3. O.S.B. Buyuk Kayacik Mah. Kuddusi Cad. 23. Sokak No. 1 42050 Selcuklu, TurkeyTurkeyTR/GMP/2018/171; Validity - 11/05/20214/2/2019RT10848211/15/201911/15/2022Non beta-lactamNon beta-lactam: Tablets, Hard gelatin capsules Non beta-lactam: Tablets, Hard gelatin capsules NoneJuliet Awori Okecho11/15/2022
282IRF/F/022/01/2020 GMP Cert No. 009/GMP/2021Apex laboratories Private limited (Plant III)510 Kunnam Village and Post, Thenneri (Via) Sriperumbudur Taluk, Kancheepuram Dist , Tamil Nadu, IndiaIndiaForm 25 - TN0000351 and Form 28- TN0000352, Validity 21/04/2016 to 20/04/20217/17/2019RT114091 / RT1140929/17/20199/17/2022Non-beta lactamNon-beta lactam: Liquids for internal useNon-beta lactam: Liquids for internal useNoneKeneth Kiiza9/17/2022
283IRF/F/025/02/2020 GMP Cert No. 233/GMP/2020Verve Human Care LaboratoriesPlot No. 15A Pharmacity, Selaqui, Dehradun, Uttarakhand, 248011, India.India25) 33/UA/2010 & (28) 34/UA/SC/P-2010 granted on 25/03/2010 renewed from 25/03/2015 to 24/03/2020 & (26-F) I/UA/X/2012 renewed from 08/08/2017 to 07/08/2022 issued by Drug controlling & licensing Authority (Uttarakhand).1/8/2019RT105697 RT1056989/13/20199/13/2022Non beta-lactamNon beta-lactam: Tablet, Small volume parenteral terminally sterilized in glass ampoules, Small volume parenteral aseptically filled in glass ampoulesNon beta-lactam: Tablet, Small volume parenteral terminally sterilized in glass ampoules, Small volume parenteral aseptically filled in glass ampoulesNoneSsali Peter9/13/2022
284IRF/F/029/02/2020 081/GMP/2020 GMP Cert No.Zhuhai United Laboratories (Zhongshan) Company LimitedPlot No. 12, Jialian Road, Tanzhou, Zhongshan, Guangdong Province, People’s Republic of ChinaChinaCertificate No: Yue20160306 Category Code: HabZbS. Certificate Authorised by: Food and Drug Administration of Guangdong province; Issued on 01/01/2016, Expiry date 31/12/20203/25/2019RT10825110/12/201910/12/2022Cephalosporin, Non-beta lactam, PenicillinCephalosporin: Tablets (Coated and Uncoated)
SVP - Powder for Injection, Aseptically produced in Glass Vials
, Non-beta lactam: Creams & Ointments, Penicillin: SVP – Powder for Injection, Aseptically filled in Glass Vials
SVP – Lyophilized Powders for Injection, Aseptically filled in Glass Vials
Cephalosporin: Tablets (Coated and Uncoated)
SVP - Powder for Injection, Aseptically produced in Glass Vials
, Non-beta lactam: Creams & Ointments, Penicillin: SVP – Powder for Injection, Aseptically filled in Glass Vials
SVP – Lyophilized Powders for Injection, Aseptically filled in Glass Vials
NoneNasser Lubowa10/12/2022
285IRF/F/031/02/2020 074/GMP/2020 GMP Cert No.Healton Animal Health Biotech Company LimitedNo. 898, Anji Street, Shizhong District, Neijiang City, Sichuan Province, People’s Republic of ChinaChinaVet production License; 22138 issued by Sichuan provincial Agricultural Department, Peoples Republic of China valid from 18/05/2018 to 17/05/20236/24/2019RT109793 RT10979210/9/201910/9/2022Non ?-lactam, Hormones, ?-lactamNon ?-lactam: Liquids for external use (Detergents), Powders/Premixes, Ectoparasiticides/ Acaricides, Small Volume Parenteral Solutions, Aseptically filled or terminally sterilized in Ampoules or Vials, Large volume parenteral solutions –Terminally Sterilised, Large Volume parenteral Solution- Infusions, BFS filled, Hormones: Small Volume Parenteral Solutions, Aseptically filled in Ampoules or Vials, ?-lactam: Small Volume Parenteral Solutions, Aseptically filled in VialsNon ?-lactam: Liquids for external use (Detergents), Powders/Premixes, Ectoparasiticides/ Acaricides, Small Volume Parenteral Solutions, Aseptically filled or terminally sterilized in Ampoules or Vials, Large volume parenteral solutions –Terminally Sterilised, Large Volume parenteral Solution- Infusions, BFS filled, Hormones: Small Volume Parenteral Solutions, Aseptically filled in Ampoules or Vials, ?-lactam: Small Volume Parenteral Solutions, Aseptically filled in VialsNoneNasser Lubowa10/9/2022
286IRF/F/032/02/2020 052/GMP/2020 GMP Cert No.Handok Inc.78, Daepungsandan-ro, Daeso-Myeon, Eumseong-gun, Chungcheongbuk-do ,27670, South Korea South KoreaLicense No. : 1374, License date: March 19, 1959 Renewed as per certificate: 2019-G1-0672 of 12 Apr. 20192/26/2018RT9360810/15/201910/15/2022Non ?-lactam: Tablets (Coated and Uncoated)Non ?-lactam: Tablets (Coated and Uncoated)Non ?-lactam: Tablets (Coated and Uncoated)NoneNasser Lubowa10/15/2022
287IRF/F/026/02/2019 and IRF/F/033/02/2020 055/GMP/2020 GMP Cert dateCadila Pharmaceuticals Limited1389 Trasad Road, Dolka 38225, Dist Ahmedabad , Gujarat State, IndiaIndiaLicense no. G/1500 and G/1050 form No. 25 & 28 respectively valid up to 20226/27/2018RT975339/25/20199/25/2022Non-beta lactam (Human), Cephalosporins (Human)Non-beta lactam (Human): Small Volume liquid injectables in Vials and ampoules
SVP powder (Lyophilisates)
Tablets
Hard gelatin capsules
, Cephalosporins (Human): SVP powder in Vials
Oral dry powder for suspension Tablets
Hard Gelatin Capsules
Non-beta lactam (Human): Small Volume liquid injectables in Vials and ampoules
SVP powder (Lyophilisates)
Tablets
Hard gelatin capsules
, Cephalosporins (Human): SVP powder in Vials
Oral dry powder for suspension Tablets
Hard Gelatin Capsules
NoneMs. Annette .B. Ssenkindu and Kenneth Kiiza9/25/2022
288IRF/F/034/02/2020 GMP Cert No. 120/GMP/2021Macleods Pharmaceuticals Limited, Unit VIVillage Theda, Kharuni Lodhi Majra Rd, Tehsil Baddi N2, District Solan, Himachal Pradesh – 174101, IndiaIndiaMB/07/593 and MNB/07/594: Validity: 09th June 20223/29/2019RT10838811/12/201911/12/2022Non-beta LactamNon-beta Lactam: Tablets (Coated and uncoated), Hard gelatin capsules, Oral liquids Non-beta Lactam: Tablets (Coated and uncoated), Hard gelatin capsules, Oral liquids NoneAnnet Ssekindu11/12/2022
289IRF/F/035/02/2020 GMP Cert No. 118/GMP/2021Baroque Pharmaceuticals Private LimitedSokhada -387 620 Ta: Khambahat, Dist: Anand (Guj) - IndiaIndiaLicence no.G/1217 (Form 25) and G/890 (Form 28) valid up to 11/03/2020, issued by the Food and Drugs Control Administration - Gandhinagar Gujarat State, India1/16/2019RT10591511/5/201911/5/2022General, Cephalosporin, PenicillinGeneral: Tablets
Hard gelatin capsules
, Cephalosporin: Tablets
Hard gelatin capsules
Powder for oral suspension, Penicillin: Tablets
Hard gelatin capsules
Powder for oral suspension
General: Tablets
Hard gelatin capsules
, Cephalosporin: Tablets
Hard gelatin capsules
Powder for oral suspension, Penicillin: Tablets
Hard gelatin capsules
Powder for oral suspension
NoneAnnet Ssekindu11/5/2022
290IRF/F/036/02/2020 080/GMP/2020 GMP Cert No.Acme Formulations Private LimitedRopar Road, Nalagarh, Distt. Solan , Himachal Pradesh -174 101; Baddi, IndiaIndiaMNB/05/101 (25) and MB/05/102 (28)2/1/2019RT10658711/15/201911/15/2022Non Beta lactam - Hormonal, Non Beta lactamNon Beta lactam - Hormonal: Tablets, Non Beta lactam: Hard gelatin capsulesNon Beta lactam - Hormonal: Tablets, Non Beta lactam: Hard gelatin capsulesNoneAnnet Ssekindu11/15/2022
291IRF/F/039/02/2020 GMP Cert No. 079/GMP/2021Oxalis LabsVillage Theda, P.O. Lodhimajra, Tehsil Baddi, Distt. Solan (H.P.) Pin Code: 174101, IndiaIndiaMNB/11/847 & MB/11/848, Validity 06/03/20228/29/2019RT1160179/24/20199/24/2022Non-beta lactamNon-beta lactam: Tablets (coated and uncoated), External semi-solids (creams, ointments & liquids), Metered Dose InhalersNon-beta lactam: Tablets (coated and uncoated), External semi-solids (creams, ointments & liquids), Metered Dose InhalersNoneLukwago Mohammad9/24/2022
292IRF/F/040/02/2020 Cert No.: 025/GMP/2020Glenmark Pharmaceuticals LimitedPlot No. 2, Phase-II, Pharma zone, Indore Special Economic Zone, Pithampur, Dist. Dhar(M.P.),Pincode 454775 IndiaIndia25/9/2010 valid up to 30/04/2020 issued by Food and Drugs Administration-Madhya Pradesh11/13/2018RT10302211/12/201911/12/2022Non-beta lactam, ImmunosuppressantNon-beta lactam: Tablets (film coated), Capsules hard gelatin. Immunosuppressant: Semi Solids; Ointments and CreamsNon-beta lactam: Tablets (film coated), Capsules hard gelatin. Immunosuppressant: Semi Solids; Ointments and CreamsNoneAmos Mulera Atumanya11/12/2022
293IRF/F/041/02/2020 GMP Cert No. 107/GMP/2020Medreich Limited – Unit IIIPlot 4/3, Avalahalli,Anjanapura Post, Off Kanakapura Road, Bangalore – 560062, Karnataka IndiaIndiaForm 25 KTK/25/169/84 Form 28 KTK/28/101/84 valid up to 31/12/2021 issued by Government of Karnataka Drugs Control Department3/14/2019RT10734711/15/201911/15/2022Non-beta lactamNon-beta lactam: Tablets (Coated & Uncoated)Non-beta lactam: Tablets (Coated & Uncoated)NoneAmos Mulera Atumanya11/15/2022
294IRF/F/042/02/2020 101/GMP/2020 GMP Cert No.Middle East Pharmaceutical Industries Company Limited (Avalon Pharma)2nd Industrial City Riyadh, Saudi Arabia P.O.Box 4180,Riyadh 11491Saudi Arabia01-01-00005 valid until 18/12/44H3/25/2019RT10823811/24/201911/24/2022Non-beta lactamNon-beta lactam: Tablets, Hard gelatin capsules, Semi solids (Ointments, Creams, Gels, Lotions), Pressurized Nasal spray solutionNon-beta lactam: Tablets, Hard gelatin capsules, Semi solids (Ointments, Creams, Gels, Lotions), Pressurized Nasal spray solutionNoneVictoria Kwesiga11/24/2022
295IRF/F/043/02/2020 GMP Cert No. 083/GMP/2021Amriya Pharmaceutical IndustriesAmriya- Alexandria Cairo desert road Km 25, Alexandria, EgyptEgyptLicence No (1) for year 1988.Valid until when revoked7/9/2019RT113771, RT11932311/12/201911/12/2022Non-beta lactamNon-beta lactam: Tablets
Hard Shell Capsules
Suppositories
Semi solids (Creams, ointments and Gels)
Small volume parenteral Liquids (aseptically filled and terminally sterilized)
Liquids for Inhalation
Liquids for internal use
Non-beta lactam: Tablets
Hard Shell Capsules
Suppositories
Semi solids (Creams, ointments and Gels)
Small volume parenteral Liquids (aseptically filled and terminally sterilized)
Liquids for Inhalation
Liquids for internal use
NoneVictoria Kwesiga11/12/2022
296IRF/F/044/02/2020 GMP Cert No. 305/GMP/2020Orchidia Pharmaceutical IndustriesAl Obour City Industrial zone,Area 14,15 Plot No.12011 Cairo - EgyptEgyptSerial No:00035/2018 No.4 ,2009 valid until when revoked9/4/2019RT116201 / RT11620211/7/201911/7/2022Non-beta lactam (Human)Non-beta lactam (Human): Aseptically prepared sterile products (Ophthalmic solutions)Non-beta lactam (Human): Aseptically prepared sterile products (Ophthalmic solutions)NoneVictoria Kwesiga11/7/2022
297IRF/F/045/02/2020 GMP Cert No. 279/GMP/2020Cadila Healthcare LimitedKudaim Industrial Estate Plot No. 203-213 Kudaim Goa 403 115 Goa, IndiaIndiaLicense no. 357/MFG/DFDA/2018/1632 valid up to 31/12/20222/25/2019RT1073129/20/20199/20/2022Non-beta lactam (Human)Non-beta lactam (Human): Tablets (coated and uncoated), Hard gelatin CapsuleNon-beta lactam (Human): Tablets (coated and uncoated), Hard gelatin CapsuleNoneKenneth Kiiza9/20/2022
298IRF/F/046/02/2020 GMP Cert No. 060/GMP/2020Gennova Biopharmaceuticals LimitedBlock 1, Plot No. P-1 & P-2, ITBT Park, Phase II, MIDC, Hinjawadi, Pune-411057IndiaForm 28-D PD/Vacc-6 valid up to 13/11/2021 issued by Food and Drug Administration Maharashtra State, Pune, India9/12/2019FU19/163 - RT11621511/19/201911/19/2022Biologicals, Non – Beta LactamBiologicals: Small volume liquids (Vials & prefilled syringes) - Aseptically prepared, Lyophilised Powders vials, Non – Beta Lactam: Small volume liquids (Terminally sterilized)Biologicals: Small volume liquids (Vials & prefilled syringes) - Aseptically prepared, Lyophilised Powders vials, Non – Beta Lactam: Small volume liquids (Terminally sterilized)NoneAmos Mulera Atumanya11/19/2022
299IRF/F/047/02/2020 Cert No. 030/GMP/2020Glenmark Pharmaceuticals LimitedPlot No. S - 7, Colvale Industrial Estate, Colvale, Bardez 403513, Goa, IndiaIndiaForm 25 No. 648 valid up to 30/04/2020 issued by Directorate of Food & Drugs Administration - Goa11/13/2018RT10302111/22/201911/22/2022Non-beta lactamNon-beta lactam: Tablets (Coated & Uncoated), Hard Gelatin Capsules, Semi Solids; Gels, Ointments and CreamsNon-beta lactam: Tablets (Coated & Uncoated), Hard Gelatin Capsules, Semi Solids; Gels, Ointments and CreamsNoneAmos Mulera Atumanya11/22/2022
300IRF/F/048/02/2020 GMP Cert No. 049/GMP/2021Khandelwal Laboratories Pvt. LimitedB-1, Wagle Industrial Estate, Thane - 400604, IndiaIndia(25) KD/485; and (28) KD/349 granted on 13/12/2001 issued by Food and Drug Administration (Maharashtra state) renewed for 13/12/2016 to 12/12/2021.1/8/2019RT1056909/20/20199/20/2022OncologyOncology: Tablets,Capsules hard gelatin, Small volume parenteral solutions filled in glass ampoules and vials, Lyophilizates (freeze dried injectables)Oncology: Tablets,Capsules hard gelatin, Small volume parenteral solutions filled in glass ampoules and vials, Lyophilizates (freeze dried injectables)NoneSsali Peter9/20/2022
301IRF/F/049/02/2020 053/GMP/2020 GMP Cert No.Zeiss Pharma Limited (Unit II)IGP, SIDCO, Phase II, Samba, Jammu - 184121, (J&K), IndiaIndiaJK/02/16-17/232 valid up to 17/04/2021, issued by the Office of the Controller, Drug and Food Control Organization (J&K) (Jammu)1/8/2019RT105700 RT1056999/17/20199/17/2022CephalosporinCephalosporin: Tablet, Sterile Powder for Injection (in glass vials), Powder for Oral SuspensionCephalosporin: Tablet, Sterile Powder for Injection (in glass vials), Powder for Oral SuspensionNoneSsali Peter9/17/2022
302IRF/F/049/02/2020 211/GMP/2020 GMP Cert No.Zim Laboratories LimitedB-21/22, MIDC Area, Kalmeshwar – 441501, Dist. Nagpur 441501, Maharashtra State, IndiaIndia(28) 1036 granted on 30/04/1993 renewed for the period 01/01/2018 to 31/12/2022; and (25) 1224 granted on 30/04/1993 renewed for the period 01/01/2018 to 31/12/2022 issued by the Food and Drug Administration (Maharashtra State).1/17/2019RT105996 / RT1168409/25/20199/25/2022Non-beta lactam and cephalosporin, Non-beta lactamNon-beta lactam and cephalosporin: Tablet, Capsule, hard gelatin, Dry powder for oral suspension, Non-beta lactam: Orally disintegrating stripNon-beta lactam and cephalosporin: Tablet, Capsule, hard gelatin, Dry powder for oral suspension, Non-beta lactam: Orally disintegrating stripNoneSsali Peter9/25/2022
303IRF/F/052/02/2020 GMP Cert No. 051/GMP/2020Jerusalem Pharmaceutical Company LimitedBalsam Veterinary and Agricultural Branch, Al-Bireh Nablus Road, Al-Bireh – Ramallah Industrial Zone – Birzeit, Palestine. P.O. Box: 3570Palestine214/15 valid from 01 January 2019 to 31st December 201912/14/2018RT1043748/22/20198/22/2022Oral Liquids, Oral powders in sachets. Sterile injectable solution in vialsOral Liquids, Oral powders in sachets. Sterile injectable solution in vialsOral Liquids, Oral powders in sachets. Sterile injectable solution in vialsNoneEAC Team8/22/2022
304IRF/F/053/02/2020 GMP Cert No. 059/GMP/2020Jerusalem Pharmaceutical Company LimitedAl-Bireh Ramallah Industrial Zone, Al-Bireh Nablus Road, P.O. Box: 3570 PalestinePalestine214/2/RNot yet paidNot yet paid8/20/20198/20/2022Sterile Liquid Injection in Ampoules, Sterile Liquid Eye, Nose, Ear drops, Creams, Liquids (Solutions and Suspensions), Suppositories, Capsules, Dry suspensions, TabletsSterile Liquid Injection in Ampoules, Sterile Liquid Eye, Nose, Ear drops, Creams, Liquids (Solutions and Suspensions), Suppositories, Capsules, Dry suspensions, TabletsSterile Liquid Injection in Ampoules, Sterile Liquid Eye, Nose, Ear drops, Creams, Liquids (Solutions and Suspensions), Suppositories, Capsules, Dry suspensions, TabletsNoneEAC Team8/20/2022
305IRF/F/054/02/2020 GMP Cert No. 035/GMP/2020Boehringer Ingelheim Pharma GmbH and Company KGBinger Straße 173, 55216 Ingelheim am Rhein, GermanyGermanyDE_RP_01_MIA_2018_0008 issued by Landesamt für Soziales, Jugend und Versorgung (Rheinland-Pfalz), issued on 27th February 2018, open validity7/19/2019RT11414412/13/201912/13/2022Non-beta lactamNon-beta lactam: Aseptically prepared solutions for inhalation (Respimat), Soft gelatin capsulesNon-beta lactam: Aseptically prepared solutions for inhalation (Respimat), Soft gelatin capsulesNoneOnen Solomon L.12/13/2022
306IRF/F/055/02/2020 GMP Cert No. 036/GMP/2020Corden Pharma GmbHOtto-Hahn Strasse, 68723 Plankstadt- GermanyGermanyDE_BW_01_MIA_2019 0050/DE_BW_01_Corden Pharma; issued by the local (German) drug regulatory authority (Regierungspräsidium Tübingen Leitstelle Arzneimittelüberwachung, Baden-Württemberg), valid until 21.06.20222/25/2019RT107348, RT10725312/6/201912/6/2022Oncology, HormonesOncology: Tablets, Hormones: TabletsOncology: Tablets, Hormones: TabletsNoneOnen Solomon L.12/6/2022
307IRF/F/058/03/2020 GMP Cert No. 037/GMP/2020Shantha Biotechnics Private Limited (A Sanofi Company)SEZ, Sy. No. 354, Muppireddypally Village, Toopran Mandal, Medak (Dist) – 502 236), Telangana - IndiaIndiaLicense No. 01/MD/TS/2015/V/G issued 09.12.2015 valid up to 09.12.2020 issued by the Department of Drugs Control Administration, Hyderabad; Government of Telangana5/17/2018RT962219/6/20199/6/2022VaccineVaccine: Small Volume Parenteral Solution, in glass vialsVaccine: Small Volume Parenteral Solution, in glass vialsNoneAndrew Okello Okonye9/6/2022
308IRF/F/060/03/2020 GMP Cert No. 077/GMP/2020Hebei Yuanzheng Pharmaceutical Company LimitedNo.16 Liuyuan Road Chang’an District Shijiazhuang city-050041, Hebei Province P.R ChinaChinaVeterinary Drug Production License No.03001.Valid up to 8th January 2024. Issued by Hebei Animal Husbandry & Veterinary Bureau1/9/2019RT10575210/29/201910/29/2022Non-beta Lactam, Beta lactam (Penicillin)Non-beta Lactam: Tablets
Oral liquids
Oral Powders & Premixes & Granules
Small Volume Liquids (terminally Sterilized)
Large Volume Liquids- solutions- (Gamma radiation sterilized & terminally Sterilized)
Small Volume Powders (Aseptically filled)
, Beta lactam (Penicillin): Small Volume Liquids (Aseptically filled)
Small Volume Powders (Aseptically filled)
Large Volume Liquids (Aseptically filled)
Non-beta Lactam: Tablets
Oral liquids
Oral Powders & Premixes & Granules
Small Volume Liquids (terminally Sterilized)
Large Volume Liquids- solutions- (Gamma radiation sterilized & terminally Sterilized)
Small Volume Powders (Aseptically filled)
, Beta lactam (Penicillin): Small Volume Liquids (Aseptically filled)
Small Volume Powders (Aseptically filled)
Large Volume Liquids (Aseptically filled)
NoneMwesigwa Denis10/29/2022
309IRF/F/061/03/2020 GMP Cert No. 306/GMP/2020European Egyptian Pharmaceutical IndustriesKm 25,Alexandria – Cairo Desert Road,Amriya,Alexandria Egypt.EgyptFM-LPM-02 No1 for the year 2002 with an open validity9/17/2019RT11667211/14/201911/14/2022Non ?-lactamNon ?-lactam: Tablets, Liquids for internal use (Solutions & syrups), Capsules(hard gelatin), Soft gel capsules, Powders/granules in sachets, Liquids for external useNon ?-lactam: Tablets, Liquids for internal use (Solutions & syrups), Capsules(hard gelatin), Soft gel capsules, Powders/granules in sachets, Liquids for external useNoneVictoria Kwesiga11/14/2022
310IRF/F/062/03/2020 100/GMP/2020 GMP Cert No.Pharco B InternationalPharco B International Borg El-Arab 3rd Industrial Zone, Block 18 10,11, Alexandria, EgyptEgyptFM-LPM-02 from the Ministry of Health Egypt with an open validity5/20/2019RT11086611/19/201911/19/2022Beta-lactam (Cephalosporins), Non-beta lactamBeta-lactam (Cephalosporins): Tablets
Hard Gelatin Capsules
Oral Powders for suspension
Sterile powders for injection, Non-beta lactam: Small Volume Parenteral (SVP)
Large Volume Parenteral (LVP)
Water For Injection (WFI)
Beta-lactam (Cephalosporins): Tablets
Hard Gelatin Capsules
Oral Powders for suspension
Sterile powders for injection, Non-beta lactam: Small Volume Parenteral (SVP)
Large Volume Parenteral (LVP)
Water For Injection (WFI)
NoneVictoria Kwesiga11/19/2022
311005/GMP/2020 DRSchering Plough Labo NVHeist-op-den-Berg BelgiumBelgium304 H5/9/2019FU18/464, RT749741/9/20201/9/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneKaleebu Frank1/9/2023
312013/GMP/2020 DRMedochemie Limited (Cogols Facility)1-10 Constantinoupoleos Street, 3011 Limassol - CyprusCyprus323/23/2018RT94471/RT944721/24/20201/24/2023Non-Beta LactamNon-Beta Lactam: Oral Liquids
Suppositories
Semi-solids
Non-Beta Lactam: Oral Liquids
Suppositories
Semi-solids
NoneKaleebu Frank1/24/2023
313020/GMP/2020 DRInterchemie werken “De Adelaar” B. VMetaalweg 8, 5804 CG Venray, The NetherlandsThe NetherlandsMIA 0640-FGL2/6/2020RT118954, RT1226482/12/20202/12/2023Non-Beta Lactam (Veterinary)Non-Beta Lactam (Veterinary): Oral Liquids
Solid dosage forms (Powders in Sachets)
Non-Beta Lactam (Veterinary): Oral Liquids
Solid dosage forms (Powders in Sachets)
NoneKaleebu Frank2/12/2023
314021/GMP/2020 DRInterchemie Werken "De Adelaar" Eesti ASVanapere tee 14, Puunsi village, 74013 Viimsi, Harjumaa - EstoniaEstoniaMIA 5132/6/2020RT118963, RT1226482/12/20202/12/2023Non-Beta Lactam (Veterinary), Cephalosporin (Veterinary), Penicillins (Veterinary)Non-Beta Lactam (Veterinary): Small Volume Liquids
Large Volume Liquids
, Cephalosporin (Veterinary): Small Volume Liquids
Large Volume Liquids
, Penicillins (Veterinary): Small Volume Liquids
Large Volume Liquids
Non-Beta Lactam (Veterinary): Small Volume Liquids
Large Volume Liquids
, Cephalosporin (Veterinary): Small Volume Liquids
Large Volume Liquids
, Penicillins (Veterinary): Small Volume Liquids
Large Volume Liquids
NoneKaleebu Frank2/12/2023
315026/GMP/2020 DREurofins Lancaster Laboratories Inc.2425 New Holland pike, Pennsylvania, 17601 - United StatesUnited States Of America1/13/2020RT1215452/21/20202/21/2023Vaccines (ERVEBO)Vaccines (ERVEBO): SVP Liquids in vialsVaccines (ERVEBO): SVP Liquids in vialsNoneKaleebu Frank2/21/2023
316027/GMP/2020 DRBioReliance Corporation9900 Blackwell Road, Rockville Maryland 20850 - 3349 - United StatesUnited States Of America1/13/2020RT1215442/21/20202/21/2023Vaccines (ERVEBO)Vaccines (ERVEBO): SVP Liquids in vialsVaccines (ERVEBO): SVP Liquids in vialsNoneKaleebu Frank2/21/2023
317028/GMP/2020 DRBioReliance Corporation9610 Medical Center Drive, Rockville Maryland 20850 - 3349 - United States United States Of America1/13/2020RT1215432/21/20202/21/2023Vaccines (ERVEBO)Vaccines (ERVEBO): SVP Liquids in vialsVaccines (ERVEBO): SVP Liquids in vialsNoneKaleebu Frank2/21/2023
318029/GMP/2020 DRMSD Site – Burgwedel Biotech GmbHIm Langen Felde 5, 30938 Burgwedel - GermanyGermanyDE_NI_02_MIA_2019_00301/13/2020RT1215422/21/20202/21/2023Vaccines (ERVEBO)Vaccines (ERVEBO): SVP Liquids in vialsVaccines (ERVEBO): SVP Liquids in vialsNoneKaleebu Frank2/21/2023
319034/GMP/2020 DREsapharm s.r.l.Via A. De Gasperi, 13 20066 Melzo (Milan) - Italy.ItalyaM 101/20177/31/2019RT114758 / RT1145352/25/20202/25/2023Non-Beta LactamNon-Beta Lactam: Semi - SolidsNon-Beta Lactam: Semi - SolidsNoneKaleebu Frank2/25/2023
320IRF/F/065/05/2020 GMP Cert No. 046/GMP/2020Haupt Pharma Amareg GmbHDonaustaufer Str. 378, D-93055 Regensburg- GermanyGermanyDE_BY_05_MIA_2018_0034/55.2-2678.1-2-72-3 issued by the District government of Upper Franconia (Regierung von Oberfranken), issued on 12th June 20184/12/2019RT10938712/17/201912/17/2022OncologyOncology: Hard gelatin capsulesOncology: Hard gelatin capsulesNoneOnen Solomon L.12/17/2022
321IRF/F/066/05/2020 GMP Cert No. 108/GMP/2020Fresenius Kabi Deutschland GmbHFreseniusstraße 1, 61169 Friedberg, DeutschlandGermanyDE_HE_01_MIA_2018_0094/II 23.2 18I 18.01/1198-B issued by Regierungspräsidium Darmstadt (Renewed 02nd November 2018) open validity3/26/2019RT9770912/10/201912/10/2022Non- Beta LactamNon- Beta Lactam: Small volume liquids Terminally sterilized, Large volume liquids Terminally sterilizedNon- Beta Lactam: Small volume liquids Terminally sterilized, Large volume liquids Terminally sterilizedNoneOnen Solomon L.12/10/2022
322044/GMP/2020 DRSanofi Winthrop Industrie TOURS30-36 Avenue Gustave Eiffel 37100 Tours FranceFranceM12/295/31/2019RT1113295/19/20205/19/2023Non- Beta LactamNon- Beta Lactam: TabletsNon- Beta Lactam: TabletsNoneKaleebu Frank5/19/2023
323058/GMP/2020 DRSchering – Plough Labo nvIndustriepark 30 – Zone A, 2220 Heist-op-den-Berg - BelgiumBelgium304H5/9/2019FU18/464, RT749746/5/20206/5/2023Non- Beta LactamNon- Beta Lactam: Tablets
Creams
Ointments
Liquids for external use
Oral liquids
Small volume liquids
Non- Beta Lactam: Tablets
Creams
Ointments
Liquids for external use
Oral liquids
Small volume liquids
NoneKaleebu Frank6/5/2023
324IRF/F/068/06/2020 GMP Cert No. 062/GMP/2020IPR Pharmaceuticals, Inc. Canóvanas Tablet facility 2 (CTF2)State Road No.188, Lot 17 San Isidro Industrial Park Canóvanas, Puerto Rico 00729Puerto RicoNo. 492626 from Government of Puerto Rico, Department of Health issued on 20th June 20197/9/2017RT873672/11/20202/11/2023Non- Beta LactamNon- Beta Lactam: Tablets (Coated and Uncoated)Non- Beta Lactam: Tablets (Coated and Uncoated)NoneNasser Lubowa2/11/2023
325IRF/F/070/06/2020 GMP Cert No. 282/GMP/2020Indchemie Health Specialties Private LimitedThana, Baddi, District : Solan, Himachal Pradesh - 173 205IndiaMNB/05/132 and MB/05/1332/7/2019RT106797 / RT11034111/19/201911/19/2022Beta Lactam (Penicillin, Cephalosporin), Non Beta LactamBeta Lactam (Penicillin, Cephalosporin): Tablets, Dry powder for oral suspension. Non Beta Lactam: Ointment Beta Lactam (Penicillin, Cephalosporin): Tablets, Dry powder for oral suspension. Non Beta Lactam: Ointment NoneAnnet Ssekindu11/19/2022
326IRF/F/071/06/2020 GMP Cert No. 117/GMP/2021Emcure Pharmaceuticals Pvt. LimitedPlot No. P-2 ITBT Park, Phase II, MIDC, Hinjwadi, Pune-411057, Maharashtra State-IndiaIndia25-PD/149 ; Valid from 04.09.2018 to 03.09.20231/23/2019RT10618011/8/201911/8/2022General (Non Beta Lactam)General (Non Beta Lactam): Tablets, Hard gelatin capsulesGeneral (Non Beta Lactam): Tablets, Hard gelatin capsulesNoneAnnet Ssekindu11/8/2022
327063/GMP/2020 EAC InspectionBoehringer Ingelheim Animal HealthS.P.A. Via Baviera 9, Noventa Padova, Padova, Italy - 35027Italy5/24/2019RT11114310/25/201910/25/2022Inactivated and live, Viral and bacterial Veterinary VaccinesInactivated and live, Viral and bacterial Veterinary Vaccines: Small Volume Parenterals (Solution and Lyophilized powders for suspension), Large Volume Parenterals (Solution and Lyophilized powders for suspension)Inactivated and live, Viral and bacterial Veterinary Vaccines: Small Volume Parenterals (Solution and Lyophilized powders for suspension), Large Volume Parenterals (Solution and Lyophilized powders for suspension)NoneAmoreen Naluyima10/25/2022
328064/GMP/2020 EAC InspectionElanco Animal Health also known as Lohmann Animal Health GmbHHenz-Lohmann-Strasse 4, 27472 Cuxhaven; Lower Saxony, Federal Republic of GermanyGermany23.12-4211/1-10LAH, valid until 14/11/20194/10/2019RT10924610/29/201910/29/2022Live attenuated and inactivated Viral Veterinary vaccines, Live attenuated and inactivated Bacterial Veterinary vaccinesLive attenuated and inactivated Viral Veterinary vaccines: Small Volume Parenterals (Solution and Lyophilized powders for suspension), Live attenuated and inactivated Bacterial Veterinary vaccines: Small Volume Parenterals (Solution and Lyophilized powders for suspension)Live attenuated and inactivated Viral Veterinary vaccines: Small Volume Parenterals (Solution and Lyophilized powders for suspension), Live attenuated and inactivated Bacterial Veterinary vaccines: Small Volume Parenterals (Solution and Lyophilized powders for suspension)NoneAmoreen Naluyima10/29/2022
329069/GMP/2020 DRUnither Liquid Manufacturing1-3, allee de la Neste – Z.I d’ en Sigal 31770 Colomiers - FranceFranceM 16/0846/8/2020FU19/5776/24/20206/24/2023Non-Beta LactamNon-Beta Lactam: Liquids for external use, Oral Liquids, Suppositories
Non-Beta Lactam: Liquids for external use, Oral Liquids, Suppositories
NoneKaleebu Frank6/24/2023
330070/GMP/2020 DRBayer OyOfficial address: P.O Box 415 FI-20101 Turku, Street address: Pansionatie 47 FIN-20210Turku, FinlandFinland1303/06.08.00.04/20183/17/2020FU19/4836/29/20206/29/2023HormonesHormones: Solids and implants, Intra uterine devicesHormones: Solids and implants, Intra uterine devicesNoneKaleebu Frank6/29/2023
331071/GMP/2020 DRDelorbis Pharmaceuticals Limited17, Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia – CyprusCyprusO333/5/2020RT1245626/30/20206/30/2023Non-Beta LactamNon-Beta Lactam: Tablets, Hard gelatin capsulesNon-Beta Lactam: Tablets, Hard gelatin capsulesNoneKaleebu Frank6/30/2023
332IRF/F/072/07/2020 GMP Cert No. 091/GMP/2020Veteria Labs S.A. (Inosan Biopharma S.A.)Lucerna, Plot No.7.Col - Juarez CP 06600,Del Cuauhtemoc Mexico D.F, MexicoMexico09 006 01 0001 issued on 15 March 2018 by COFEPRIS, Mexico6/1/2018RT967022/14/20202/14/2023Biological immunological products- Polyvalent Snake Anti-venomsBiological immunological products- Polyvalent Snake Anti-venoms: Large Volume Parenteral Solutions (in LDPE bags) – Aseptically preparedBiological immunological products- Polyvalent Snake Anti-venoms: Large Volume Parenteral Solutions (in LDPE bags) – Aseptically preparedNoneNasser Lubowa2/14/2023
333IRF/F/073/07/2020 GMP cert No. 286/GMP/2020Zoetis2000 Rockford Road, Charles City, Iowa 50616-9101, USAUnited States Of America190 Issued by the United States Department of Agriculture and renewed on 3rd October 20186/30/2017RT847212/25/20202/25/2023Biological products- Live /Inactivated Viral and Bacterial Poultry VaccinesBiological products- Live /Inactivated Viral and Bacterial Poultry Vaccines: Small Volume Liquids (Packaged in Glass Ampoules and Vials) – Aseptically prepared, Large Volume Liquids (Packaged Glass Vials and HDPE Bottles) – Aseptically prepared, Small Volume Parenteral Lyophilized Powders (Packaged in Glass Vials) – Aseptically preparedBiological products- Live /Inactivated Viral and Bacterial Poultry Vaccines: Small Volume Liquids (Packaged in Glass Ampoules and Vials) – Aseptically prepared, Large Volume Liquids (Packaged Glass Vials and HDPE Bottles) – Aseptically prepared, Small Volume Parenteral Lyophilized Powders (Packaged in Glass Vials) – Aseptically preparedNoneNasser Lubowa2/25/2023
334IRF/F/074/07/2020 GMP Cert No. 287/GMP/2020Lohmann Animal Health International (A subsidiary of Elanco Animal Health)Plot 375 China Road, Winslow, Maine 04901, USAUnited States Of America196 Issued by the United States Department of Agriculture and renewed on 21st March 20197/13/2018RT977402/21/20202/21/2023Biological products- Live /Inactivated Viral and Bacterial Poultry VaccinesBiological products- Live /Inactivated Viral and Bacterial Poultry Vaccines: Small Volume Liquids (Packaged in Glass Ampoules and Vials) – Aseptically prepared, Large Volume Liquids (Packaged Glass Vials and HDPE Bottles) – Aseptically prepared, Small Volume Parenteral Lyophilized Powders (Packaged in Glass Vials) – Aseptically preparedBiological products- Live /Inactivated Viral and Bacterial Poultry Vaccines: Small Volume Liquids (Packaged in Glass Ampoules and Vials) – Aseptically prepared, Large Volume Liquids (Packaged Glass Vials and HDPE Bottles) – Aseptically prepared, Small Volume Parenteral Lyophilized Powders (Packaged in Glass Vials) – Aseptically preparedNoneNasser Lubowa2/21/2023
335075/GMP/2020 GMP Cert No (EAC Inspection by Tanzania and Burundi)Ajanta Pharma LimitedMirza - Palashbari Road, Village - Kokjhar, Palashbari – 781128 Kamrup (R. Assam) IndiaIndiaForm 25 vide License No. 394/DR/Mfg./2017 and Form 28 vide License No. 395/DR/Mfg./2017 valid up to January 2022 by State Food and Drugs Administration of Assam, India11/15/2018RT103076, RT943755/3/20195/3/2022Non-Beta LactamNon-Beta Lactam: Tablets (Coated and Uncoated)
Hard Gelatin Capsules
Oral Gels
Semi-solids (Creams, Lotions and Ointments)
Non-Beta Lactam: Tablets (Coated and Uncoated)
Hard Gelatin Capsules
Oral Gels
Semi-solids (Creams, Lotions and Ointments)
NoneTanzania5/3/2022
336083/GMP/2020 DRRottendorf Pharma GmbHOstenfelder Strasse 51-61 Ennigerloh - GermanyGermanyDE_NW_06_MIA_2019_00086/11/2019RT106771, RT127638, RT1276397/30/20207/30/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneKaleebu Frank7/30/2023
337084/GMP/2020 DRNovartis Farma S.p.AVia Provinciale Schito 131,80058 Torre Annunziata - ItalyItalyaM – 11/20196/5/2020FU19/5707/30/20207/30/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneKaleebu Frank7/30/2023
338085/GMP/2020 DRLek S. A.Domaniewska Str. 50 C, 02-672 Warsaw - PolandPoland064/0095/154/29/2020FU19/5207/30/20207/30/2023Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
NoneKaleebu Frank7/30/2023
339086/GMP/2020 DRGlaxoSmithKline Dungarvan LimitedKnockbrack, Dungarvan, Co. Waterford – IrelandIreland4775/14/2020FU19/5367/30/20207/30/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneKaleebu Frank7/30/2023
340087/GMP/2020 DRF. Hoffmann – La Roche KaiseraugstWurmisweg CH – 4303 Basel – SwitzerlandSwitzerland4/15/2020RT125710, FU19/5107/30/20207/30/2023Biotechnology Products, CephalosporinBiotechnology Products: SVP Liquids in Vials
SVP Lyophilisates
Prefilled Syringes
, Cephalosporin: SVP Powders in Vials
Biotechnology Products: SVP Liquids in Vials
SVP Lyophilisates
Prefilled Syringes
, Cephalosporin: SVP Powders in Vials
NoneKaleebu Frank7/30/2023
341088/GMP/2020 DRRottendorf Pharma GmbHAm Fleigendahl 3, 59320 Ennigerloh – GermanyGermanyDE_NW_06_MIA_2019_00086/11/2019RT106771, RT127638, RT1276397/30/20207/30/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneKaleebu Frank7/30/2023
342089/GMP/2020 DRAllphamed PHARBIL Arzneimittel GmbHHildebrandstr. 10-12, 37081 Gottingen – GermanyGermany6/10/2019RT1116327/30/20207/30/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneKaleebu Frank7/30/2023
343IRF/F/075/08/2020 GMP Cert No. 003/GMP/2021PT. Sanbe Farma Sterile preparation plant - (Unit 3)Jalan Industri Cimareme No. 8 Desa Cimareme, Kecamatan Padalarang, Kabupaten Bandung Barat 40553 - IndonesiaIndonesiaLicense No. HK.07.IF/V/402/14 -- Open validity9/10/2018RT1012103/6/20203/6/2023Non-Beta LactamNon-Beta Lactam: SVP Liquids (Aseptically filled), SVP Liquids (Terminally sterilized), SVP dry powders (Aseptically filled), LVP liquids (terminally sterilized)Non-Beta Lactam: SVP Liquids (Aseptically filled), SVP Liquids (Terminally sterilized), SVP dry powders (Aseptically filled), LVP liquids (terminally sterilized)NoneWilberforce Kwiringira3/6/2023
344IRF/F/077/08/2020 GMP Cert No. 331/GMP/2020PT. Sanbe Farma Unit 1Jalan Industri I No. 9 RT. 01 RW.08, Kelurahan Utama, Kecamatan Cimahi Selatan, Kota Cimahi 40553 - IndonesiaIndonesia4922/CPOB/A/II/17 – Validity 6 March 20229/10/2018RT1012083/3/20203/3/2023Non-Beta LactamNon-Beta Lactam: Hard gelatin capsulesNon-Beta Lactam: Hard gelatin capsulesNoneWilberforce Kwiringira3/3/2023
345092/GMP/2020 DRSanofi Pasteur (Swiftwater)1 Discovery Drive, Swiftwater, PA, 18370 - United States of AmericaUnited States Of AmericaFEI 25187606/12/2019RT1117148/11/20208/11/2023Vaccines (Menactra)Vaccines (Menactra): Small Volume LiquidsVaccines (Menactra): Small Volume LiquidsNoneKaleebu Frank8/11/2023
346093/GMP/2020 DRAbic Biological Laboratories Limited3 Hamelacha st., West Industrial zone, Beit-Shemesh 9905503 - IsraelIsrael17/9/2020RT1293838/11/20208/11/2023VaccinesVaccines: Large Volume Liquids, SVP Liquids in Vials, SVP Lyophilisates, TabletsVaccines: Large Volume Liquids, SVP Liquids in Vials, SVP Lyophilisates, TabletsNoneKaleebu Frank8/11/2023
347094/GMP/2020 DRAbbVie Deutschland GmbH & Company KG50 Knollstrasse, D-67061, Ludwigshafen - GermanyGermanyDE_RP_01_MIA_2020_00347/30/2020RT1300758/11/20208/11/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneKaleebu Frank8/11/2023
348095/GMP/2020 DRFARMACLAIR440, Avenue du General de Gaulle 14200 Herouville-Saint Clair - FranceFranceM13/1715/28/2020FU19/559, RT977228/11/20208/11/2023Non-Beta LactamNon-Beta Lactam: Oral Liquids, Oral SuspensionsNon-Beta Lactam: Oral Liquids, Oral SuspensionsNoneKaleebu Frank8/11/2023
349098/GMP/2020 DRLek S. A.Podlipie Str. 16, 95-010 Stryykow - PolandPoland064/0095/154/29/2020FU19/5198/21/20208/21/2023Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
NoneKaleebu Frank8/21/2023
350IRF/F/078/08/2020 GMP Cert No. 008/GMP/2021PT. Tunggal Idaman Abdi, Plant 2JI. Jenderal. Ahmad Yani No.7, Jakarta Timur – 13230 Indonesia Latitude: 6.205071 Longitude: 106.874006 - IndonesiaIndonesia5350/CPOB/A/III/19 Validity- 14/04/20243/11/2019RT1077153/10/20203/10/2023HormonesHormones: Small volume liquids (Aseptically filled)Hormones: Small volume liquids (Aseptically filled)NoneWilberforce Kwiringira3/10/2023
351102/GMP/2020 DRMerck Serono S.A., AubonneZone Industrielle de I’Ouriettaz, CH-1170 Aubonne, SwitzerlandSwitzerland511442-1026163703/27/2020RT1264639/24/20209/24/2023Biotechnology ProductsBiotechnology Products: Small Volume Liquids, SVP Lyophilisates in Pre-filled Syringes & Catridges
Biotechnology Products: Small Volume Liquids, SVP Lyophilisates in Pre-filled Syringes & Catridges
NoneKaleebu Frank9/24/2023
352103/GMP/2020 DRMaropack AGIndustrie Strasse 4 CH 6144 Zell Lu - SwitzerlandSwitzerland5071162/13/2020RT1234019/24/20209/24/2023HormonesHormones: Semi-solids (Creams, Ointments & Gels)Hormones: Semi-solids (Creams, Ointments & Gels)NoneKaleebu Frank9/24/2023
353104/GMP/2020 DRCatalent Germany Schorndorf GmbHSteinbeisstrasse 1 und 2, Schorndorf, Baden-Wuerttemberg, 73614, GermanyGermanyDE_BW_01_MIA_2019_01187/22/2020RT1297409/24/20209/24/2023Non-Beta LactamNon-Beta Lactam: Hard Gelatin CapsulesNon-Beta Lactam: Hard Gelatin CapsulesNoneKaleebu Frank9/24/2023
354105/GMP/2020 DRGSK Consumer Health SAGSK Consumer Health SA, Route De L’etraz, Nyon, 1260, SwitzerlandSwitzerland5055276/30/2020RT1290839/24/20209/24/2023Non-Beta LactamNon-Beta Lactam: Liquids for External use
Oral Liquids
Semi-solids (Creams, Gels & Ointments)
Non-Beta Lactam: Liquids for External use
Oral Liquids
Semi-solids (Creams, Gels & Ointments)
NoneKaleebu Frank9/24/2023
355106/GMP/2020 DRGenetech Inc1 DNA Way, South San Franscisco CA 94080 United States of AmericaUnited States Of America406622/15/2019RT1070609/24/20209/24/2023BiologicalsBiologicals: Small Volume LiquidsBiologicals: Small Volume LiquidsNoneKaleebu Frank9/24/2023
356110/GMP/2020 CCIncepta Pharmaceuticals LimitedDewan Idris Road, Bara Rangamatia, Zirabo, Ashulia, Savar, Dhaka, BangladeshBangladesh3/27/2018RT94552, RT945519/25/20209/25/2023Sterile products (Non Beta-lactam), Non-Sterile products (Non Beta-lactam), Beta-lactam (Cephalosporin) (Unit 4), Biologicals (Unit 10), Vaccines (Vaccine plant)Sterile products (Non Beta-lactam): Lyophilized (SVP) powder (Unit 6)
Small Volume Parenteral (SVP) Powder
(Unit 1 and 3)
Large Volume Parenteral (LVP) Solution (Unit 1 and 3)
Small Volume Parenteral (SVP) Solution (Unit 1 and 3)
Eye/Ear drops, Non-Sterile products (Non Beta-lactam): Oral liquid (Unit 5)
Tablets (Unit 1 and 3)
Hard gelatin Capsules (Unit 3)
Granules (Unit 1)
External liquids (Unit 5)
Creams and ointments (Unit 5), Beta-lactam (Cephalosporin) (Unit 4): Tablets
Capsules
Dry Powder for suspension
SVP powders, Biologicals (Unit 10): Insulin in vials and Cartridges, Vaccines (Vaccine plant): Typhoid Polysaccharide
Tetanus toxoid
Hepatitis
Purified rabies vaccine
Immunoglobin tetanus and rabies
Sterile products (Non Beta-lactam): Lyophilized (SVP) powder (Unit 6)
Small Volume Parenteral (SVP) Powder
(Unit 1 and 3)
Large Volume Parenteral (LVP) Solution (Unit 1 and 3)
Small Volume Parenteral (SVP) Solution (Unit 1 and 3)
Eye/Ear drops, Non-Sterile products (Non Beta-lactam): Oral liquid (Unit 5)
Tablets (Unit 1 and 3)
Hard gelatin Capsules (Unit 3)
Granules (Unit 1)
External liquids (Unit 5)
Creams and ointments (Unit 5), Beta-lactam (Cephalosporin) (Unit 4): Tablets
Capsules
Dry Powder for suspension
SVP powders, Biologicals (Unit 10): Insulin in vials and Cartridges, Vaccines (Vaccine plant): Typhoid Polysaccharide
Tetanus toxoid
Hepatitis
Purified rabies vaccine
Immunoglobin tetanus and rabies
NoneDenis William Mwesigwa9/25/2023
357111/GMP/2020 CCKivi Pharm Co., Limited (formerly Hebei Kaiwei Pharmaceutical Co. Limited)No. 5 Hangtian Street, Dongshan High-tech Industrial Development Zone, Shalingzi Town, Xuanhua County, Zhangjiakou City, Hebei Province Peoples Republic of ChinaChina4/26/2018RT95559 / RT955609/25/20209/25/2023Non Beta-lactamNon Beta-lactam: Small volume parenteral (Aseptically prepared packed in Ampoules)Non Beta-lactam: Small volume parenteral (Aseptically prepared packed in Ampoules)NoneDenis William Mwesigwa9/25/2023
358112/GMP/2020 CCNectar Lifesciences LimitedUnit-VI, Village – Bhatolikalan, Adjoining Jharmajri, Post: Barotiwala, Tehsil – Baddi, Dist-Solan, H.P. – 173205, IndiaIndia6/18/2018RT971519/25/20209/25/2023Beta Lactam
(Cephalosporin)
Beta Lactam
(Cephalosporin): Dry Powders for injection (SVP)
Tablets
Hard Gelatin Capsules
Dry powders for oral suspension
Beta Lactam
(Cephalosporin): Dry Powders for injection (SVP)
Tablets
Hard Gelatin Capsules
Dry powders for oral suspension
NoneDenis William Mwesigwa9/25/2023
359113/GMP/2020 CCShanghai Gongyi Veterinary Medicines PlantNo. 298, Huancheng East Road, Fengxian County, Shanghai - China China6/25/2018RT97387/RT97288/RT974099/25/20209/25/2023Beta-Lactam (Penicillin), Non-Beta LactamBeta-Lactam (Penicillin): Small volume parenteral liquids for veterinary use
Sterile powders for injection for veterinary use
Premixes and soluble oral powders for veterinary use, Non-Beta Lactam: Small volume parenteral solutions for veterinary use
Oral liquids for veterinary use
Beta-Lactam (Penicillin): Small volume parenteral liquids for veterinary use
Sterile powders for injection for veterinary use
Premixes and soluble oral powders for veterinary use, Non-Beta Lactam: Small volume parenteral solutions for veterinary use
Oral liquids for veterinary use
NoneDenis William Mwesigwa9/25/2023
360114/GMP/2020 CCGlaxoSmithKline Consumer Healthcare S.A (Pty) Limited39 Hawkins Avenue, Epping Industria 1, 7460, Cape Town, South AfricaSouth Africa7/18/2018RT993719/25/20209/25/2023Non-Beta LactamNon-Beta Lactam: Tablets
Powders for Oral Solution
Non-Beta Lactam: Tablets
Powders for Oral Solution
NoneDenis William Mwesigwa9/25/2023
361115/GMP/2020 COctober PharmaPlot 190, 1st Industrial zone, 6th October City, Cairo - EgyptEgypt8/1/2018RT977399/28/20209/28/2023Non-Beta LactamNon-Beta Lactam: Oral Tablets
Oral Capsules
Oral Liquids (Syrup & Suspension)
Topical Solutions
Non-Beta Lactam: Oral Tablets
Oral Capsules
Oral Liquids (Syrup & Suspension)
Topical Solutions
NoneDenis William Mwesigwa9/28/2023
362116/GMP/2020 CCSouth Egypt Drug Industries Company (SEDICO)First Industrial Zone, 6th of October City - EgyptEgypt12/11/2018RT1042079/28/20209/28/2023Non-Beta Lactam, Biologicals (SVP), Beta Lactam (Penicillin)Non-Beta Lactam: Oral Veterinary Powders
Tablets
Powders for Oral Suspension
Hard Gelatin Capsules
Oral Liquids
Ointments, Creams & Gels
Suppositories
Sterile liquids in Ampoules
Powder Sachets
Small volume Liquids (Aseptically prepared in plastic Ampoule)
Small volume Lyophilized Powder (Aseptically prepared)
Soft Gelatin Capsules
, Biologicals (SVP): Recombinant Insulin
Urokinase
Streptokinase
Erythropoietin
, Beta Lactam (Penicillin): Sterile Powder for injection – SVP Dry Powder
Powders for Oral Suspension
Hard Gelatin Capsules
Tablets
Non-Beta Lactam: Oral Veterinary Powders
Tablets
Powders for Oral Suspension
Hard Gelatin Capsules
Oral Liquids
Ointments, Creams & Gels
Suppositories
Sterile liquids in Ampoules
Powder Sachets
Small volume Liquids (Aseptically prepared in plastic Ampoule)
Small volume Lyophilized Powder (Aseptically prepared)
Soft Gelatin Capsules
, Biologicals (SVP): Recombinant Insulin
Urokinase
Streptokinase
Erythropoietin
, Beta Lactam (Penicillin): Sterile Powder for injection – SVP Dry Powder
Powders for Oral Suspension
Hard Gelatin Capsules
Tablets
NoneDenis William Mwesigwa9/28/2023
363117/GMP/2020 CCSandoz Grup Saglik Urunleri llaclari Sanayi ve Ticaret A.S.Gebze 2 GOSB Ihsan Dede Cad. 900 Sok 41480 Gebze Kocaeli - TurkeyTurkey2/28/2019JV10/7649/28/20209/28/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa9/28/2023
364118/GMP/2020 CCAmoun Pharmaceutical Company1st Industrial Zone A, Plot Nos. 1B, 2, 3, 4, 5 Block 13015, El-Obour City, Kalyoubia Cairo - EgyptEgypt3/11/2019RT1077329/28/20209/28/2023Non-Beta LactamNon-Beta Lactam: Hard Gelatin Capsules
Soft Gelatin Capsules
Tablets (Coated & Uncoated)
Dry powders for suspension
Powders packed in sachets
Small Volume Parenteral (Aseptically prepared Liquids)
Small Volume Parenteral – (Aseptically prepared Powders)
Eye drops (Aseptically Prepared)
Oral Liquids
Non-sterile Nasal drops
External semi-solids (Creams & Gels)
Topical Sprays
External Solutions
Oral Veterinary Solutions & Powders
Non-Beta Lactam: Hard Gelatin Capsules
Soft Gelatin Capsules
Tablets (Coated & Uncoated)
Dry powders for suspension
Powders packed in sachets
Small Volume Parenteral (Aseptically prepared Liquids)
Small Volume Parenteral – (Aseptically prepared Powders)
Eye drops (Aseptically Prepared)
Oral Liquids
Non-sterile Nasal drops
External semi-solids (Creams & Gels)
Topical Sprays
External Solutions
Oral Veterinary Solutions & Powders
NoneDenis William Mwesigwa9/28/2023
365119/GMP/2020 CCPharco PharmaceuticalsKm 31, Alexandria / Cairo desert road Amriya, Alexandria - EgyptEgypt3/26/2019RT1045219/28/20209/28/2023Beta Lactam
(penicillin),
Non-Beta Lactam
Beta Lactam
(penicillin): Oral dry powders for suspension
Hard Gelatin Capsules
Tablets
SVP Powders (Vials),
Non-Beta Lactam: Oral dry powders (Human & Veterinary)
Hard Gelatin Capsules
Tablets
Oral Liquids
Oral Powders in sachets
Small volume Liquids (Aseptically prepared)
Creams, Ointments, Gels,
Suppositories, Pessaries & Ovules
Beta Lactam
(penicillin): Oral dry powders for suspension
Hard Gelatin Capsules
Tablets
SVP Powders (Vials),
Non-Beta Lactam: Oral dry powders (Human & Veterinary)
Hard Gelatin Capsules
Tablets
Oral Liquids
Oral Powders in sachets
Small volume Liquids (Aseptically prepared)
Creams, Ointments, Gels,
Suppositories, Pessaries & Ovules
NoneDenis William Mwesigwa9/28/2023
366121/GMP/2020 CCAmman Pharmaceutical IndustriesKing Abdullah Industrial City, Sahab, Amman - JordanJordan4/2/2019RT108486 / RT1084879/28/20209/28/2023Non-Beta LactamNon-Beta Lactam: Sterile Eye drops (Aseptically prepared)
Sterile Eye ointments (Aseptically prepared)
Non-sterile Nasal drops
Non-sterile Metered dose nasal sprays
Ointments, Creams & Lotions
Non-Beta Lactam: Sterile Eye drops (Aseptically prepared)
Sterile Eye ointments (Aseptically prepared)
Non-sterile Nasal drops
Non-sterile Metered dose nasal sprays
Ointments, Creams & Lotions
NoneDenis William Mwesigwa9/28/2023
367122/GMP/2020 CCAgog Pharma LimitedPlot No. 33, Sector II, The Vasai Taluka Indl. Co-op. Estate Limited, Gauraipada, Vasai (E). Dist. Thane 401 208, India India2/14/2020RT123415 (Paid 8000Usd)9/28/20209/28/2023Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin capsules
Creams, Lotions & Ointments
Oral rehydration salts
Powders for oral suspension
Oral liquids for internal use
External solutions
Non-Beta Lactam: Tablets
Hard Gelatin capsules
Creams, Lotions & Ointments
Oral rehydration salts
Powders for oral suspension
Oral liquids for internal use
External solutions
NoneDenis William Mwesigwa9/28/2023
368123/GMP/2020 CCJubilant Generics Limited (Formerly Jubilant Life Sciences Limited)Village Sikandarpur Bhainswal Roorkee Dehradun Highway Bhagwanpur, Roorkee Distt - Haridwar, Uttarakhand 247661 - IndiaIndia3/29/2019RT848199/28/20209/28/2023Non-Beta LactamNon-Beta Lactam: Tablets (Coated & Uncoated), Hard Gelatin capsulesNon-Beta Lactam: Tablets (Coated & Uncoated), Hard Gelatin capsulesNoneDenis William Mwesigwa9/28/2023
369124/GMP/2020 CCKotra Pharma (M) Sdn. BhdNo. 1, 2 & 3 Jalan TTC 12, Cheng Industrial Estate, 75250, Melaka– Malaysia Malaysia4/29/2019RT110248, RT1102499/28/20209/28/2023Non-Beta Lactam, (Beta Lactam) Cephalosporin, Corticosteroids Non-Beta Lactam: Tablets Coated & Uncoated
Hard gelatin capsules
Oral Liquids
SVP liquids and powder
Sterile gels
, (Beta Lactam) Cephalosporin: Hard gelatin capsules
Dry powder for oral suspension
SVP powder
, Corticosteroids: Ointments and Creams
Non-Beta Lactam: Tablets Coated & Uncoated
Hard gelatin capsules
Oral Liquids
SVP liquids and powder
Sterile gels
, (Beta Lactam) Cephalosporin: Hard gelatin capsules
Dry powder for oral suspension
SVP powder
, Corticosteroids: Ointments and Creams
NoneDenis William Mwesigwa9/28/2023
370125/GMP/2020 CCCeva Sante Animale10, avenue de la Ballastiere, 33500 Libourne - FranceFrance4/26/2019RT1101899/28/20209/28/2023Non-Beta Lactam, Beta Lactam (Penicillin), Secondary PackagingNon-Beta Lactam: SVP Solutions and Suspensions
Lyophilized Powders (Powders/Granules for injection)
Reproductive Hormonal Devices
, Beta Lactam (Penicillin): SVP Solutions and Suspensions
Lyophilized Powders (Powders/Granules for injection)
, Secondary Packaging: Vaccines
Non-Beta Lactam: SVP Solutions and Suspensions
Lyophilized Powders (Powders/Granules for injection)
Reproductive Hormonal Devices
, Beta Lactam (Penicillin): SVP Solutions and Suspensions
Lyophilized Powders (Powders/Granules for injection)
, Secondary Packaging: Vaccines
NoneDenis William Mwesigwa9/28/2023
371126/GMP/2020 CCGracure Pharmaceuticals LimitedE-1105, RIICO Industrial Area, Phase III, Bhiwadi, Alwar District, Rajasthan, 301019 - India India4/25/2019RT1101649/28/20209/28/2023Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Creams and ointments
Oral liquids
Dry powders for oral suspension
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
Creams and ointments
Oral liquids
Dry powders for oral suspension
NoneDenis William Mwesigwa9/28/2023
372127/GMP/2020 CCGlaxoSmithKline (Kenya) LimitedIndustrial Area, Likoni Road, P.O. Box 78392-00507, Nairobi - KenyaKenya4/24/2019RT1099339/28/20209/28/2023Non-Beta LactamNon-Beta Lactam: Tablets
Oral Liquids
Oral Powders in Sachets
Non-Beta Lactam: Tablets
Oral Liquids
Oral Powders in Sachets
NoneDenis William Mwesigwa9/28/2023
373128/GMP/2020 CCMega Lifesciences Public Company Limited, Plant 2515/1 Soi 8, Pattana 3 Road, Bangpoo Industrial Estate, Samutprakarn 10280 - ThailandThailand4/24/2019RT1101559/28/20209/28/2023Non-Beta LactamNon-Beta Lactam: Soft Gelatin Capsules
Tablets (coated and uncoated)
Hard Gelatin Capsules
Oral powder in sachets
Non-Beta Lactam: Soft Gelatin Capsules
Tablets (coated and uncoated)
Hard Gelatin Capsules
Oral powder in sachets
NoneDenis William Mwesigwa9/28/2023
374129/GMP/2020 CCMega Lifesciences Public Company Limited, Plant 1384 Soi 6, Pattana 3 Road, Bangpoo Industrial Estate, Samutprakarn 10280 - ThailandThailand4/24/2019RT1101549/28/20209/28/2023Non-Beta LactamNon-Beta Lactam: Soft Gelatin CapsulesNon-Beta Lactam: Soft Gelatin CapsulesNoneDenis William Mwesigwa9/28/2023
375130/GMP/2020 CCMilan Laboratories (India) Private LimitedPlot Nos. 35, 36, 63, 64, 65, 67 & 87 Jawahar Co-op. Industrial Estate Limited. Kamothe, Panvel (Navi Mumbai) District Raigad, 410209 - IndiaIndia4/9/2019RT1092189/28/20209/28/2023Non-Beta Lactam, Beta Lactam (Penicillin)Non-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Powders for oral suspension
Oral Liquids
Creams & Ointments
, Beta Lactam (Penicillin): Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Powders for oral suspension
Non-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Powders for oral suspension
Oral Liquids
Creams & Ointments
, Beta Lactam (Penicillin): Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Powders for oral suspension
NoneDenis William Mwesigwa9/28/2023
376131/GMP/2020 CCHovid Berhad121, Jalan Tunku Abdul Rahman (Jalan Kuala Kangsar), 30010 Ipoh Perak - MalaysiaMalaysia4/11/2019RT1093529/28/20209/28/2023Beta Lactam (Penicillin), Non-Beta LactamBeta Lactam (Penicillin): Tablets
Hard Gelatin Capsules
Granules (oral dry powders for reconstitution)
, Non-Beta Lactam: Oral Liquids for internal use
Soft Gelatin Capsules
Creams, Ointments, Lotions & Gels
Beta Lactam (Penicillin): Tablets
Hard Gelatin Capsules
Granules (oral dry powders for reconstitution)
, Non-Beta Lactam: Oral Liquids for internal use
Soft Gelatin Capsules
Creams, Ointments, Lotions & Gels
NoneDenis William Mwesigwa9/28/2023
377132/GMP/2020 CCHovid BerhadLot 56442, 7 1/2 Miles Jalan Ipoh/ Chemor 31200 Chemor, Perak - MalaysiaMalaysia4/11/2019RT1093539/28/20209/28/2023Non-Beta Lactam, (Primary & Secondary Packaging only)Non-Beta Lactam: Tablets (Coated and Uncoated)
Hard Gelatin Capsules
Granules (Powders in sachets), Soft Gelatin Capsules, (Primary & Secondary Packaging only): Soft Gelatin Capsules
Non-Beta Lactam: Tablets (Coated and Uncoated)
Hard Gelatin Capsules
Granules (Powders in sachets), Soft Gelatin Capsules, (Primary & Secondary Packaging only): Soft Gelatin Capsules
NoneDenis William Mwesigwa9/28/2023
378133/GMP/2020 CCIpca Laboratories LimitedPlot No. 69-72(B), Sector-II Kandla Special Economic Zone (KASEZ), Gandhidham – 370230, Gujarat - IndiaIndia5/27/2019RT1112189/28/20209/28/2023Beta Lactam (Penicillin)Beta Lactam (Penicillin): Tablets
Hard gelatin capsules.
Dry powder for suspension
Beta Lactam (Penicillin): Tablets
Hard gelatin capsules.
Dry powder for suspension
NoneDenis William Mwesigwa9/28/2023
379134/GMP/2020 DRJanssen Cilag SpAVia C. Janssen, Borgo S Michele 04100, Latina - ItalyItaly5/27/2019RT1111829/28/20209/28/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa9/28/2023
380135/GMP/2020 DRLek Pharmaceuticals ddVerovskova 5, SI – 1526 Ljubliana - SloveniaSlovenia6/8/2018RT958809/30/20209/30/2023Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Liquids (Nasal sprays)
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
Liquids (Nasal sprays)
NoneDenis William Mwesigwa9/30/2023
381136/GMP/2020 CCAstra Lifecare (India) Private Limited57/P, Sarkhej-Bavla Highway, Post Rajoda-382220, Taluka-Bavla, Dist: Ahmedabad, Gujarat - IndiaIndia6/6/2019RT1115049/30/20209/30/2023Non-Beta Lactam, Beta Lactam (Penicillin)Non-Beta Lactam: Tablets (Except Sugar Coated tablets)
Hard Gelatin Capsules
, Beta Lactam (Penicillin): Tablets
Hard Gelatin Capsules (Except Cloxacillin Sodium Capsules)
Non-Beta Lactam: Tablets (Except Sugar Coated tablets)
Hard Gelatin Capsules
, Beta Lactam (Penicillin): Tablets
Hard Gelatin Capsules (Except Cloxacillin Sodium Capsules)
NoneDenis William Mwesigwa9/30/2023
382137/GMP/2020 CCIPCA Laboratories LimitedP.O Sejavta Dist. Ratlam-457002, Madhya Pradesh - IndiaIndia6/20/2019RT1112199/30/20209/30/2023Non-Beta LactamNon-Beta Lactam: Tablets
Oral Liquids
SVP Liquids in Vials and Ampoules (Aseptic filling and terminally sterilized)
Non-Beta Lactam: Tablets
Oral Liquids
SVP Liquids in Vials and Ampoules (Aseptic filling and terminally sterilized)
NoneDenis William Mwesigwa9/30/2023
383138/GMP/2020 CCCooper K BrandsMashiara Park, Kaptagat Road, off Waiyaki road Nairobi, KenyaKenya6/25/2019RT1122399/30/20209/30/2023Vaccines, Non-Beta Lactam, Ecto-parasiticidesVaccines: LVPs, Non-Beta Lactam: Tablets (boluses), Creams & Ointments(milk salve), Oral Liquids (Drenches), Ecto-parasiticides: External LiquidsVaccines: LVPs, Non-Beta Lactam: Tablets (boluses), Creams & Ointments(milk salve), Oral Liquids (Drenches), Ecto-parasiticides: External LiquidsNoneDenis William Mwesigwa9/30/2023
384139/GMP/2020 CCHebei Jiheng (Group) Pharmaceutical Company LimitedNo. 368 Jianshe Street, Hengshui City, Hebei Province, 053000 - P. R. ChinaChina6/25/2019RT1122199/30/20209/30/2023Non-Beta LactamNon-Beta Lactam: Tablets (Paracetamol)Non-Beta Lactam: Tablets (Paracetamol)NoneDenis William Mwesigwa9/30/2023
385140/GMP/2020 CCReckitt Benckiser Healthcare Manufacturing (Thailand) Limited65 Moo 12, Lardkrabang - Bangplee Road Bang Phli Yai, Bang Phli 10540 Samut Prakan - ThailandThailand7/10/2019RT1138039/30/20209/30/2023Non-Beta LactamNon-Beta Lactam: Medicated and Non-medicated lozengesNon-Beta Lactam: Medicated and Non-medicated lozengesNoneDenis William Mwesigwa9/30/2023
386141/GMP/2020 CCLincoln Parenteral Limited11, Trimul Estate, Near Khatraj Chokadi, P. O. Khatraj 382721 Ta: Kalol, Dist. Gandhinagar, Gujarat - IndiaIndia7/15/2019RT1140079/30/20209/30/2023Non-Beta LactamNon-Beta Lactam: Small Volume Parenteral solutions
Small Volume Parenteral powders
Oral liquids
Non-Beta Lactam: Small Volume Parenteral solutions
Small Volume Parenteral powders
Oral liquids
NoneDenis William Mwesigwa9/30/2023
387142/GMP/2020 CCNorbrook Laboratories LimitedFactory Number 4 Carnbane Industrial Estate, NEWRY, BT35 6QQ, Co Down, Northern Ireland–United KingdomUnited Kingdom7/23/2019RT1142559/30/20209/30/2023Non-Beta LactamNon-Beta Lactam: Vet PremixesNon-Beta Lactam: Vet PremixesNoneDenis William Mwesigwa9/30/2023
388143/GMP/2020 CCNorbrook Laboratories LimitedFactory Number 3 105 Armagh Road, NEWRY, BT35 6PU, Co. Down, Northern Ireland–United KingdomUnited Kingdom7/23/2019RT1142549/30/20209/30/2023Beta Lactam, Non-Beta LactamBeta Lactam: LVP Liquids, Non-Beta Lactam: Large Volume Parenteral Liquids
Small Volume Parenteral Liquids
Liquids for External use
Beta Lactam: LVP Liquids, Non-Beta Lactam: Large Volume Parenteral Liquids
Small Volume Parenteral Liquids
Liquids for External use
NoneDenis William Mwesigwa9/30/2023
389144/GMP/2020 CCNorbrook Laboratories LimitedFactory No. 1 station Works, NEWRY, BT35 6JP, Co Down, Northern Ireland, Northern Ireland - United KingdomUnited Kingdom4/23/2019RT1099009/30/20209/30/2023Beta Lactam, Non-Beta LactamBeta Lactam: Tablets
Large Volume Parenteral Liquids
Sterile solids & Implants
, Non-Beta Lactam: Semi-solids
Large Volume Parenteral Liquids
Beta Lactam: Tablets
Large Volume Parenteral Liquids
Sterile solids & Implants
, Non-Beta Lactam: Semi-solids
Large Volume Parenteral Liquids
NoneDenis William Mwesigwa9/30/2023
390145/GMP/2020 CCPharaonia Pharmaceuticals (Pharo Pharma)3rd Industrial zone, Block 16, New Burg El Arab, Alexandria- EgyptEgypt7/26/2019RT114385 / RT1126059/30/20209/30/2023Non-Beta LactamNon-Beta Lactam: Sterile Eye drops
Small volume liquids in Ampoules, Tablets
Hard Gelatin Capsules
Oral Powders in sachets
Oral dry powders
Creams, Ointments & Gels
Suppositories
Oral Syrup & Suspension
Oral drops, Nasal drops & Otic drops
Topical Solutions
Non-Beta Lactam: Sterile Eye drops
Small volume liquids in Ampoules, Tablets
Hard Gelatin Capsules
Oral Powders in sachets
Oral dry powders
Creams, Ointments & Gels
Suppositories
Oral Syrup & Suspension
Oral drops, Nasal drops & Otic drops
Topical Solutions
NoneDenis William Mwesigwa9/30/2023
391146/GMP/2020 CCOlive Healthcare, Unit 1197/2, Athiawad, Dabhel Village, Nani Daman, Daman 396210 - IndiaIndia8/1/2019RT114820 / RT1148219/30/20209/30/2023Non-Beta LactamNon-Beta Lactam: Soft Gelatin CapsulesNon-Beta Lactam: Soft Gelatin CapsulesNoneDenis William Mwesigwa9/30/2023
392147/GMP/2020 CCInd Swift LimitedIndustrial Growth Centre, Phase 1, SIDCO Samba, Jammu & Kashmir, 184121 - IndiaIndia8/5/2019RT1148899/30/20209/30/2023Non-Beta LactamNon-Beta Lactam: Tablets (Coated & Uncoated
Powders for Oral Suspension
Non-Beta Lactam: Tablets (Coated & Uncoated
Powders for Oral Suspension
NoneDenis William Mwesigwa9/30/2023
393148/GMP/2020 CCIntas Pharmaceuticals LimitedPlot No. 457-458 & 191/218P, Sarkhej-Bavla Highway, Matoda 382 210 (Gujarat) Ta. Sanand, Ahmedabad, Gujarat - India India8/6/2019RT1149929/30/20209/30/2023Non-Beta Lactam, OncologyNon-Beta Lactam: Tablets
Hard gelatin capsules
Small volume liquids in ampoules and vials
, Oncology: Tablets
Hard gelatin capsules
Small volume (solutions and lyophilized powders)
Non-Beta Lactam: Tablets
Hard gelatin capsules
Small volume liquids in ampoules and vials
, Oncology: Tablets
Hard gelatin capsules
Small volume (solutions and lyophilized powders)
NoneDenis William Mwesigwa9/30/2023
394149/GMP/2020 CCAhlcon Parenterals (India) LimitedSP-917-918, Phase III, Ind. Area, Bhiwadi-301019, Dist. Alwar (Rajasthan) - IndiaIndia8/7/2019RT1150169/30/20209/30/2023Non-Beta LactamNon-Beta Lactam: Eye/Ear drops
Nebulizers
Large Volume Parenterals
Small Volume Parenterals
Non-Beta Lactam: Eye/Ear drops
Nebulizers
Large Volume Parenterals
Small Volume Parenterals
NoneDenis William Mwesigwa9/30/2023
395150/GMP/2020 CCUni-med (India) LimitedUni-Med House, 86, Marol C-op. Industrial Estate, M.V. Road, Marol, Mumbai, 400 059 - IndiaIndia8/15/2019RT1155069/30/20209/30/2023Non-Beta LactamNon-Beta Lactam: Tablets (coated and uncoated)
Capsules (hard gelatin)
Oral liquids and suspensions
Non-Beta Lactam: Tablets (coated and uncoated)
Capsules (hard gelatin)
Oral liquids and suspensions
NoneDenis William Mwesigwa9/30/2023
396151/GMP/2020 CCMedopharm, IndiaNo. 34-B, Industrial Area, Malur - 563 160, Karnataka, IndiaIndia8/21/2019RT1124699/30/20209/30/2023Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
NoneDenis William Mwesigwa9/30/2023
397152/GMP/2020 CCBharat Biotech International LtdGenome Valley, Shameerpet Mandal, Medchal District - 500 078, Telangana IndiaIndia8/26/2019RT115756 / RT1157579/30/20209/30/2023Non-Beta LactamNon-Beta Lactam: Small Volume Parenteral liquids packed in ampoules, prefilled syringes and vials
Small Volume Parenterals (lyophilized) packed in vials
Topical ointments
Oral powders packed in Sachets
Recombinant hepatitis-B vaccine
Thiomerosal free hepatitis-B vaccine,
Comvac 3 (diphtheria, tetanus and pertussis vaccine)
Comvac 4 (diphtheria, tetanus, pertussis and Hepatitis-B vaccine),
Comvac 5(Diphtheria, Tetanus, Pertussis, Hepatitis-B and Haemophilis influenza type b)
Rotavirus vaccine (Rotavac), Rabies vaccine (Indirab), Typhoid vaccine (TYPBAR),
Typhoid conjugate vaccine (TYPBAR TCV),
Haemophilus influenza Type B –PRP conjugate vaccine (BioHib)
Lyophilized Rabies vaccine (Indirab)
Prefilled syringes of Typhoid vaccine (TYPBAR),
Prefilled syringes Typhoid conjugate vaccine (TYPBAR TCV),
Haemophilus influenza Type B –PRP conjugate vaccine (BioHib)
Regen D 60
Regen D 150
Slvrgen
Flora Norm
Non-Beta Lactam: Small Volume Parenteral liquids packed in ampoules, prefilled syringes and vials
Small Volume Parenterals (lyophilized) packed in vials
Topical ointments
Oral powders packed in Sachets
Recombinant hepatitis-B vaccine
Thiomerosal free hepatitis-B vaccine,
Comvac 3 (diphtheria, tetanus and pertussis vaccine)
Comvac 4 (diphtheria, tetanus, pertussis and Hepatitis-B vaccine),
Comvac 5(Diphtheria, Tetanus, Pertussis, Hepatitis-B and Haemophilis influenza type b)
Rotavirus vaccine (Rotavac), Rabies vaccine (Indirab), Typhoid vaccine (TYPBAR),
Typhoid conjugate vaccine (TYPBAR TCV),
Haemophilus influenza Type B –PRP conjugate vaccine (BioHib)
Lyophilized Rabies vaccine (Indirab)
Prefilled syringes of Typhoid vaccine (TYPBAR),
Prefilled syringes Typhoid conjugate vaccine (TYPBAR TCV),
Haemophilus influenza Type B –PRP conjugate vaccine (BioHib)
Regen D 60
Regen D 150
Slvrgen
Flora Norm
NoneDenis William Mwesigwa9/30/2023
398153/GMP/2020 CCNorbrook Kenya LimitedOld Limuru Road, Karuri, Kiambu - KenyaKenya8/28/2019RT1159159/30/20209/30/2023Non-Beta Lactam (Vet)Non-Beta Lactam (Vet): Tablets (boluses)
Oral liquids (drenches)
Creams & ointments (Milking salve)
External liquids (Ectoparasiticides) – Primary and Secondary Packaging
Non-Beta Lactam (Vet): Tablets (boluses)
Oral liquids (drenches)
Creams & ointments (Milking salve)
External liquids (Ectoparasiticides) – Primary and Secondary Packaging
NoneDenis William Mwesigwa9/30/2023
399154/GMP/2020 CCGlenmark Pharmaceuticals Limited (Unit-II)Village Bhattanwala, P.O. Rajpura, Nalagarh Distt. Solan Himachal Pradesh 174101 - IndiaIndia9/2/2019RT1161259/30/20209/30/2023Non-Beta LactamNon-Beta Lactam: Oral Liquids
Lotions
Ointments & Creams
Non-Beta Lactam: Oral Liquids
Lotions
Ointments & Creams
NoneDenis William Mwesigwa9/30/2023
400155/GMP/2020 CCAssociated BiotechVillage: Kishanpura, Gugumajra Road, Baddi The: Nalagarh Himachal Pradesh 174101 - IndiaIndia9/6/2019RT116258 / RT1162599/30/20209/30/2023Non-Beta Lactam, Beta-lactam (Cephalosporin)Non-Beta Lactam: Dry powder for oral suspension
Tablets
Capsules
, Beta-lactam (Cephalosporin): Dry powder for oral suspension
Non-Beta Lactam: Dry powder for oral suspension
Tablets
Capsules
, Beta-lactam (Cephalosporin): Dry powder for oral suspension
NoneDenis William Mwesigwa9/30/2023
401156/GMP/2020 CCAshish Life Science Private LimitedJ-137, M.I.D.C., Tarapur, Boisar, Thane, Boisar 401 501 Tal Palgahr, Dist. Palghar, Maharashtra - IndiaIndia9/10/2019RT116347 / FU19/151 - RT696909/30/20209/30/2023Non-Beta Lactam (Vet)Non-Beta Lactam (Vet): Oral liquids
Oral pastes
Small Volume Parenterals
Tablets
Non-Beta Lactam (Vet): Oral liquids
Oral pastes
Small Volume Parenterals
Tablets
NoneDenis William Mwesigwa9/30/2023
402157/GMP/2020 CCMedicef Pharma28, Phase-1, EPIP, Jharmajri, Baddi, Distt. Solan (H.P) IndiaIndia9/12/2019RT1165589/30/20209/30/2023Beta Lactam (Penicillin)Beta Lactam (Penicillin): Tablets
Dry powder for oral suspension
Beta Lactam (Penicillin): Tablets
Dry powder for oral suspension
NoneDenis William Mwesigwa9/30/2023
403158/GMP/2020 DRLaboratoires Biove3, Rue de Lorraine, 62510 - FranceFrance9/25/2019RT117145, RT1171469/30/20209/30/2023Veterinary Beta Lactam & Non-Beta LactamVeterinary Beta Lactam & Non-Beta Lactam: Small Volume Parenterals
Large Volume Parenterals
Oral Liquids
Oral Powders
Veterinary Beta Lactam & Non-Beta Lactam: Small Volume Parenterals
Large Volume Parenterals
Oral Liquids
Oral Powders
NoneDenis William Mwesigwa9/30/2023
404159/GMP/2020 CCUnichem Laboratories Limited (Unit-II)Village Bhatauli Kalan, The Baddi, Distt. Solan, Himachal Pradesh, 173205 - IndiaIndia10/18/2019RT1180709/30/20209/30/2023Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Soft Gelatin Capsules
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
Soft Gelatin Capsules
NoneDenis William Mwesigwa9/30/2023
405160/GMP/2020 CCEva Pharma for Pharmaceuticals and Medical Appliances S.A.E176 El-Sadat Street, Kafr El-Gabal, Pyramids, Giza Egypt Egypt10/22/2019RT1181819/30/20209/30/2023Non-Beta LactamNon-Beta Lactam: Oral Liquids for internal use
Tablets (Coated and Uncoated)
Hard Gelatin Capsules
Oral powder for suspension
Ointments, Creams and Gels
Non-Beta Lactam: Oral Liquids for internal use
Tablets (Coated and Uncoated)
Hard Gelatin Capsules
Oral powder for suspension
Ointments, Creams and Gels
NoneDenis William Mwesigwa9/30/2023
406161/GMP/2020 CCHebei New Century Pharmaceutical Co. LimitedNo. 189 Taihang Street, Shijiazhuang, Hebei Province, ChinaChina10/28/2019RT11832110/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Oral Liquids
Water Soluble Powders
Small Volume Parenteral liquids
Non-Beta Lactam: Oral Liquids
Water Soluble Powders
Small Volume Parenteral liquids
NoneDenis William Mwesigwa10/1/2023
407162/GMP/2020 CCSakar Healthcare LimitedBlock No. 10-13, Sarkhej-Bavla Highway, Vil: Changodar, Dist: Ahmedabad-382213, Gujarat - IndiaIndia11/18/2019RT116602, FU19/69, RT11930010/1/202010/1/2023Beta Lactam (Both Cephalosporin & Penicillin), Beta Lactam (Cephalosporin), Non-Beta LactamBeta Lactam (Both Cephalosporin & Penicillin): Hard gelatin Capsules
Oral powders for suspension
Tablets
, Beta Lactam (Cephalosporin): Small volume powders for injection, Non-Beta Lactam: Oral liquids
Small volume parenteral liquids
Beta Lactam (Both Cephalosporin & Penicillin): Hard gelatin Capsules
Oral powders for suspension
Tablets
, Beta Lactam (Cephalosporin): Small volume powders for injection, Non-Beta Lactam: Oral liquids
Small volume parenteral liquids
NoneDenis William Mwesigwa10/1/2023
408163/GMP/2020 CCRavian Life Science Pvt. LimitedPlot No. 34, Sector: 8A, SIDCUL, IIE, Haridwar - 249403, Uttarakhand - IndiaIndia10/31/2019RT11853110/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Oral liquids
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
Oral liquids
NoneDenis William Mwesigwa10/1/2023
409164/GMP/2020 CCDar Al Dawa Development and Investment PlantsNa’ur – Prince Hashem Bin Al-Hussein Street, P.O. Box 9364 Amman 11191 - JordanJordan10/31/2019RT11853410/1/202010/1/2023Non-Beta Lactam, Beta lactam
(Penicillin & Cephalosporin)
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
Eye drops and SVP liquids
Oral Liquids
Suppositories
, Beta lactam
(Penicillin & Cephalosporin): Tablets
Hard Gelatin Capsules
Powders for oral suspension
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
Eye drops and SVP liquids
Oral Liquids
Suppositories
, Beta lactam
(Penicillin & Cephalosporin): Tablets
Hard Gelatin Capsules
Powders for oral suspension
NoneDenis William Mwesigwa10/1/2023
410165/GMP/2020 CCEurolife Healthcare LimitedKhasra No. 520, Bhagwanpur, Roorkee, Haridwar - IndiaIndia11/1/2019RT11857210/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: LVP solutions
SVP solutions
Eye drops
Non-Beta Lactam: LVP solutions
SVP solutions
Eye drops
NoneDenis William Mwesigwa10/1/2023
411166/GMP/2020 CCExir Pharmaceutical CompanyFactory: 2nd km of Ring road, Boroujerd, 69189 - IranIran11/4/2019RT11864610/1/202010/1/2023Non-Beta Lactam, Beta lactam (Cephalosporin)Non-Beta Lactam: Oral liquids
Powders for oral suspension
Hard Gelatin Capsules
SVP Solutions and powders
, Beta lactam (Cephalosporin): Tablets
Powders for oral suspension
SVP powders
Non-Beta Lactam: Oral liquids
Powders for oral suspension
Hard Gelatin Capsules
SVP Solutions and powders
, Beta lactam (Cephalosporin): Tablets
Powders for oral suspension
SVP powders
NoneDenis William Mwesigwa10/1/2023
412167/GMP/2020 CCStedman Pharmaceuticals Pvt. LimitedC-4, SIDCO Pharmaceutical Complex, Alathur, Thiruporur - 603110 Kancheepuram District Tamil Nadu - IndiaIndia11/25/2019RT119531, RT11963010/1/202010/1/2023Non-Beta Lactam, Beta lactam (Cephalosporin)Non-Beta Lactam: Tablets (coated and uncoated)
Hard gelatin capsules
Oral powder in sachets
Topical powders
Topical solutions
Ointments/Gels
Oral liquids
Non-Beta Lactam: Tablets (coated and uncoated)
Hard gelatin capsules
Oral powder in sachets
Topical powders
Topical solutions
Ointments/Gels
Oral liquids
NoneDenis William Mwesigwa10/1/2023
413168/GMP/2020 CCSunrise International Labs LimitedPlot No. 100, Lane 5, Sector II, Phase II, IDA Cherlapally, Hyderabad 500051, Telangana - IndiaIndia11/18/2019RT11931710/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Tablets (Coated and Uncoated)
Hard Gelatin Capsules
Oral liquids
Non-Beta Lactam: Tablets (Coated and Uncoated)
Hard Gelatin Capsules
Oral liquids
NoneDenis William Mwesigwa10/1/2023
414169/GMP/2020 CCBharat Serums and Vaccines LimitedPlot No. K-27, Anand Nagar, Jambivili Village, Additional MIDC, Ambernath (East) - 421501, India Maharashtra IndiaIndia10/14/2019RT117829, RT11782810/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: SVP Liquids Packed in Glass Ampoules & Vials
SVP Lyophilized powders packed in Vials
Non-Beta Lactam: SVP Liquids Packed in Glass Ampoules & Vials
SVP Lyophilized powders packed in Vials
NoneDenis William Mwesigwa10/1/2023
415170/GMP/2020 CCPharmedic Laboratories (Pvt) Limited16-km Multan Road, Lahore - PakistanPakistan11/27/2019RT11960410/1/202010/1/2023Non-Beta Lactam, OncologyNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Powder for oral suspension
Small Volume Parenteral (Solutions in Glass Ampoules)
Small Volume Parenteral (Powder in glass vials)
, Oncology: Small Volume Parenteral (Powder in glass vials)
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
Powder for oral suspension
Small Volume Parenteral (Solutions in Glass Ampoules)
Small Volume Parenteral (Powder in glass vials)
, Oncology: Small Volume Parenteral (Powder in glass vials)
NoneDenis William Mwesigwa10/1/2023
416171/GMP/2020 CCBeta Healthcare International LimitedPlot number LR. 209/6554, Mogadishu Rd, Off Lunga Lunga Road, Industrial Area, P.O. BOX 42569-00100, Nairobi - Kenya Kenya11/27/2019RT11962610/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Tablets (uncoated)
Hard gelatin capsules
Oral liquids
External liquids
Non-Beta Lactam: Tablets (uncoated)
Hard gelatin capsules
Oral liquids
External liquids
Denis William Mwesigwa10/1/2023
417172/GMP/2020 CCAkriti Pharmaceutical Pvt. LimitedD-10/D-11, MIDC, Jejuri-Nira Road, Jejuri, Taluka: Purandhar, Dist-Pune, 412303, Maharashtra - IndiaIndia11/27/2019RT11960910/1/202010/1/2023Non-Beta Lactam, CephalosporinNon-Beta Lactam: Tablets
Hard Gelatin Capsules
, Cephalosporin: Powders for injection
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
, Cephalosporin: Powders for injection
NoneDenis William Mwesigwa10/1/2023
418173/GMP/2020 CCKopran LimitedVillage - Savroli (Khopoli), Taluka – Khalapur, Dist. Raigad 410202, Maharashtra - IndiaIndia11/29/2019RT119702, FU19/30110/1/202010/1/2023Non-Beta Lactam, Beta-Lactam (Penicillin)Non-Beta Lactam: Hard gelatin Capsules
Tablets
, Beta-Lactam (Penicillin): Hard gelatin Capsules
Tablets
Powders for oral suspension
Non-Beta Lactam: Hard gelatin Capsules
Tablets
, Beta-Lactam (Penicillin): Hard gelatin Capsules
Tablets
Powders for oral suspension
NoneDenis William Mwesigwa10/1/2023
419174/GMP/2020 CCXepa-Soul Pattinson (Malaysia) SDN. BHD1-5 Cheng Industrial Estate, 75250, Meleka - MalaysiaMalaysia12/16/2019RT12025810/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Tablets (Coated and Uncoated)
Hard Gelatin Capsules
Sterile eye / ear drops
Oral Liquids
Semi –Solids (Ointments, Creams)
Non-Beta Lactam: Tablets (Coated and Uncoated)
Hard Gelatin Capsules
Sterile eye / ear drops
Oral Liquids
Semi –Solids (Ointments, Creams)
NoneDenis William Mwesigwa10/1/2023
420175/GMP/2020 CCBlue Cross Laboratories Pvt. LimitedA- 12, MIDC Ambad, Nashik - 422010 Maharashtra - IndiaIndia1/3/2020RT12077310/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Tablets
Small volume liquids
Non-Beta Lactam: Tablets
Small volume liquids
NoneDenis William Mwesigwa10/1/2023
421176/GMP/2020 CCLincoln Pharmaceuticals Limited10, 12, 13, Trimul Estate, Near Khatraj Chokadi, P.O. Khatraj-382721 Ta: Kalol, Dist. Gandhinagar, Gujarat IndiaIndia9/23/2019RT113949, RT11685910/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Tablets (coated and uncoated)
Hard gelatin capsules
Powder for oral suspension
Ointments/gels/creams
Non-Beta Lactam: Tablets (coated and uncoated)
Hard gelatin capsules
Powder for oral suspension
Ointments/gels/creams
NoneDenis William Mwesigwa10/1/2023
422177/GMP/2020 CCNabiqasim Industries (Pvt.) Limited17/24, Korangi Industrial Area, Korangi, Karachi PakistanIndia1/22/2020RT120427, RT12199910/1/202010/1/2023Non-Beta Lactam, Beta Lactam, CytotoxicNon-Beta Lactam: Tablet
Hard gelatin Capsule
Small volume Lyophilized powder
Oral liquids (suspension and syrup)
Oral dry powder
External solutions (enema)
Creams
, Beta Lactam: Oral powder - Cephalosporin, Cytotoxic: Tablets, Gels
Non-Beta Lactam: Tablet
Hard gelatin Capsule
Small volume Lyophilized powder
Oral liquids (suspension and syrup)
Oral dry powder
External solutions (enema)
Creams
, Beta Lactam: Oral powder - Cephalosporin, Cytotoxic: Tablets, Gels
NoneDenis William Mwesigwa10/1/2023
423178/GMP/2020 CCBiological E LimitedPlot No. 31 and 32, Pharmacity, Selaqui Industrial Estate, Selaqui, Dehradun, Uttarakhand, India, 248197 - IndiaIndia2/4/2020RT12254910/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Oral LiquidsNon-Beta Lactam: Oral LiquidsNoneDenis William Mwesigwa10/1/2023
424179/GMP/2020 CCSynokem Pharmaceuticals LimitedSynokem Pharmaceuticals Limited, Plot No. 35-36, Sector-6A, IIE, (SIDCUL), Ranipur (BHEL), Haridwar, 249403, (Uttarakhand) - IndiaIndia2/20/2020RT12393110/1/202010/1/2023Non-Beta Lactam (Human), HormonesNon-Beta Lactam (Human): Tablets
Hard Gelatin Capsules
Oral Liquids
, Hormones: Tablets
Non-Beta Lactam (Human): Tablets
Hard Gelatin Capsules
Oral Liquids
, Hormones: Tablets
NoneDenis William Mwesigwa10/1/2023
425180/GMP/2020 CCSichuan Kelun Pharmaceutical Company LimitedSouth of No.2, Xindu Satellite City, Industrial Development Zone, Chengdu Sichuan Province 610500, People’s Republic of ChinaChina2/25/2020RT124029, RT12403010/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Large Volume Parenterals- Glass bottles
Large Volume Parenterals- Polypropylene bottle
Large Volume Parenterals- Non PVC bag & PP Blend infusion bag (Soft bag)
Small Volume Parenterals- Ampoule
Non-Beta Lactam: Large Volume Parenterals- Glass bottles
Large Volume Parenterals- Polypropylene bottle
Large Volume Parenterals- Non PVC bag & PP Blend infusion bag (Soft bag)
Small Volume Parenterals- Ampoule
NoneDenis William Mwesigwa10/1/2023
426181/GMP/2020 CCIndoco Remedies LimitedB - 20, MIDC, Waluj, Aurangabad (Ms) 431136 - IndiaIndia2/25/2020RT12404510/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Oral Liquids
Tablets (Coated & Uncoated)
External Liquids (Mouth wash, Ear drops & Dental paint)
Non-Beta Lactam: Oral Liquids
Tablets (Coated & Uncoated)
External Liquids (Mouth wash, Ear drops & Dental paint)
NoneDenis William Mwesigwa10/1/2023
427182/GMP/2020 CCChongqing Fangtong Animal Pharmaceutical Company LimitedNo. 80 East part of Changzhou road Banqiao Industrial Park Rongchang Chongqing - ChinaChina3/4/2020RT124471. RT12447210/1/202010/1/2023Non-Beta Lactam (Vet), Beta Lactam - Penicillin (Vet)Non-Beta Lactam (Vet): Tablets.
Oral liquids
Small volume parental liquids.
Oral soluble powders in sachets.
External liquids (Acaricides & Disinfectants)
, Beta Lactam - Penicillin (Vet): SVP- powders (Penicillin)
Non-Beta Lactam (Vet): Tablets.
Oral liquids
Small volume parental liquids.
Oral soluble powders in sachets.
External liquids (Acaricides & Disinfectants)
, Beta Lactam - Penicillin (Vet): SVP- powders (Penicillin)
NoneDenis William Mwesigwa10/1/2023
428183/GMP/2020 DRChimac SA26 Rue De Renory B4102 Ougree Serain - BelgiumBelgium3/6/2020RT12459210/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: EctoparasiticidesNon-Beta Lactam: EctoparasiticidesNoneDenis William Mwesigwa10/1/2023
429184/GMP/2020 DRBremer Pharma GmbHWerkstr. 42, 34414, Warburg - GermanyGermany3/9/2020RT12464810/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Intramammary Ointments
Small Volume Parenteral liquids
Powders in sachets and bottles
Non-Beta Lactam: Intramammary Ointments
Small Volume Parenteral liquids
Powders in sachets and bottles
NoneDenis William Mwesigwa10/1/2023
430185/GMP/2020 CCAstraZeneca Pharmaceutical Company LimitedNo. 2 Huangshan Road, Wuxi, Jiangsu, 214028 - ChinaChina3/5/2020RT12456010/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa10/1/2023
431186/GMP/2020 CCTroikaa Pharmaceuticals LimitedC-1 Sara Industrial Estate, Selaqui, Dehradun - 248197, Uttarakhand - IndiaIndia3/24/2020RT126340, FU19/49510/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Tablets (Coated & uncoated)
Hard Gelatin capsules (solid filled & liquid filled)
Small Volume Parenteral liquids (Vials & Ampoules)
Non-Beta Lactam: Tablets (Coated & uncoated)
Hard Gelatin capsules (solid filled & liquid filled)
Small Volume Parenteral liquids (Vials & Ampoules)
NoneDenis William Mwesigwa10/1/2023
432187/GMP/2020 CCSurge Laboratories (Private) Limited10th Km, Faisalabad Road, Bikhi, District Sheikhupura, PakistanPakistan7/23/2020RT12983810/1/202010/1/2023Non-Beta Lactam, Cephalosporin Beta-LactamNon-Beta Lactam: Small Volume Parenteral Solutions (In ampoules), Cephalosporin Beta-Lactam: Small Volume Parenteral (Powders for Injection)Non-Beta Lactam: Small Volume Parenteral Solutions (In ampoules), Cephalosporin Beta-Lactam: Small Volume Parenteral (Powders for Injection)NoneDenis William Mwesigwa10/1/2023
433188/GMP/2020 CCSance Laboratories Private LimitedVI/51B, P.B No. 2, Kozhuvanal, Pala, Kottayam - 686573, Kerala - IndiaIndia5/21/2020RT12686710/1/202010/1/2023Beta lactam (Cephalosporin)Beta lactam (Cephalosporin): Tablets
Dry powders for injection
Hard gelatin capsules
Dry powders for oral suspension
Beta lactam (Cephalosporin): Tablets
Dry powders for injection
Hard gelatin capsules
Dry powders for oral suspension
NoneDenis William Mwesigwa10/1/2023
434189/GMP/2020 CCAjanta Pharma LimitedPlot No. Z/103/A, DAHEJ SEZ Part-II District Bharuch 392130 Gujarat State - IndiaIndia5/18/2020RT126549, FU19/54310/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa10/1/2023
435190/GMP/2020 CCAthena Drug Delivery Solutions Pvt. LimitedPlot No. A1 to A5. MIDC, Chemical Zone, Ambernath (West) 421501 Maharashtra - IndiaIndia5/22/2020RT126894, RT12689510/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Tablets
Capsules (Pellets in Capsules)
Sachets (Pellets/Granules)
Non-Beta Lactam: Tablets
Capsules (Pellets in Capsules)
Sachets (Pellets/Granules)
NoneDenis William Mwesigwa10/1/2023
436191/GMP/2020 CCM & H Manufacturing Company Limited41 Sukhumuvit Road Pakfam, Muang Samut Prakan 10270 - ThailandThailand5/27/2020RT12697510/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Oral powders (Veterinary Premixes)Non-Beta Lactam: Oral powders (Veterinary Premixes)NoneDenis William Mwesigwa10/1/2023
437192/GMP/2020 CCSun Pharmaceutical Industries Limited (Formerly Ranbaxy Laboratories)Village Ganguwala, Paonta Sahib District Sirmour - 173025 (H.P), IndiaIndia5/25/2020RT125386, FU19/55710/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
NoneDenis William Mwesigwa10/1/2023
438193/GMP/2020 CCAurobindo Pharma Limited, Unit-XIISurvey No.: 314, Bachupally, Bachupally (Mandal), Medchal - Malkajgiri District, Hyderabad, Telengana, India. Pin Code - 500 090India6/2/2020RT12722810/1/202010/1/2023Beta LactamBeta Lactam: Tablets
Powders for injection
Hard gelatin capsules
Powders for oral reconstitution
Beta Lactam: Tablets
Powders for injection
Hard gelatin capsules
Powders for oral reconstitution
NoneDenis William Mwesigwa10/1/2023
439194/GMP/2020 CCSinopharm Weiqida Pharamaceutical Company LimitedEconomic & Technological Development Zone, Second Medical Zone, Datong, Shanxi Province - ChinaChina6/5/2020RT12730110/1/202010/1/2023Beta Lactam (Penicillins)Beta Lactam (Penicillins): Tablets (coated and uncoated)
Hard gelatin capsules
SVP- powders
Beta Lactam (Penicillins): Tablets (coated and uncoated)
Hard gelatin capsules
SVP- powders
NoneDenis William Mwesigwa10/1/2023
440195/GMP/2020 CCUni MedicolabsUni Medicolabs, Plot No. 21-22, Pharmacity, Selaqui, Dehradun – 248011, Uttarakhand - IndiaIndia6/10/2020RT127406, RT12740710/1/202010/1/2023Non-Beta Lactam, Beta Lactam (Penicillins)Non-Beta Lactam: Tablets
Hard Gelatin Capsules
, Beta Lactam (Penicillins): Tablets.
Hard Gelatin Capsules.
Oral dry powder for suspension
Small Volume Parenteral (Powders)
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
, Beta Lactam (Penicillins): Tablets.
Hard Gelatin Capsules.
Oral dry powder for suspension
Small Volume Parenteral (Powders)
NoneDenis William Mwesigwa10/1/2023
441196/GMP/2020 CCYeluri Formulations Pvt. LimitedSy. No. 296/7/6, IDA Bollaram, Sangareddy District - 502325, Telengana - IndiaIndia6/11/2020RT12764310/1/202010/1/2023Beta Lactam (Penicillins), Beta Lactam (Cephalosporin)Beta Lactam (Penicillins): Hard gelatin capsules
Coated and uncoated tablets
Oral dry powder for suspension
, Beta Lactam (Cephalosporin): Small Volume Parenterals (Powders)
Beta Lactam (Penicillins): Hard gelatin capsules
Coated and uncoated tablets
Oral dry powder for suspension
, Beta Lactam (Cephalosporin): Small Volume Parenterals (Powders)
NoneDenis William Mwesigwa10/1/2023
442197/GMP/2020 CCGeno Pharmaceuticals Private LimitedTivim Industrial Estate, Karaswada, Mapusa, Goa – 403526 - IndiaIndia6/17/2020FU19/59510/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Hard gelatin Capsules
Creams
Gels
Ointments
Oral liquids
Tablets
Non-Beta Lactam: Hard gelatin Capsules
Creams
Gels
Ointments
Oral liquids
Tablets
NoneDenis William Mwesigwa10/1/2023
443198/GMP/2020 CCYichang Humanwell Pharmaceutical Company LimitedNo. 19, Dalian Road, Yichang Developing Zone, Yichang, Hubei - ChinaChina6/18/2020RT12780310/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: SVP Solutions & LyophilizatesNon-Beta Lactam: SVP Solutions & LyophilizatesNoneDenis William Mwesigwa10/1/2023
444199/GMP/2020 CCHetero Labs Limited, Unit-IVillage Kalyanpur, Chakkan Road, Baddi, Dist. Solan, Himachal Pradesh, Pin code: 173205 - IndiaIndia1/14/2020FU19/36310/1/202010/1/2023CephalosporinCephalosporin: Tablets
Powders for oral suspension
Cephalosporin: Tablets
Powders for oral suspension
NoneDenis William Mwesigwa10/1/2023
445200/GMP/2020 CCGlenmark Pharmaceuticals Limited, Unit-IIIVillage - Kishanpura, Baddi Nalagarh Road, Tehsil - Baddi, Distt. Solan, H.P., 173205India3/4/2020RT12452910/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Dry powder inhalers (Capsules)
Nasal sprays
Metered dose inhalers
Non-Beta Lactam: Dry powder inhalers (Capsules)
Nasal sprays
Metered dose inhalers
NoneDenis William Mwesigwa10/1/2023
446201/GMP/2020 CCCiron Drugs and Pharmaceuticals Pvt. LimitedN-118, 118/1, 119, 119/1, 119/2, 113, MIDC, Tarapur, Boisar, Dist. Thane 401506, Maharashtra State - IndiaIndia7/7/2020RT127799, RT127800, RT12936110/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: SVP Solutions in Ampoules & Vials)
SVP (Lyophilized) powders
SVP Power for Injections
Eye/Ear/Nasal drops
Oral liquids
Externals (Creams, Ointment, Gels)
Non-Beta Lactam: SVP Solutions in Ampoules & Vials)
SVP (Lyophilized) powders
SVP Power for Injections
Eye/Ear/Nasal drops
Oral liquids
Externals (Creams, Ointment, Gels)
NoneDenis William Mwesigwa10/1/2023
447202/GMP/2020 CCShanghai Dahua Pharmaceutical Company Limited3503 Changzheng Road, Changzheng Farm, Chongming County, Shanghai 202174 - ChinaChina6/30/2020RT12836010/1/202010/1/2023HormonesHormones: Levonorgesterol Hormonal ImplantsHormones: Levonorgesterol Hormonal ImplantsNoneDenis William Mwesigwa10/1/2023
448203/GMP/2020 CCAmanta Healthcare LimitedPlot No. 876, N.H. No. 8, Village - Hariyala, Dist - Kheda 387411, Gujarat - IndiaIndia7/2/2020RT129000, RT12928210/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: SVP Solutions
LVP Solutions
Eye/Ear/Nasal drops
Non-Beta Lactam: SVP Solutions
LVP Solutions
Eye/Ear/Nasal drops
NoneDenis William Mwesigwa10/1/2023
449204/GMP/2020 CCElys Chemical Industries Limited (Unit 1)No. 6, Road B, Off Enterprise Road, Opposite Hillock Inn, Industrial Area, P.O. Box 40411, G.P.O. 00100, Nairobi - KenyaKenya7/3/2020RT129048, RT129049, RT12929610/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Tablets, coated and uncoated
Oral liquids
Oral Rehydration Salts
Hard gelatin capsules
Topical semi-solid preparations (creams & ointments)
Non-Beta Lactam: Tablets, coated and uncoated
Oral liquids
Oral Rehydration Salts
Hard gelatin capsules
Topical semi-solid preparations (creams & ointments)
NoneDenis William Mwesigwa10/1/2023
450205/GMP/2020 CCBilim Ilac San. Ve. Tic. A.SCerkezkoy Organize Sanayi Bolgesi, Karaagac, Mh. 5. Sk. No. 6, Kapakli - Tekirdag 59510 - TurkeyTurkey7/6/2020RT129318, RT12986010/1/202010/1/2023Beta Lactam (Penicillin)Beta Lactam (Penicillin): Coated and Uncoated Tablets
Oral Powders for Suspension
Beta Lactam (Penicillin): Coated and Uncoated Tablets
Oral Powders for Suspension
NoneDenis William Mwesigwa10/1/2023
451206/GMP/2020 CCIntas Pharmaceutical LimitedIntas Pharmaceutical Limited Camp Road Selaqui 248197 Dehradun (Uttarakhand) - IndiaIndia7/23/2020RT12980810/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Tablets (Coated & Uncoated)
Hard gelatin capsules
Non-Beta Lactam: Tablets (Coated & Uncoated)
Hard gelatin capsules
NoneDenis William Mwesigwa10/1/2023
452207/GMP/2020 CCHetero Labs Limited, Unit III - GeneralVillage Kalyanpur, Chakkan Road, Baddi, Dist. Solan, Himachal Pradesh, Pin code: 173205 - IndiaIndia6/18/2020FU19/59710/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
NoneDenis William Mwesigwa10/1/2023
453208/GMP/2020 CCAristo Pharmaceuticals Private LimitedPlot No. 208, New Industrial Area No. II, Mandideep 462046, Dist - Raisen, Madhya Pradesh - IndiaIndia7/16/2020RT12955510/1/202010/1/2023Non-Beta Lactam, Cephalosporin, PenicillinNon-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Oral powders (sachets)
Oral liquids
Creams/Ointments/Lotions, Small Volume Parenteral Liquids. Cephalosporin: Small Volume Parenteral Powders. Penicillin: Small Volume Parenteral Powders
Non-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Oral powders (sachets)
Oral liquids
Creams/Ointments/Lotions, Small Volume Parenteral Liquids. Cephalosporin: Small Volume Parenteral Powders. Penicillin: Small Volume Parenteral Powders
NoneDenis William Mwesigwa10/1/2023
454209/GMP/2020 CCMedisel Kenya LimitedPlot no. LR. NO. 4953/1209, General Kago road, P.O. Box 540 - 01000, Thika - KenyaKenya7/14/2020RT12946510/1/202010/1/2023Non-Beta Lactam (Vet)Non-Beta Lactam (Vet): Tablets (boluses)
Oral liquids
Oral powder in sachets
Non-Beta Lactam (Vet): Tablets (boluses)
Oral liquids
Oral powder in sachets
NoneDenis William Mwesigwa10/1/2023
455210/GMP/2020 CCLiptis for Pharmaceuticals and Medical ProductsPlot No. B/2, 6th Industrial zone, 6th of October city-EgyptEgypt7/16/2020RT129536, RT12953510/1/202010/1/2023Non-Beta LactamNon-Beta Lactam: Coated and Uncoated Tablets
Hard Gelatin Capsules
Non-Beta Lactam: Coated and Uncoated Tablets
Hard Gelatin Capsules
NoneDenis William Mwesigwa10/1/2023
456212/GMP/2020 CCHebei Hope Harmony Pharmaceutical Company LimitedIndustry Development Area, Yuanshi County, Shijiazhuang City, Hebei Province - People's Republic of ChinaChina8/6/2020RT13021910/8/202010/8/2023Non-Beta LactamNon-Beta Lactam: Tablets
Oral liquids
Small Volume Parenteral solutions (Ampoules & vials)
Oral soluble powders in sachets
Non-Beta Lactam: Tablets
Oral liquids
Small Volume Parenteral solutions (Ampoules & vials)
Oral soluble powders in sachets
NoneDenis William Mwesigwa10/8/2023
457213/GMP/2020 CCChiros PharmaVillage Loharon, P.O. Ghatti, Distt. - Solan, Himachal Pradesh - IndiaIndia8/5/2020RT13019010/8/202010/8/2023Penicillin
(Beta-lactam)
Penicillin
(Beta-lactam): Tablets (Coated and Uncoated)
Hard gelatin capsules
Dry syrups
Penicillin
(Beta-lactam): Tablets (Coated and Uncoated)
Hard gelatin capsules
Dry syrups
NoneDenis William Mwesigwa10/8/2023
458214/GMP/2020 CCMankind Pharma LimitedUnit - II, Village Kishanpura, P.O. Jamniwala, Tehsil Paonta Sahib, District Sirmour - 173025, Himachal Pradesh - IndiaIndia8/12/2020RT130421, FU20/07710/8/202010/8/2023Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Soft Gelatin Capsules
Oral liquid
Dry powder for oral suspension
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
Soft Gelatin Capsules
Oral liquid
Dry powder for oral suspension
NoneDenis William Mwesigwa10/8/2023
459214/GMP/2020 CCMankind Pharma LimitedUnit – I, Village Kishanpura, P.O Jamniwala, Tehsil Paonta Sahib, District Sirmour - 173025 Himachal Pradesh - IndiaIndia8/12/2020RT13042010/8/202010/8/2023Non-Beta Lactam, Beta Lactam
(Cephalosporin)
Non-Beta Lactam: Small Volume Parenterals liquids in ampoules, Beta Lactam
(Cephalosporin): Small volume Powder for Injections in vials
Non-Beta Lactam: Small Volume Parenterals liquids in ampoules, Beta Lactam
(Cephalosporin): Small volume Powder for Injections in vials
NoneDenis William Mwesigwa10/8/2023
460215/GMP/2020 CCBeximco Pharmaceuticals Limited126 Kathaldia, Auchpara, Tongi - 1711, Gazipur BangladeshBangladesh8/17/2020FU20/09210/12/202010/12/2023Non-Beta LactamNon-Beta Lactam: Tablets (Coated & uncoated)
Hard Gelatin Capsules
Eye Drops (in three-piece plastic bottle)
Pressurized metered dose inhaler preparations
Non-Beta Lactam: Tablets (Coated & uncoated)
Hard Gelatin Capsules
Eye Drops (in three-piece plastic bottle)
Pressurized metered dose inhaler preparations
NoneDenis William Mwesigwa10/12/2023
461216/GMP/2020 CCMSN Laboratories Private Limited - Formulations DivisionPlot No. 42, Anrich Industrial Estate, Bollaram, Sanagareddy District – 502325, Telengana, IndiaIndia8/19/2020RT13071110/12/202010/12/2023Non-Beta LactamNon-Beta Lactam: Tablets (coated and uncoated)
Hard gelatin capsules
Small volume parenteral solutions in Ampoule and vials
Small volume parenteral lyophilized powders in vials
Non-Beta Lactam: Tablets (coated and uncoated)
Hard gelatin capsules
Small volume parenteral solutions in Ampoule and vials
Small volume parenteral lyophilized powders in vials
NoneDenis William Mwesigwa10/12/2023
462217/GMP/2020 CCNovartis Saglik, Gida ve Tarim Urunleri San. Ve Tic. A.S.Yenisehir Mahallesi Ihlara Vadisi Sokak No. 2 Pendik Istanbul TR 34912 - TurkeyTurkey8/20/2020FU20/103, FU20/13010/12/202010/12/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa10/12/2023
463218/GMP/2020 CCBliss GVS Pharma LimitedPlot No. 11, Survey No. 38/1, Dewan Udyog Nagar, Aliyali, Palghar, Maharashtra 401404 - IndiaIndia8/25/2020RT13092010/12/202010/12/2023Non-Beta LactamNon-Beta Lactam: SuppositoriesNon-Beta Lactam: SuppositoriesNoneDenis William Mwesigwa10/12/2023
464219/GMP/2020 CCBliss GVS Pharma LimitedPlot 10, 11 & 12 Dewan Udyong Nagar, Aliyali, Palphar, Dist. Thane 401404, Maharashtra – IndiaIndia8/25/2020RT13091910/12/202010/12/2023Non-Beta LactamNon-Beta Lactam: Tablets (Coated and Uncoated)
Dry powder for oral suspension
Suppositories
Non-Beta Lactam: Tablets (Coated and Uncoated)
Dry powder for oral suspension
Suppositories
NoneDenis William Mwesigwa10/12/2023
465220/GMP/2020 CCWilshire Laboratories Private Limited124/1 Industrial Area Kot Lakhpat Lahore - PakistanPakistan9/11/2020RT129566, RT131590, RT13158910/12/202010/12/2023Non-Beta LactamNon-Beta Lactam: Coated and uncoated Tablets
Hard gelatin capsules
Powders for oral suspension
Small and Large volume parenteral liquids
Small volume powder for injection
Non-Beta Lactam: Coated and uncoated Tablets
Hard gelatin capsules
Powders for oral suspension
Small and Large volume parenteral liquids
Small volume powder for injection
NoneDenis William Mwesigwa10/12/2023
466221/GMP/2020 CCCachet Pharmaceutical Private LimitedVillage-Thana, Baddi, Tehsil Nalagarh, Dist. Solan, Himachal Pradesh-173205 - IndiaIndia9/1/2020RT131226, RT13122710/12/202010/12/2023Non-Beta LactamNon-Beta Lactam: Oral Liquids for internal use
Tablets
Hard gelatin Capsules
Oral powders in Sachets
Non-Beta Lactam: Oral Liquids for internal use
Tablets
Hard gelatin Capsules
Oral powders in Sachets
NoneDenis William Mwesigwa10/12/2023
467222/GMP/2020 CCIntracin Pharmaceuticals Private LimitedC-1 B-53, G.I.D.C. Estate, Nadiad - 387 001 (Gujarat) IndiaIndia9/3/2020RT13132610/12/202010/12/2023Non-Beta Lactam, Beta-Lactam (Cephalosporin)Non-Beta Lactam: Small volume parenteral liquids ,Beta-Lactam (Cephalosporin): Small volume powder for InjectionNon-Beta Lactam: Small volume parenteral liquids ,Beta-Lactam (Cephalosporin): Small volume powder for InjectionNoneDenis William Mwesigwa10/12/2023
468223/GMP/2020 CCGlobela Pharma Pvt. Limited357, 358, Road No. 3, Sachin G.I.D.C., Sachin, Surat 394230, Gujarat - IndiaIndia9/4/2020RT131372, FU20/13710/12/202010/12/2023Non-Beta Lactam, OncologyNon-Beta Lactam: Tablets (coated and uncoated)
Hard gelatin capsules
Oral powder in Sachets and bottles.
, Oncology: Tablets
Hard gelatin capsules
Non-Beta Lactam: Tablets (coated and uncoated)
Hard gelatin capsules
Oral powder in Sachets and bottles.
, Oncology: Tablets
Hard gelatin capsules
NoneDenis William Mwesigwa10/12/2023
469224/GMP/2020 CCCipla Limited Unit VII PD IIPlot No. L 139. S-103 & M-62. Verna Industrial Estate. Verna, Salcette. Goa - 403722 - IndiaIndia9/7/2020RT131429, RT13143010/12/202010/12/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa10/12/2023
470225/GMP/2020 CCPacific Pharmaceuticals Limited30th Kilometre, Multan Road, Lahore - PakistanPakistan4/2/2019RT10846910/12/202010/12/2023Non-Beta LactamNon-Beta Lactam: Tablets
Hard gelatin Capsules
Oral liquids
Creams and ointments
Non-Beta Lactam: Tablets
Hard gelatin Capsules
Oral liquids
Creams and ointments
NoneDenis William Mwesigwa10/12/2023
471226/GMP/2020 CCAristo Pharmaceuticals Pvt. LimitedVillage: Makhnumajra, P.O. Bhud, Baddi, District-Solan, Himachal Pradesh, 173205 - IndiaIndia9/15/2020RT13166610/12/202010/12/2023Non-Beta Lactam, Beta Lactam (Cephalosporin)Non-Beta Lactam: Tablets (coated and uncoated)
Hard Gelatin capsules
, Beta Lactam (Cephalosporin): Tablets (coated and uncoated)
Oral dry powder for suspension
Small Volume Parenteral (powders)
Non-Beta Lactam: Tablets (coated and uncoated)
Hard Gelatin capsules
, Beta Lactam (Cephalosporin): Tablets (coated and uncoated)
Oral dry powder for suspension
Small Volume Parenteral (powders)
NoneDenis William Mwesigwa10/12/2023
472227/GMP/2020 CCThe Searle Company Limited32-km Multan Road, Lahore - PakistanPakistan9/25/2020RT13239010/12/202010/12/2023Non-Beta LactamNon-Beta Lactam: Tablets (Coated and Uncoated)
Hard gelatin capsules
Oral Liquids for internal use
Non-Beta Lactam: Tablets (Coated and Uncoated)
Hard gelatin capsules
Oral Liquids for internal use
NoneDenis William Mwesigwa10/12/2023
473303/GMP/2020 CCBASF SECarl-Bosch-Strasse 38, 67056 Ludwigshafen - GermanyGermany2/7/2017RT79400/RT2465310/13/202010/13/2023Food supplementsFood supplements: 1.7 Mio iu/Kg BHT Stab
Vitamin A Palmitate 1.7 Mio iu/Kg Toc Stab
Food supplements: 1.7 Mio iu/Kg BHT Stab
Vitamin A Palmitate 1.7 Mio iu/Kg Toc Stab
NoneDenis William Mwesigwa10/13/2023
474304/GMP/2020 CCCross Vetpharm Group LimitedBroomhill Road, Tallaght, 24 Dublin - IrelandIreland5/15/2017RT8262310/13/202010/13/2023Beta Lactam
(Penicillin), Non-Beta Lactam, Non-Beta Lactam
Acaricides
Beta Lactam
(Penicillin): Sterile Intramammary products in prefilled syringes, Non-Beta Lactam: Sterile Intramammary products in prefilled syringes, Non-Beta Lactam (Acaricides): Oral Liquids (Drenches)
Ectoparasiticides
Beta Lactam
(Penicillin): Sterile Intramammary products in prefilled syringes, Non-Beta Lactam: Sterile Intramammary products in prefilled syringes, Non-Beta Lactam (Acaricides): Oral Liquids (Drenches)
Ectoparasiticides
NoneDenis William Mwesigwa10/13/2023
475307/GMP/2020 DRAlcami Carolinas Corporation1726 North 23rd Street Wilmington, North Carolina 28405 United States of AmericaUnited States Of America104941812/9/2019RT12003910/13/202010/13/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa10/13/2023
476308/GMP/2020 DRArtesan Pharma GmbH & Company KGWendlandstr. 1, 29439 Luchow - GermanyGermanyDE_NI_03_MIA_2018_00087/10/2020RT12941610/13/202010/13/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa10/13/2023
477309/GMP/2020 DRExcella GmbH & Company KGNuernberger Strasse 12, 90537 Feucht - GermanyGermanyDE_BY_05_MIA_2018_003810/29/2018RT10269010/13/202010/13/2023CytotoxicCytotoxic: TabletsCytotoxic: TabletsNoneDenis William Mwesigwa10/13/2023
478230/GMP/2020 CCCSPC Zhongnuo Pharmaceuticals (Shijiazhuang) Company Limited)No. 88 Yangzi Road, Shijiazhuang City, Hebei Province, (Workshop 402) - ChinaChina3/18/2019RT10807110/16/202010/16/2023CephalosporinCephalosporin: Powders for injectionCephalosporin: Powders for injectionNoneDenis William Mwesigwa10/16/2023
479231/GMP/2020 CCMapharKm 10 Coastal Road 111, Industrial District, Zenata, Ain Sebaa – Casablanca – Morocco, RC Casablanca no 16985 - MoroccoMorocco5/31/2019RT11133010/16/202010/16/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa10/16/2023
480232/GMP/2020 CCAl-Fazal Pharma Industries Private LimitedPlot 20, 21, 22 Defence Industrial Zone - Moman Pura, 16km Sheikhupura Road, (Lahore) - PakistanPakistan9/11/2020RT131591, RT13159210/16/202010/16/2023Non-Beta LactamNon-Beta Lactam: Oral Liquids
Hard Gelatin Capsules
Ointments/Creams/Gels
Non-Beta Lactam: Oral Liquids
Hard Gelatin Capsules
Ointments/Creams/Gels
NoneDenis William Mwesigwa10/16/2023
481234/GMP/2020 CCNingbo Dahongying Pharmaceutical Company LimitedNo. 396 Ming Zhu Road, High Tech Park, Ningbo City. ChinaChina6/19/2019RT11195110/16/202010/16/2023Non-Beta LactamNon-Beta Lactam: Tablets
Capsules
SVP liquids
Non-Beta Lactam: Tablets
Capsules
SVP liquids
NoneDenis William Mwesigwa10/16/2023
482235/GMP/2020 CCPharma Swede Egypt10th of Ramadan City – Industrial Zone B3 - EgyptEgypt10/6/2020RT13283410/19/202010/19/2023Non-Beta Lactam (Veterinary)Non-Beta Lactam (Veterinary): Boluses (Tablets)
Oral liquids- Solutions, Suspensions & Emulsions
Oral Powders and Premixes
Small Volume Parenterals
Large Volume Parenterals
Non-Beta Lactam (Veterinary): Boluses (Tablets)
Oral liquids- Solutions, Suspensions & Emulsions
Oral Powders and Premixes
Small Volume Parenterals
Large Volume Parenterals
NoneDenis William Mwesigwa10/19/2023
483236/GMP/2020 DRDelpharm Huningue S.A.S26, rue de la Chapelle, 68330 Huningue, FranceFrance10/8/2020FU20/20710/19/202010/19/2023Non-Beta LactamNon-Beta Lactam: Suppositories
Liquids for external use
Liquids for internal use
Semi solids
Non-Beta Lactam: Suppositories
Liquids for external use
Liquids for internal use
Semi solids
NoneDenis William Mwesigwa10/19/2023
484237/GMP/2020 CCThe Madras PharmaceuticalsNo. 137B, Old Mahabalipuram, Karapakkam, Chennai 600096, Tamil Nadu State - IndiaIndia8/12/2020RT13044810/19/202010/19/2023Non-Beta LactamNon-Beta Lactam: Tablets (coated and uncoated)
Hard Gelatin Capsules
Dry Syrups for suspension
Oral Liquids
Ointments, gels and Creams
Non-Beta Lactam: Tablets (coated and uncoated)
Hard Gelatin Capsules
Dry Syrups for suspension
Oral Liquids
Ointments, gels and Creams
NoneDenis William Mwesigwa10/19/2023
485238/GMP/2020 CCBF Biosciences Limited (A Subsidiary of Ferozsons Laboratories Limited).5km, Sunder Raiwind Road, Raiwind Lahore - PakistanPakistan10/5/2020RT132728, RT13273110/19/202010/19/2023Non-Beta LactamNon-Beta Lactam: SVP Solutions & LyophilizatesNon-Beta Lactam: SVP Solutions & LyophilizatesNoneDenis William Mwesigwa10/19/2023
486239/GMP/2020 CCLeben Laboratories Private LimitedPlot No. L-4 & L-15, Phase-III, MIDC, Akola-444 104 (MS) - IndiaIndia10/12/2020RT13295610/19/202010/19/2023Non-Beta Lactam, Beta-lactam (Penicillin & Cephalosporin)Non-Beta Lactam: Tablets
Hard gelatin capsules
Oral Liquids
External Preparations (Ointments, Creams, Lotions)
, Beta-lactam (Penicillin & Cephalosporin): Tablets
Hard gelatin capsules
Dry powder for suspension
Non-Beta Lactam: Tablets
Hard gelatin capsules
Oral Liquids
External Preparations (Ointments, Creams, Lotions)
, Beta-lactam (Penicillin & Cephalosporin): Tablets
Hard gelatin capsules
Dry powder for suspension
NoneDenis William Mwesigwa10/19/2023
487241/GMP/2020 CCEgis Pharmaceuticals PLCBokenyfoldi UT 118-120, Budapest, 1165, HungaryHungary10/12/2020RT13294610/19/202010/19/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa10/19/2023
488242/GMP/2020 CCArtura Pharmaceuticals Pvt. LtdNo. 1505, Portia Road Sri City SEZ, Satyavedu Mandal, Chittoor Dist-517 588, Andhra Pradesh, IndiaIndia10/13/2020RT133042, RT13304310/19/202010/19/2023Non-Beta LactamNon-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Non-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
NoneDenis William Mwesigwa10/19/2023
489243/GMP/2020 CCCadila Healthcare LimitedPlot No. 417, 419 & 420, Sarkhej-Bavla N.H. No. 8A, Moraiya, Tal: Sanand, Dist. Ahmedabad - 382210, Gujarat, IndiaIndia7/17/2020RT129575, RT12958210/19/202010/19/2023Non-Beta LactamNon-Beta Lactam: Tablets (Coated & Uncoated)
Soft & Hard Gelatin Capsules
Metered Dose Inhalers and Nasal Sprays
Lyophilized anti-rabies vaccine
Non-Beta Lactam: Tablets (Coated & Uncoated)
Soft & Hard Gelatin Capsules
Metered Dose Inhalers and Nasal Sprays
Lyophilized anti-rabies vaccine
NoneDenis William Mwesigwa10/19/2023
490244/GMP/2020 CCLG Life Sciences LimitedYongje-dong Iksa-51, Jeonbuk-Do 570350-South KoreaSouth Korea2/12/2016RT6880510/19/202010/19/2023BiologicalsBiologicals: Small Volume Liquids (Aseptically prepared)Biologicals: Small Volume Liquids (Aseptically prepared)NoneDenis William Mwesigwa10/19/2023
491245/GMP/2020 CCBrookes Pharma Private Limited58, 59 Sector 15, Korangi Industrial Area, Karachi PakistanPakistan7/3/2020RT129289, RT12929010/19/202010/19/2023Non-Beta LactamNon-Beta Lactam: Small Volume Liquids (Aseptically Prepared & Terminally Sterilized)
Liquids for external use
Liquids for Internal use
Semi – Solids (creams, ointments and gels)
Tablets
Non-Beta Lactam: Small Volume Liquids (Aseptically Prepared & Terminally Sterilized)
Liquids for external use
Liquids for Internal use
Semi – Solids (creams, ointments and gels)
Tablets
NoneDenis William Mwesigwa10/19/2023
492246/GMP/2020 DRTakeda GmbHPlant Oranienburg, Lehnitzstrasse 70-98, DE – 16515, GermanyGermanyDE_BB_01_MIA_2019_00098/18/2020RT13062810/21/202010/21/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa10/21/2023
493247/GMP/2020 DRPanpharma GmbH (formerly Rotexmedica GmbH Arzneimittelwerk)Bunsenstrasse 4, 22946 Trittau - GermanyGermanyDE_SH_01_MIA_2019_00304/8/2020RT12561810/21/202010/21/2023Non-Beta LactamNon-Beta Lactam: Small Voume Liquids (Aseptically prepared)
Large Volume Liquids (Terminally sterilized)
Non-Beta Lactam: Small Voume Liquids (Aseptically prepared)
Large Volume Liquids (Terminally sterilized)
NoneDenis William Mwesigwa10/21/2023
494250/GMP/2020 CCIndus Pharma Private LimitedPlot No. 65, Sector 27 Korangi Industrial Area, Karachi – 74900 - PakistanPakistan5/15/2020RT12649310/22/202010/22/2023Non-Beta Lactam, Beta LactamNon-Beta Lactam: Small Volume Parenteral liquids
Tablets
Powder in sachets for oral Suspension
Oral Liquids
, Beta Lactam: Hard Gelatin Capsules
Oral Liquids
Non-Beta Lactam: Small Volume Parenteral liquids
Tablets
Powder in sachets for oral Suspension
Oral Liquids
, Beta Lactam: Hard Gelatin Capsules
Oral Liquids
NoneDenis William Mwesigwa10/22/2023
495251/GMP/2020 CCAbbott Laboratories (Pakistan) LimitedOpp. Radio Pakistan Transmission Centre Hyderabad Road, Landhi, Karachi - 75120Pakistan7/3/2019RT11224910/28/202010/28/2023Non-Beta LactamNon-Beta Lactam: Tablets
Liquids for Internal use
Ointments, Creams & Gels
Non-Beta Lactam: Tablets
Liquids for Internal use
Ointments, Creams & Gels
NoneDenis William Mwesigwa10/28/2023
496252/GMP/2020 CCReyoung Pharmaceutical Co. LimitedNo. 1 Ruiyang Road Yiyuan County, Shandong Province, People’s Republic of ChinaChina5/23/2019RT11110110/28/202010/28/2023Non-Beta Lactam, Beta Lactam (Penicillin)Non-Beta Lactam: SVP Powders
SVP Solutions
Tablets
, Beta Lactam (Penicillin): Hard gelatin Capsules
Small Volume Parenteral Powders
Non-Beta Lactam: SVP Powders
SVP Solutions
Tablets
, Beta Lactam (Penicillin): Hard gelatin Capsules
Small Volume Parenteral Powders
NoneDenis William Mwesigwa10/28/2023
497253/GMP/2020 CCEgyptian International Pharmaceuticals Industries Company (EIPICO)10th of Ramadan city, Industrial Area BI-Egypt, P.O. Box 149 -10th - EgyptEgypt11/8/2019RT118870, RT11886910/28/202010/28/2023Non-Beta Lactam, Beta Lactam
(Cephalosporins), Beta Lactam (Penicillin)
Non-Beta Lactam: Tablets (Coated and Uncoated)
Hard Gelatin Capsules
Soft Gelatin Capsules
Creams, Ointments and Suppositories
Oral Liquids
Eye Ointments
Eye sterile Drops
Oral powder for suspension
Small Volume Parenterals-Powders-Lyophilized
Small Volume Parenterals-Solutions-Hormones
, Beta Lactam
(Cephalosporins): Small Volume Parenterals-Powders, Beta Lactam (Penicillin): Tablets (Coated &uncoated)
Hard Gelatin Capsules
Oral powder for suspension
Non-Beta Lactam: Tablets (Coated and Uncoated)
Hard Gelatin Capsules
Soft Gelatin Capsules
Creams, Ointments and Suppositories
Oral Liquids
Eye Ointments
Eye sterile Drops
Oral powder for suspension
Small Volume Parenterals-Powders-Lyophilized
Small Volume Parenterals-Solutions-Hormones
, Beta Lactam
(Cephalosporins): Small Volume Parenterals-Powders, Beta Lactam (Penicillin): Tablets (Coated &uncoated)
Hard Gelatin Capsules
Oral powder for suspension
NoneDenis William Mwesigwa10/28/2023
498254/GMP/2020 CCUnichem Laboratories Limited (Unit-I)Village Bhatauli Kalan, The Baddi, Distt. Solan, Himachal Pradesh, 173205 – IndiaIndia10/18/2019RT11806910/28/202010/28/2023Beta Lactam
(Penicillin)
Beta Lactam
(Penicillin): Tablets
Hard Gelatin Capsules
Dry powder for suspension
Sterile powder for injection(SVP)
Beta Lactam
(Penicillin): Tablets
Hard Gelatin Capsules
Dry powder for suspension
Sterile powder for injection(SVP)
NoneDenis William Mwesigwa10/28/2023
499255/GMP/2020 CCFerozsons Laboratories LimitedAmangarh Nowshera (Khyber,Pakhtunkhwa) - PakistanPakistan10/5/2020RT132729, RT13273010/28/202010/28/2023Non-Beta LactamNon-Beta Lactam: Tablets (Coated and Uncoated)
Semi-solids (Ointments and Creams)
Hard gelatin capsules (filling and packaging)
Dry powders for oral suspension
Non-Beta Lactam: Tablets (Coated and Uncoated)
Semi-solids (Ointments and Creams)
Hard gelatin capsules (filling and packaging)
Dry powders for oral suspension
NoneDenis William Mwesigwa10/28/2023
500240/GMP/2020 CCAdcock Ingram LimitedNo. 49 C and D Bommasandra Industrial Area Anekal Taluk Bangalore - IndiaIndia10/16/2020RT133212, RT13321310/29/202010/29/2023Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
NoneDenis William Mwesigwa10/29/2023
501256/GMP/2020 CCCentaur Pharmaceuticals Private LimitedPlant II: Plot No. 39-41, Tivim Industrial Estate, Karaswada, Mapusa, Goa - 403 526 - IndiaIndia10/19/2020RT13324910/29/202010/29/2023Non-Beta LactamNon-Beta Lactam: Non sterile Creams & Ointments
Sterile Ophthalmic Ointments
Non-Beta Lactam: Non sterile Creams & Ointments
Sterile Ophthalmic Ointments
NoneDenis William Mwesigwa10/29/2023
502257/GMP/2020 CCNational Healthcare Private LimitedNational Healthcare Private Limited, Chhatapipra, Bara -NepalNepal10/13/2020RT13300110/29/202010/29/2023Non-Beta Lactam, Beta Lactam (Penicillin), Beta Lactam (Cephalosporin)Non-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Small Volume Parenteral Liquids (Vials & Ampoules)
Eye/Ear Drops
Lyophilized powders for injection
, Beta Lactam (Penicillin): Tablets (Coated & Uncoated)
Hard gelatin Capsules
Small Volume Parenteral Powders
, Beta Lactam (Cephalosporin): Small Volume Parenteral Powders
Non-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Small Volume Parenteral Liquids (Vials & Ampoules)
Eye/Ear Drops
Lyophilized powders for injection
, Beta Lactam (Penicillin): Tablets (Coated & Uncoated)
Hard gelatin Capsules
Small Volume Parenteral Powders
, Beta Lactam (Cephalosporin): Small Volume Parenteral Powders
NoneDenis William Mwesigwa10/29/2023
503258/GMP/2020 DRGrunenthal GmbHZieglerstr. 6, 52078 Aachen - GermanyGermany12/16/2019RT12028910/29/202010/29/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa10/29/2023
504259/GMP/2020 DRFarmaceutici Formenti S.p.AVia di Vittorio, 2 - 21040 Origgio (VA) - ItalyItalyaM113//201912/16/2019RT12028810/29/202010/29/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa10/29/2023
505260/GMP/2020 DRCombino Pharm (Malta) LimitedHF60 Hal Far Industrial Estate BBG3000 - MaltaMaltaML0082/11/2020FU19/428 RT12330710/29/202010/29/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa10/29/2023
506261/GMP/2020 CCTorrent Pharmaceuticals LimitedIndrad - 382721, Tal: Kadi, City - Indrad, Dist. Mehsana, Gujarat State - IndiaIndia10/22/2020RT133406, RT13340710/29/202010/29/2023Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
NoneDenis William Mwesigwa10/29/2023
507262/GMP/2020 DRMedochemie Limited (Factory AZ).2 Michael Erakleous Street, Agios Athanassios Industrial Area, Agios Athanassios, Limassol, 4101 - CyprusCyprus10/22/2020RT13341010/29/202010/29/2023Non-Beta LactamNon-Beta Lactam: Hard Gelatin Capsules
Tablets (Coated and Uncoated)
Non-Beta Lactam: Hard Gelatin Capsules
Tablets (Coated and Uncoated)
NoneDenis William Mwesigwa10/29/2023
508263/GMP/2020 DRMedochemie Limited (Factory B - Oral Facility).Plot 48, Lapetou Street, Agios Athanassios Industrial Area, 41101 Agios Athanassios, Limassol - CyprusCyprus10/22/2020RT13340910/29/202010/29/2023Beta Lactam (Penicillin)Beta Lactam (Penicillin): Powders for oral suspension
Tablets
Hard Gelatin Capsule
Small Volume Liquids (Sterile API Powder – Aseptically filled)
Beta Lactam (Penicillin): Powders for oral suspension
Tablets
Hard Gelatin Capsule
Small Volume Liquids (Sterile API Powder – Aseptically filled)
NoneDenis William Mwesigwa10/29/2023
509264/GMP/2020 DRMedochemie Limited (Factory C).2 Michael Erakleous Street, Agios Athanassios Industrial Area, 4101 Agios Athanassios, Limassol - Cyprus.Cyprus10/22/2020RT13341110/29/202010/29/2023Beta Lactam (Cephalosporin)Beta Lactam (Cephalosporin): Powders for Oral suspension
Tablets (Coated and uncoated)
Hard Gelatin Capsules
Small Volume Liquids (Sterile API powder-Aseptically filled)
Beta Lactam (Cephalosporin): Powders for Oral suspension
Tablets (Coated and uncoated)
Hard Gelatin Capsules
Small Volume Liquids (Sterile API powder-Aseptically filled)
NoneDenis William Mwesigwa10/29/2023
510265/GMP/2020 CCATCO Laboratories LimitedB-18, S.I.T.E, Karachi, 74700 - PakistanPakistan10/26/2020RT13349010/29/202010/29/2023Non-Beta LactamNon-Beta Lactam: Semi-solids (Ointments and Creams)
Oral Liquids
Eye drops (Sterile)
Tablets (Coated & Uncoated)
Sterile enema (Lotion)
Non-Beta Lactam: Semi-solids (Ointments and Creams)
Oral Liquids
Eye drops (Sterile)
Tablets (Coated & Uncoated)
Sterile enema (Lotion)
NoneDenis William Mwesigwa10/29/2023
511266/GMP/2020 CCGlobal Napi Pharmaceuticals2nd Industrial Zone, St. 18, No. 40, 6th October City - EgyptEgypt10/26/2020RT13348810/29/202010/29/2023Non-Beta LactamNon-Beta Lactam: Tablets (Coated and Uncoated)
Hard Gelatin Capsules
Creams, Ointments and Suppositories
Non-Beta Lactam: Tablets (Coated and Uncoated)
Hard Gelatin Capsules
Creams, Ointments and Suppositories
NoneDenis William Mwesigwa10/29/2023
512267/GMP/2020 DRSophartex Laboratories21 Rue du Pressoir, 28500, Vernouillet - FranceFrance10/27/2020FU20/24510/29/202010/29/2023Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Sachets
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
Sachets
NoneDenis William Mwesigwa10/29/2023
513268/GMP/2020 CCEast African (Indian) OverseasPlot No. - 1, Pharmacity, Selaqui, Dehradun - 248011 (U.K) - IndiaIndia9/9/2019RT11629310/30/202010/30/2023Non-Beta Lactam, Beta Lactam
(Cephalosporin)
Non-Beta Lactam: Tablets
Hard gelatin capsules
Small Volume Parenteral solutions in glass ampoules & vials
Small Volume Parenterals (Powders for injection)
Small Volume Parenterals (Eye Drops)
Oral liquids
External preparation (Ointment)
, Beta Lactam
(Cephalosporin): Tablets
Capsules
Small Volume Parenterals (Powders for injection)
Non-Beta Lactam: Tablets
Hard gelatin capsules
Small Volume Parenteral solutions in glass ampoules & vials
Small Volume Parenterals (Powders for injection)
Small Volume Parenterals (Eye Drops)
Oral liquids
External preparation (Ointment)
, Beta Lactam
(Cephalosporin): Tablets
Capsules
Small Volume Parenterals (Powders for injection)
NoneDenis William Mwesigwa10/30/2023
514270/GMP/2020 DRLelypharma B.VZuiveringweg 42, 8243 PZ Lelystad - NetherlandsThe Netherlands2004 - FGL11/21/2018RT10328611/2/202011/2/2023Non-Beta Lactam, Penicillin, CephalosporinNon-Beta Lactam: Tablets
Powders/Granules
, Penicillin: Tablets
Powders/Granules
, Cephalosporin: Tablets
Powders/Granules
Non-Beta Lactam: Tablets
Powders/Granules
, Penicillin: Tablets
Powders/Granules
, Cephalosporin: Tablets
Powders/Granules
NoneDenis William Mwesigwa11/2/2023
515271/GMP/2020 DRMerckle GmbHLudwig Merckle Strasse 3, 89143 Balubeuren – Weiler GermanyGermanyDE-BW-01-MIA-2017-00243/12/2020RT12494411/2/202011/2/2023Non-Beta LactamNon-Beta Lactam: Nasal Sprays (Aseptically filled)
Nasal Sprays (Terminally sterilized)
Capsules hard shell
Small Volume Liquids (Terminally Sterilized)
Non-Beta Lactam: Nasal Sprays (Aseptically filled)
Nasal Sprays (Terminally sterilized)
Capsules hard shell
Small Volume Liquids (Terminally Sterilized)
NoneDenis William Mwesigwa11/2/2023
516272/GMP/2020 DRPharmaceutical Works Polpharma SA (Zaklady Farmaceutyczne Polpharma SA)19 Pelplinska Street, 83-200 Starogard Gdanski - PolandPoland040/0105/157/7/2017RT8545811/2/202011/2/2023Non-Beta LactamNon-Beta Lactam: Large Volume Liquids (Aseptically prepared)
Tablets
Non-Beta Lactam: Large Volume Liquids (Aseptically prepared)
Tablets
NoneDenis William Mwesigwa11/2/2023
517273/GMP/2020 DRFresenius Kabi Austria GmbHAm Gewerbepark 6, Werndorf 8402 - AustriaAustria4821596/30/2020RT12835211/2/202011/2/2023Non-Beta LactamNon-Beta Lactam: Large Volume Liquids (Aseptically prepared)
Large Volume Liquids (Terminally sterilized)
Small Volume Liquids (Aseptically prepared)
Small Volume Liquids (Terminally sterlized)
Non-Beta Lactam: Large Volume Liquids (Aseptically prepared)
Large Volume Liquids (Terminally sterilized)
Small Volume Liquids (Aseptically prepared)
Small Volume Liquids (Terminally sterlized)
NoneDenis William Mwesigwa11/2/2023
518274/GMP/2020 CCGenix Pharma Pvt. Limited44, 45 – B Genix St, Sector 39 Korangi Creek, Karachi, Karachi, Karachi City, Sindh 75190 - PakistanPakistan3/2/2020RT113701, RT121183, RT12118411/2/202011/2/2023Non-Beta LactamNon-Beta Lactam: Capsules
Powders for Oral Suspension
Tablets
Non-Beta Lactam: Capsules
Powders for Oral Suspension
Tablets
NoneDenis William Mwesigwa11/2/2023
519275/GMP/2020 DRMilenia AgrocienciasRua Pedro Antonio De Souza 400, Londrina, Parawa - BrazilBrazil12/21/2016RT7792411/2/202011/2/2023AcaricidesAcaricides: Liquids for External useAcaricides: Liquids for External useNoneDenis William Mwesigwa11/2/2023
520276/GMP/2020 CCRemington Pharmaceutical Industries Private Limited18km Multan Road Lahore - PakistanPakistan5/7/2019RT11046311/2/202011/2/2023Non-Beta LactamNon-Beta Lactam: Eye Drops
Ear Drops
External Preparations (Creams & Ointments)
Eye Ointments
Oral Liquids
Non-Beta Lactam: Eye Drops
Ear Drops
External Preparations (Creams & Ointments)
Eye Ointments
Oral Liquids
NoneDenis William Mwesigwa11/2/2023
521277/GMP/2020 CCUnited Biotech Pvt. LimitedBagbania Baddi - Nalagarh Road, Dist. - Solan, H. P. 174101 - IndiaIndia10/14/2020FU19/366, RT133086, RT13308711/2/202011/2/2023OncologyOncology: Tablets
Capsules
SVP Liquid Injections in glass ampoules & vials
SVP Powder injections
SVP Lyophilized injections
Oncology: Tablets
Capsules
SVP Liquid Injections in glass ampoules & vials
SVP Powder injections
SVP Lyophilized injections
NoneDenis William Mwesigwa11/2/2023
522278/GMP/2020 CCAdwia S.A.E.1st Industrial Zone A1, 10th of Ramadan City - EgyptEgypt11/6/2020RT134043, RT13404411/12/202011/12/2023Non- Beta Lactam
(Human),
Non Beta Lactam (Veterinary)
Non- Beta Lactam
(Human): Coated and Uncoated Tablets
Oral powder for suspension
Small Volume Parenterals-Solutions in Ampoules
,
Non Beta Lactam (Veterinary): Small Volume Parenterals-Solutions in Vials
Oral powder for suspension
Non- Beta Lactam
(Human): Coated and Uncoated Tablets
Oral powder for suspension
Small Volume Parenterals-Solutions in Ampoules
,
Non Beta Lactam (Veterinary): Small Volume Parenterals-Solutions in Vials
Oral powder for suspension
NoneDenis William Mwesigwa11/12/2023
523280/GMP/2020 CCTabros Pharmaceuticals (Pvt.) LimitedL-20/B, Sector 22, FB Industial Area, Karachi - PakistanPakistan1/18/2012RT3247912/8/202012/8/2023Non- Beta LactamNon- Beta Lactam: Tablets
Hard Gelatin Capsules
Oral Liquids
Creams and Ointments
SVP Solutions
Non- Beta Lactam: Tablets
Hard Gelatin Capsules
Oral Liquids
Creams and Ointments
SVP Solutions
NoneDenis William Mwesigwa12/8/2023
524281/GMP/2020 CCMicro Labs LimitedPlot No. 121 - 124, IV Phase, K.I.A.D.B Bommasandra Industrial Area, Jigini Link Road, Anekal Taluk, Bangalore 560 099, IndiaIndia11/19/2020RT13433711/20/202011/20/2023Beta Lactam (Cephalosporin)Beta Lactam (Cephalosporin): Tablets (Coated and Uncoated)
Hard Gelatin Capsules
Dry powder for oral suspension
Beta Lactam (Cephalosporin): Tablets (Coated and Uncoated)
Hard Gelatin Capsules
Dry powder for oral suspension
NoneDenis William Mwesigwa11/20/2023
525283/GMP/2020 CCY.S.P Industries (M) Sdn. BhdLot 3, 5 & 7, Jalan P/7, Section 13, Kawasan Pendustrian Bandar Baru Bangi, 43000, Kajang, Selangor - MalaysiaMalaysia11/23/2020RT131458, RT13442411/26/202011/26/2023Non- Beta LactamNon- Beta Lactam: Tablets (Coated and Uncoated)
Hard Gelatin Capsules
Oral Liquids
Creams, Gels and Ointments
Suppositories and Pessaries
SVP Liquids
Non- Beta Lactam: Tablets (Coated and Uncoated)
Hard Gelatin Capsules
Oral Liquids
Creams, Gels and Ointments
Suppositories and Pessaries
SVP Liquids
NoneDenis William Mwesigwa11/26/2023
526284/GMP/2020 CCPT Sanbe Farma (Unit 2)Jalan Mahar Martanegara No. 162 (Jalan Leuwigajah No. 162) RT.01 RW.12, Kelurahan Baros, Kecamatan Cimahi Tengah, Kota Cimahi 40522 - IndonesiaIndonesia9/18/2020RT13212711/26/202011/26/2023Beta Lactam (Penicillins), Beta Lactam (Cephalosporins)Beta Lactam (Penicillins): Tablets
Hard gelatin capsules
Dry powder for oral suspension
Powders for injection (SVP)
, Beta Lactam (Cephalosporins): Tablets
Hard gelatin capsules
Dry powder for oral suspension
Powders for injection (SVP)
Beta Lactam (Penicillins): Tablets
Hard gelatin capsules
Dry powder for oral suspension
Powders for injection (SVP)
, Beta Lactam (Cephalosporins): Tablets
Hard gelatin capsules
Dry powder for oral suspension
Powders for injection (SVP)
NoneDenis William Mwesigwa11/26/2023
527288/GMP/2020 CCEncore Healthcare Private LimitedD-5, MIDC Area, Paithan- 431148, Dist. Aurangabad, Maharashtra - IndiaIndia8/15/2018RT10038911/27/202011/27/2023Non- Beta LactamNon- Beta Lactam: Capsules
Oral Liquids
Tablets
Non- Beta Lactam: Capsules
Oral Liquids
Tablets
NoneDenis William Mwesigwa11/27/2023
528289/GMP/2020 CCAurobindo Pharma Limited, Unit VISy. No.: 329/39 & 329/47, Chitkul (V), Patancheru (M) SangaReddy Dist - 502 307, Telangana State - IndiaIndia11/23/2020RT13443611/27/202011/27/2023Beta Lactam (Cephalosporin)Beta Lactam (Cephalosporin): Small Volume Parenteral powders (Aseptically prepared)
Tablets
Hard Gelatin Capsules
Dry powders for oral suspensions
Beta Lactam (Cephalosporin): Small Volume Parenteral powders (Aseptically prepared)
Tablets
Hard Gelatin Capsules
Dry powders for oral suspensions
NoneDenis William Mwesigwa11/27/2023
529290/GMP/2020 DRM/s. Annora Pharma Private LimitedSy. No. 261, Annaram Village, Gummadidala Mandal, Sangareddy District, Telengana State – 502313, IndiaIndia24/MD/TS/2016/F/G dated 20th October 20162/7/2020RT12321812/8/202012/8/2023Non-Beta LactamNon-Beta Lactam: Hard Gelatin Capsules
Liquids for internal use
Suppositories
Tablets
Non-Beta Lactam: Hard Gelatin Capsules
Liquids for internal use
Suppositories
Tablets
NoneDenis William Mwesigwa12/8/2023
530291/GMP/2020 DRMylan Laboratories SASRoute de Belleville, Lieu dit Maillard, 01400 Chatillon-sur-Chalaronne, FranceFranceM 15/195 – MOD16/26/2019RT11224812/8/202012/8/2023Non-Beta LactamNon-Beta Lactam: Hard Gelatin Capsules
Tablets
Non-Beta Lactam: Hard Gelatin Capsules
Tablets
NoneDenis William Mwesigwa12/8/2023
531292/GMP/2020 DRPatheon Inc2100, Syntex Court, Mississauga Ontario, Canada L5N 7K9 - CanadaCanada100074-A6/24/2020RT12800512/8/202012/8/2023Non-Beta LactamNon-Beta Lactam:
Tablets
Non-Beta Lactam:
Tablets
NoneDenis William Mwesigwa12/8/2023
532293/GMP/2020 DRAlcon Couvreur BelgiumAlcon-Couvreur NV, Rijksweg 14, Puurs, 2870 - BelgiumBelgium100074-A6/25/2020RT12826212/8/202012/8/2023Non-Beta LactamNon-Beta Lactam: Semi-solids (Aseptically prepared)
Small Volume Liquids (Aseptically prepared)
Small Volume Liquids (Terminally Sterilized)
Non-Beta Lactam: Semi-solids (Aseptically prepared)
Small Volume Liquids (Aseptically prepared)
Small Volume Liquids (Terminally Sterilized)
NoneDenis William Mwesigwa12/8/2023
533294/GMP/2020 DRMerck S.LPoligono Merck S/N 08100 Mollet del Valles Barcelona, SpainSpain3086/1/2020RT12711012/8/202012/8/2023CephalosporinCephalosporin: TabletsCephalosporin: TabletsNoneDenis William Mwesigwa12/8/2023
534295/GMP/2020 DRJanssen - Cilag International NVTurnhoutseweg 30 B-2340, Beerse - BelgiumBelgium2 IMP6/11/2018RT9694112/8/202012/8/2023Non-Beta LactamNon-Beta Lactam: Liquids for internal useNon-Beta Lactam: Liquids for internal useNoneDenis William Mwesigwa12/8/2023
535296/GMP/2020 DRSanofi Winthrop Industrie - Ambares1 rue de la vierge, 33565 Carbon- Blanc Cedex - FranceFrance8/10/2018RT7207612/8/202012/8/2023Non-Beta LactamNon-Beta Lactam: Hard Gelatin Capsules
Small Volume Liquids (Aseptically prepared)
Small Volume Liquids (Terminally Sterilized)
Non-Beta Lactam: Hard Gelatin Capsules
Small Volume Liquids (Aseptically prepared)
Small Volume Liquids (Terminally Sterilized)
NoneDenis William Mwesigwa12/8/2023
536297/GMP/2020 DRSanofi - Aventis Deutschland GMBHBruningstrasse 50, D-65926 Frankfurt AM Main, GermanyGermanyDE_HE_01_MIA_2019_00061/14/2020FU19/36212/8/202012/8/2023Biologicals, CytotoxicBiologicals: Small Volume Parenterals (Aseptically filled), Cytotoxic: Small Volume Parenterals (Aseptically filled)Biologicals: Small Volume Parenterals (Aseptically filled), Cytotoxic: Small Volume Parenterals (Aseptically filled)NoneDenis William Mwesigwa12/8/2023
537298/GMP/2020 DRVogen Laboratories Limited - Site A70, M. Heracleous str., Ayios Athanasios Industrial Area, Limassol - CyprusCyprus357/10/2020RT12940112/8/202012/8/2023PenicillinPenicillin: Hard Gelatin Capsules
Powders for oral suspension
Penicillin: Hard Gelatin Capsules
Powders for oral suspension
NoneDenis William Mwesigwa12/8/2023
538299/GMP/2020 CCNipro JMI Pharma LimitedRajendrapur, Chauddagram, Comilla - BangladeshBangladesh11/26/2020RT13454312/9/202012/9/2023Non-Beta LactamNon-Beta Lactam: Tablets (coated and uncoated)
Hard Gelatin Capsules
Liquids in hard Gelatin Capsules
Dry powders for oral suspension
Oral liquid line
Non-Beta Lactam: Tablets (coated and uncoated)
Hard Gelatin Capsules
Liquids in hard Gelatin Capsules
Dry powders for oral suspension
Oral liquid line
NoneDenis William Mwesigwa12/9/2023
539310/GMP/2020 CCLosan Pharma GmbHOtto-Hahn-Str. 13, 79395 Neuenburg – GermanyGermanyDE_BW_01_MIA_2020_00386/11/2020RT12763712/9/202012/9/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa12/9/2023
540311/GMP/2020 CCMerck Sharp & Dohme Corp770 Sumneytown Pike, West Pint, Pennsylvania, 19486 - United States of AmericaUnited States Of America10/28/2020FU20/25112/9/202012/9/2023Vaccines (Gardasil & Rotateq)Vaccines (Gardasil & Rotateq): Sterile Small Volume LiquidsVaccines (Gardasil & Rotateq): Sterile Small Volume LiquidsNoneDenis William Mwesigwa12/9/2023
541312/GMP/2020 CCAlthea Pharma Private LimitedWorks: Plot No. 374, Shed No. 'E', Alpha Indl. Park, Athiawad, Dabhel, Nani Daman - 396210 (U.T.) – IndiaIndia11/16/2020RT13427112/9/202012/9/2023Non-Beta LactamNon-Beta Lactam: Large Volume Parenteral Solutions
Small Volume Parenteral Solutions
Non-Beta Lactam: Large Volume Parenteral Solutions
Small Volume Parenteral Solutions
NoneDenis William Mwesigwa12/9/2023
542313/GMP/2020 CCAuronext Pharma Private LimitedA-1128, RIICO Industrial Area, Phase-III, Bhiwadi 301019 – IndiaIndia12/7/2020RT134871, RT13487212/9/202012/9/2023Beta Lactam (Carbapenems)Beta Lactam (Carbapenems): Aseptically filled SVP dry powder vials
Lyophilized SVP Powders in vials
Beta Lactam (Carbapenems): Aseptically filled SVP dry powder vials
Lyophilized SVP Powders in vials
NoneDenis William Mwesigwa12/9/2023
543314/GMP/2020 CCMontajat Pharmaceuticals (Agrochemicals Division)Street 20, 2nd Industrial City, P.O. Box - 4248, Damman 31491 – Kingdom of Saudi ArabiaSaudi Arabia12/9/2020RT13496212/10/202012/10/2023Non-Beta Lactam (Vet)Non-Beta Lactam (Vet): Ectoparasiticide External LiquidsNon-Beta Lactam (Vet): Ectoparasiticide External LiquidsNoneDenis William Mwesigwa12/10/2023
544315/GMP/2020 CCFatro S.p.AVia Molino Emili, 2 Maclodio (BS) 25030 – ItalyItaly7/3/2020RT12930812/10/202012/10/2023Non-Beta Lactam (Vet)Non-Beta Lactam (Vet): Veterinary Vaccines (Live Vaccines, Freeze dried vaccines, Inactivated Vaccines and Marek Virus Vaccine) under the following dosage forms;
1. Small Volume Parenterals - Solutions and Lyophilised powders in Single and Multidoses
2. Large Volume Parenterals - Solutions and Lyophilised powders in Single and Multidoses
3. Solutions and Suspensions
4. Freeze Dried Powders
Non-Beta Lactam (Vet): Veterinary Vaccines (Live Vaccines, Freeze dried vaccines, Inactivated Vaccines and Marek Virus Vaccine) under the following dosage forms;
1. Small Volume Parenterals - Solutions and Lyophilised powders in Single and Multidoses
2. Large Volume Parenterals - Solutions and Lyophilised powders in Single and Multidoses
3. Solutions and Suspensions
4. Freeze Dried Powders
NoneDenis William Mwesigwa12/10/2023
545316/GMP/2020 CCAgio Pharmaceuticals LimitedT- 81, 82, MIDC, Bhosari, Pune - 411 026, Maharashtra State, IndiaIndia10/26/2020RT132723, RT132724, RT13346512/14/202012/14/2023Non-Beta LactamNon-Beta Lactam: SVP solutions
Cream/ ointment/ Gel
Tablets
Oral liquid formulations
Hard Gelatin Capsule
Oral dry powders packed in sachets
Non-Beta Lactam: SVP solutions
Cream/ ointment/ Gel
Tablets
Oral liquid formulations
Hard Gelatin Capsule
Oral dry powders packed in sachets
NoneDenis William Mwesigwa12/14/2023
546317/GMP/2020 CCBaxter Pharmaceuticals India Private LimitedChacharwadi - Vasana, Ahmedabad, IN 382213, IndiaIndia10/27/2020RT13351212/14/202012/14/2023Non-Beta LactamNon-Beta Lactam: Small Volume Parenterals (vials and ampoules)
Small Volume Parenterals (emulsions and aqueous solutions in glass bottles)
Non-Beta Lactam: Small Volume Parenterals (vials and ampoules)
Small Volume Parenterals (emulsions and aqueous solutions in glass bottles)
NoneDenis William Mwesigwa12/14/2023
547318/GMP/2020 CCTIL Healthcare Private LimitedPlot No. 100 West, R 5, South, Sri City SEZ, Cherivi Village, Irrugulam Post, Satyavedu Manal, Chittoor District - 517588 Andhra Pradesh, IndiaIndia10/6/2020RT13290912/14/202012/14/2023Non-Beta LactamNon-Beta Lactam: Tablets
Hard gelatin capsules
Oral liquids
Dry powders for oral suspensions in bottles
Dry powders for oral suspension in Sackets
Non-Beta Lactam: Tablets
Hard gelatin capsules
Oral liquids
Dry powders for oral suspensions in bottles
Dry powders for oral suspension in Sackets
NoneDenis William Mwesigwa12/14/2023
548319/GMP/2020 CCAurobindo Pharma Limited, Unit IIISurvey No. 313 & 314, Bachupally (Mandal), Medchal - Malkajgiri (District) - 500090 Telengana (State), IndiaIndia10/15/2020RT13315012/14/202012/14/2023Non-Beta LactamNon-Beta Lactam: Tablets (coated & uncoated)
Hard Gelatin Capsules
Oral liquids (Suspensions & Syrups)
Non-Beta Lactam: Tablets (coated & uncoated)
Hard Gelatin Capsules
Oral liquids (Suspensions & Syrups)
NoneDenis William Mwesigwa12/14/2023
549320/GMP/2020 CCMerck Serono S.P.AVia Delle Magnolie 15 (Loc Frazione Zona Industrialle), 70026 - Modugno (BA) Bari, ItalyItaly10/12/2020RT13294812/14/202012/14/2023Hormones & substances with hormonal activity, Terminally sterilizedHormones & substances with hormonal activity: Small Volume Parenteral (Syringes & Cartridges)
Lyophilized powders., Terminally sterilized: Small Volume Parenterals
Hormones & substances with hormonal activity: Small Volume Parenteral (Syringes & Cartridges)
Lyophilized powders., Terminally sterilized: Small Volume Parenterals
NoneDenis William Mwesigwa12/14/2023
550321/GMP/2020 CCHetero Labs Limited, Unit-IIISurvey No.:51, 22-110, Industrial Development Area Jeedimetla, Hyderabad District, Pin-500055, Telengana, IndiaIndia9/22/2020RT13222812/14/202012/14/2023Non-Beta LactamNon-Beta Lactam: Hard shell capsules
Tablets (coated and Uncoated)
Oral liquids
Non-Beta Lactam: Hard shell capsules
Tablets (coated and Uncoated)
Oral liquids
NoneDenis William Mwesigwa12/14/2023
551322/GMP/2020 CCOtsuka Pharmaceutical India Private LimitedSurvey No. 199 to 201 & 208 to 210 Village - Vasana Chacharwadi, Taluka - Sanand Dist. Ahmedabad – 382213, IndiaIndia8/24/2020RT13083912/14/202012/14/2023Non-Beta LactamNon-Beta Lactam: Large Volume Parenterals [Non PVC bags (Single and Multi-chamber), Plastic bottles & Glass bottles]
Small Volume Parenterals (Plastic Ampoules)
Non-Beta Lactam: Large Volume Parenterals [Non PVC bags (Single and Multi-chamber), Plastic bottles & Glass bottles]
Small Volume Parenterals (Plastic Ampoules)
NoneDenis William Mwesigwa12/14/2023
552323/GMP/2020 CCAkums Drugs & Pharmaceuticals LimitedPlant - 1, Plot No. 19, 20 & 21, Sector - 6A, IIE, SIDCUL, Ranipur Distt.: Haridwar, (Uttrakhand), IndiaIndia8/12/2020FU20/08012/14/202012/14/2023Non-Beta LactamNon-Beta Lactam: Hard shell capsules
Tablets
Non-Beta Lactam: Hard shell capsules
Tablets
NoneDenis William Mwesigwa12/14/2023
553324/GMP/2020 CCAkums Drugs & Pharmaceuticals LimitedPlot No. 47, 48, Sector 6A, IIE, SIDCUL Haridwar, Uttrakhand – 249403, IndiaIndia8/12/2020FU20/07912/14/202012/14/2023Non-Beta Lactam (Hormonal products)Non-Beta Lactam (Hormonal products): Tablets
Hard gelatin capsules
Soft gelatin capsules
Small volume parenteral (Ampoules /Vials)
Gels /Ointments /Creams
Non-Beta Lactam (Hormonal products): Tablets
Hard gelatin capsules
Soft gelatin capsules
Small volume parenteral (Ampoules /Vials)
Gels /Ointments /Creams
NoneDenis William Mwesigwa12/14/2023
554326/GMP/2020 CCIpca Laboratories LimitedPlot No. 255/1, Athal, Silvassa 396230, Union Territory of Dadra Nagar & Haveli - IndiaIndia11/23/2020RT13442612/14/202012/14/2023Non-Beta LactamNon-Beta Lactam: Tablets (Coated & Uncoated)Non-Beta Lactam: Tablets (Coated & Uncoated)NoneDenis William Mwesigwa12/14/2023
555327/GMP/2020 CCIpca Laboratories LimitedPlot No. T-139, MIDC, Industrial Estate, Tarapur, Boisor, Dist - Palghar Thane 401 506 Maharashtra, IndiaIndia9/25/2020RT132385, FU20/18412/21/202012/21/2023Non-Beta LactamNon-Beta Lactam: Tablets (Coated & Uncoated)Non-Beta Lactam: Tablets (Coated & Uncoated)NoneDenis William Mwesigwa12/21/2023
556328/GMP/2020 DRAesica Pharmaceuticals GmbHPrimary and Secondary packaging Address: Mittelstr. 15, 40789 Monheim am Rhein.
Batch release address: Alfred-Nobel-Str. 10. 40789 Monheim am Rhein, Germany
GermanyDE_NW_03_MIA_2020_002910/14/2020RT11885412/21/202012/21/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa12/21/2023
557329/GMP/2020 DRWorld Medicine Ilac San ve Tic A.S.15 Temmuz Mahallesi, Cami Yolu Caddesi, No: 50 K:4 WM Plaza, Gunesil-Bagcilar / Instanbul - TurkeyTurkeyTR/UY/2019/12-01/13/2020RT12154812/16/202012/16/2023Non-Beta LactamNon-Beta Lactam: Small Volume Liquids (Aseptically Prepared)
Tablets
Capsules, hard shell
Semi-solids (Creams, Ointments & Gels)
Suppositories
Non-Beta Lactam: Small Volume Liquids (Aseptically Prepared)
Tablets
Capsules, hard shell
Semi-solids (Creams, Ointments & Gels)
Suppositories
NoneDenis William Mwesigwa12/16/2023
558330/GMP/2020 CCUnichem Laboratories LimitedC-31, 32 & D-10, Industrial Area, Meerut Road, Ghaziabad (U.P.) 201003 - IndiaIndia11/18/2020RT13433312/21/202012/21/2023Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
NoneDenis William Mwesigwa12/21/2023
559332/GMP/2020 CCChina National Medicines Guorui Pharmaceutical Company LimitedCaoyang East Road, Huainan Economical and Technological Development Zone, Huainan City Anhui Province - ChinaChina6/5/2020RT12730012/29/202012/29/2023Non-Beta Lactam,
Beta lactam (Cephalosporins)
Non-Beta Lactam: Small volume parenteral solutions
Small volume parenteral powders,
Beta lactam (Cephalosporins): Small volume parenteral solutions
Small volume parenteral powders
Non-Beta Lactam: Small volume parenteral solutions
Small volume parenteral powders,
Beta lactam (Cephalosporins): Small volume parenteral solutions
Small volume parenteral powders
NoneDenis William Mwesigwa12/29/2023
560333/GMP/2020 CCPenCef Pharma GmbHBreitenbachstraBe 13-14, 13509 Berlin - GermanyGermany12/18/2020RT13517912/29/202012/29/2023Beta Lactam (Human)Beta Lactam (Human): Tablets
Oral Powders for Oral Suspension
Hard Gelatin Capsules
Beta Lactam (Human): Tablets
Oral Powders for Oral Suspension
Hard Gelatin Capsules
NoneDenis William Mwesigwa12/29/2023
561334/GMP/2020 CCMylan Laboratories LimitedPlot No. H-12 & H-13, MIDC, Waluj, Aurangabad, Maharashtra, India - 431136 - IndiaIndia12/21/2020FU20/31712/29/202012/29/2023Non-Beta LactamNon-Beta Lactam: Tablets (Coated and Uncoated)
Hard Gelatin Capsules
Non-Beta Lactam: Tablets (Coated and Uncoated)
Hard Gelatin Capsules
NoneDenis William Mwesigwa12/29/2023
562001/GMP/2021 CCHetero Biopharma LimitedSy. No. 458 (Part), TSIIC - Formulation SEZ, Polepally (Village), Jadcherla (Mandal) Mahaboobnagar (District), 509301, Telangana State IndiaIndia12/23/2020RT135634, RT135635, RT1356361/5/20211/5/2024Biosimilar productsBiosimilar products: Small Volume Parenterals (Pre-filled syringes and vials)Biosimilar products: Small Volume Parenterals (Pre-filled syringes and vials)NoneDenis William Mwesigwa1/5/2024
563002/GMP/2021 CCFresenius Kabi Manufacturing SA (Pty) Limited6 Gibaud Road, Korsten, 6020, Port Elizabeth, South AfricaSouth Africa7/11/2017RT848081/19/20211/19/2024Non-Beta lactam, Hormones Non-Beta lactam: Small Volume Parenteral Solutions packed in Ampoules & Vials.
Large volume parenteral solutions-Freeflex
, Hormones: Small volume Parenteral solutions packed in vials
Non-Beta lactam: Small Volume Parenteral Solutions packed in Ampoules & Vials.
Large volume parenteral solutions-Freeflex
, Hormones: Small volume Parenteral solutions packed in vials
NoneDenis William Mwesigwa1/19/2024
564004/GMP/2021 CCChinoin Pharmaceutical and Chemical Works Private Company Limited (Short Name: Chinoin Private Company Limited)H-2112 Veresegyhaz, Levai u. 5. - HungaryHungaryHU-M-CHIN7/7/2020RT1290671/6/20211/6/2024Non-Beta lactamNon-Beta lactam: Tablets
Capsules, Hard shell
Powders/Granules
Non-Beta lactam: Tablets
Capsules, Hard shell
Powders/Granules
NoneDenis William Mwesigwa1/6/2024
565005/GMP/2021 CCFresenius Kabi Austria GmbHHafnerstrasse 36, 8055 Graz - AustriaAustria4821466/30/2020RT1283531/6/20211/6/2024Non-Beta lactamNon-Beta lactam: Large Volume Liquids (Aseptically prepared)
Large Volume Liquids (Terminally sterilized)
Small Volume Liquids (Aseptically prepared)
Small Volume Liquids (Terminally sterilized)
Non-Beta lactam: Large Volume Liquids (Aseptically prepared)
Large Volume Liquids (Terminally sterilized)
Small Volume Liquids (Aseptically prepared)
Small Volume Liquids (Terminally sterilized)
NoneDenis William Mwesigwa1/6/2024
566006/GMP/2021 CCFredun Pharmaceuticals Limited14, 15, 16 Zorabian Industrial Complex, Vevoor, Palghar 401 404 - IndiaIndia6/13/2019RT1117632/5/20212/5/2024Non-Beta lactamNon-Beta lactam: Tablets
Hard Gelatin Capsules
Dry powders for oral suspension
Non-Beta lactam: Tablets
Hard Gelatin Capsules
Dry powders for oral suspension
NoneDenis William Mwesigwa2/5/2024
567007/GMP/2021 CCRemedica LimitedAharnon Street, Limassol Industrial Estate, 3056 Limassol - CyprusCyprus296/22/2020RT1279201/8/20211/8/2024Non-Beta lactam, Hormones, Penicillins, Antineoplasic & Immunomodulators, CephalosporinNon-Beta lactam: Tablets
Capsules, Hard shell
Semi-solids
Liquids for internal use, Hormones: Tablets, Penicillins: Tablets
Capsules, Hard shell, Antineoplasic & Immunomodulators: Tablets, Cephalosporin: Capsules, Hard shell
Powders for Oral Suspension
Non-Beta lactam: Tablets
Capsules, Hard shell
Semi-solids
Liquids for internal use, Hormones: Tablets, Penicillins: Tablets
Capsules, Hard shell, Antineoplasic & Immunomodulators: Tablets, Cephalosporin: Capsules, Hard shell
Powders for Oral Suspension
NoneDenis William Mwesigwa1/8/2024
568010/GMP/2021 CCAdvance Pharma GmbHWallenroder StraBe 12-14, 13435 Berlin - GermanyGermany2/2/2021RT1367402/5/20212/5/2024Non-Beta lactamNon-Beta lactam: TabletsNon-Beta lactam: TabletsNoneDenis William Mwesigwa2/5/2024
569011/GMP/2021 CCDyntec Spol. S.r.o.Prazska 328, 411 55 Terezin – Czech RepublicCzech Republic510/2018/RHV8/15/2019RT115513 / RT1155141/29/20211/29/2024VaccinesVaccines: Large Volume Liquids (Aseptically prepared)
Small Volume Liquids (Aseptically prepared)
Lyophilisates (Aseptically prepared)
Vaccines: Large Volume Liquids (Aseptically prepared)
Small Volume Liquids (Aseptically prepared)
Lyophilisates (Aseptically prepared)
NoneDenis William Mwesigwa1/29/2024
570012/GMP/2021 CCHaupt Pharma Munster GmbHSchleebruggenkamp 15, 48159 Munster - GermanyGermany2/2/2021RT1367382/5/20212/5/2024Non-Beta LactamNon-Beta Lactam: Tablets (Hormones)Non-Beta Lactam: Tablets (Hormones)NoneDenis William Mwesigwa2/5/2024
571013/GMP/2021 CCSolupharm Pharmazeutische Erzeugnisse GmbHIndustriestr. 3, 34212 Melsungen - GermanyGermany2/2/2021RT1367392/5/20212/5/2024Non-Beta LactamNon-Beta Lactam: Small Volume Parenterals – Terminally sterilizedNon-Beta Lactam: Small Volume Parenterals – Terminally sterilizedNoneDenis William Mwesigwa2/5/2024
572014/GMP/2021 CCSwiss Garnier Life Sciences21-23 Industrial Area Mehatpur Dist Una, Himachal Pradesh, 174315 - IndiaIndia2/3/2021RT1367612/5/20212/5/2024Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin capsules
Oral Liquid
Oral powder in sachets
Ointments, Gels and Creams
Non-Beta Lactam: Tablets
Hard Gelatin capsules
Oral Liquid
Oral powder in sachets
Ointments, Gels and Creams
NoneDenis William Mwesigwa2/5/2024
573015/GMP/2021 CCRaptakos, Brett & Company Limited1st Pokhran Road, Thane 400606, MIDC, Maharashtra, IndiaIndia2/3/2021RT1367792/5/20212/5/2024Non-Beta LactamNon-Beta Lactam: Oral Liquids
Topical Ointments & Creams
Non-Beta Lactam: Oral Liquids
Topical Ointments & Creams
NoneDenis William Mwesigwa2/5/2024
574016/GMP/2021 CCZen Pharma Private Limited75/1, G.I.D.C. Vapi - 396195, Gujarat - IndiaIndia2/3/2021RT1367802/5/20212/5/2024Non-Beta Lactam, Beta lactam (Cephalosporin)Non-Beta Lactam: Small Volume Parenterals (Ampoules & Vials)
External preparations (Ointments & Topical solutions), Beta lactam (Cephalosporin): Small Volume Parenterals (Dry powder for Injection)
Non-Beta Lactam: Small Volume Parenterals (Ampoules & Vials)
External preparations (Ointments & Topical solutions), Beta lactam (Cephalosporin): Small Volume Parenterals (Dry powder for Injection)
NoneDenis William Mwesigwa2/5/2024
575017/GMP/2021 CCPrivate Joint Stock Company "INDAR"5, Zroshuvalna Str. Kyiv, 02099 - UkraineUkraineAB No. 59801811/30/2018RT1038682/5/20212/5/2024Biotechnology productsBiotechnology products: Small Volume Liquids (Aseptically prepared)Biotechnology products: Small Volume Liquids (Aseptically prepared)NoneDenis William Mwesigwa2/5/2024
576019/GMP/2021 CCZhejiang Huahai Pharmaceutical Company LimitedXungiao, Linhai, Zhejiang 317024 – People’s Republic of ChinaChina7/24/2019RT1143072/8/20212/8/2024Non-Beta LactamNon-Beta Lactam: Oral Coated Tablets (Efavirenz & Raltegravir)Non-Beta Lactam: Oral Coated Tablets (Efavirenz & Raltegravir)NoneDenis William Mwesigwa2/8/2024
577020/GMP/2021 CCRiva Pharma S.A.E.St.6, Public Free Zone, Nasr City - EgyptEgypt3/20/2019RT1081232/8/20212/8/2024Beta Lactam, Non-Beta LactamBeta Lactam: Oral Dry Powders
Hard Gelatin Capsules, Non-Beta Lactam: Oral Dry Powders
Hard Gelatin Capsules
Beta Lactam: Oral Dry Powders
Hard Gelatin Capsules, Non-Beta Lactam: Oral Dry Powders
Hard Gelatin Capsules
NoneDenis William Mwesigwa2/8/2024
578021/GMP/2021 CCMerck SanteCentre De Production, 2, Rue du Pressoir Vert - 45400 Semoy - FranceFrance8/31/2020RT1311482/8/20212/8/2024Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa2/8/2024
579022/GMP/2021 CCFisio Pharma S.R.L.Nucleo Industriale, 84020, Palomonte (SA) - ItalyItaly9/2/2020RT1312512/8/20212/8/2024Non-Beta LactamNon-Beta Lactam: Small Volume Parenteral LiquidsNon-Beta Lactam: Small Volume Parenteral LiquidsNoneDenis William Mwesigwa2/8/2024
580023/GMP/2021 CCBayer Bitterfeld GmbHOrtsteil Greppin Salegaster Chaussee 1, 06803 Bitterfeld, Wolfen - GermanyGermany9/11/2020RT1315832/8/20212/8/2024Non-Beta LactamNon-Beta Lactam: Tablets (Coated & Uncoated)Non-Beta Lactam: Tablets (Coated & Uncoated)NoneDenis William Mwesigwa2/8/2024
581024/GMP/2021 CCGlaxo Wellcome S.A.Avenida Extremadura 3, 09400 Aranda De Duero - SpainSpain9/16/2020RT1320592/8/20212/8/2024Non-Beta LactamNon-Beta Lactam: Tablets (Coated & Uncoated)Non-Beta Lactam: Tablets (Coated & Uncoated)NoneDenis William Mwesigwa2/8/2024
582025/GMP/2021 CCNovartis Farmaceutica SARonda Santa Maria 158, 08210 Barbera del Valles, Barcelona - SpainSpain9/17/2020FU20/1662/8/20212/8/2024Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa2/8/2024
583026/GMP/2021 CCNovartis Pharma Produktions GmbHOeflingerstrasse 44, 79664 Wehr - GermanyGermany9/17/2020FU20/1652/8/20212/8/2024Non-Beta LactamNon-Beta Lactam: Hard Gelatin Capsules
Semi-solids
Tablets
Non-Beta Lactam: Hard Gelatin Capsules
Semi-solids
Tablets
NoneDenis William Mwesigwa2/8/2024
584027/GMP/2021 CCNeon Laboratories LimitedPlot No. 29 to 32, 57 & 60, The Palghar Taluka Industrial Co-operative Estate Limited., Boisar Road, Palghar 401 404, Maharashtra State - IndiaIndia2/10/2021RT137167, RT137168, RT133692, RT1336932/17/20212/17/2024Non-Beta Lactam, Cytotoxic, CephalosporinNon-Beta Lactam: SVP Liquids
SVP Powders for Injection, Cytotoxic: SVP Liquids
Hard Gelatin Capsules
Tablets, Cephalosporin: SVP Powders for injection
Tablets
Non-Beta Lactam: SVP Liquids
SVP Powders for Injection, Cytotoxic: SVP Liquids
Hard Gelatin Capsules
Tablets, Cephalosporin: SVP Powders for injection
Tablets
NoneDenis William Mwesigwa2/17/2024
585028/GMP/2021 CCAndersonBrecon (UK) Limited, Units 2-7Units 2-7, Wye Valley Business Park, Brecon Road, Hay-on-Wye, Hereford, HR3 5PG – United KingdomUnited Kingdom4/12/2019RT1093822/17/20212/17/2024Non-Beta LactamNon-Beta Lactam: Capsules, hard shellNon-Beta Lactam: Capsules, hard shellNoneDenis William Mwesigwa2/17/2024
586029/GMP/2021 CCC.P.M. Contract Pharma GmbH & Company KG.Fruhlingstr. 7, 83620 Feldkirchen, Westerham - GermanyGermanyDE_BY_04_MIA_2020_01199/9/2019RT1162912/17/20212/17/2024Non-Beta LactamNon-Beta Lactam: Semi-solids (Creams, Ointments, Lotions & Gels)Non-Beta Lactam: Semi-solids (Creams, Ointments, Lotions & Gels)NoneDenis William Mwesigwa2/17/2024
587030/GMP/2021 CCGranules India LimitedSy. No. 160/A, 161/E, 162 & 174/A Gagillapur Village, Dundigal-Gandimaisamma Mandal, Medchal Malkhajgiri District - 500043 Telengana - IndiaIndia37/RR/AP/2003/F/R7/16/2020RT1290842/17/20212/17/2024Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa2/17/2024
588031/GMP/2021 CCAndersonBrecon (UK) Limited, Talgarth Site, Unit 8Unit 1 Talgarth Business Park, Trefecca Road, Talgarth, Brecon, LD3 0PQUnited KingdomUK_MIA_117244/12/2019RT1093862/17/20212/17/2024Non-Beta LactamNon-Beta Lactam: Capsules, hard shellNon-Beta Lactam: Capsules, hard shellNoneDenis William Mwesigwa2/17/2024
589032/GMP/2021 CCLABIANA Pharmaceuticals, S.L.U.C/Casanova, 27-31, 08757 Corbera de Llobregat BarcelonaBarcelona1892/12/2019RT1069632/17/20212/17/2024Non-Beta LactamNon-Beta Lactam: Small Volume Liquids (Terminally sterilized)
Powders/granules
Non-Beta Lactam: Small Volume Liquids (Terminally sterilized)
Powders/granules
NoneDenis William Mwesigwa2/17/2024
590033/GMP/2021 CCThe Searle Company LimitedF-319, S.I.T.E Opposite K.E.S.C, Power Station Karachi - 75530, PakistanPakistan1/19/2021RT1360652/19/20212/19/2024Non-Beta LactamNon-Beta Lactam: Oral Liquids
Hard Gelatin Capsules
Tablets
Small volume Parenterals
Powders in sachets
Non-Beta Lactam: Oral Liquids
Hard Gelatin Capsules
Tablets
Small volume Parenterals
Powders in sachets
NoneDenis William Mwesigwa2/19/2024
591034/GMP/2021 CCWockhardt LimitedPlot No. 57, Village Kunjhal, P.O. Barotiwala, The. Baddi Distt Solan (H.P.) - IndiaIndia2/12/2021RT1373002/19/20212/19/2024Non-Beta LactamNon-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Oral Liquids
Creams and Ointments
Non-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Oral Liquids
Creams and Ointments
NoneDenis William Mwesigwa2/19/2024
592035/GMP/2021 CCGlaxo Wellcome ProductionZ.I de La Peyenniere, 53100 Mayenne, FranceFrance9/16/2020RT1320602/20/20212/20/2024Beta LactamBeta Lactam: Oral powders for suspension
Tablets
Hard Gelatin Capsules
Granules in sachets
Beta Lactam: Oral powders for suspension
Tablets
Hard Gelatin Capsules
Granules in sachets
NoneDenis William Mwesigwa2/20/2024
593037/GMP/2021 CCLaboratoires Chaix Et Du Marais (CDM Lavoiser)2 Allee Henri Hugon - Zone industrielle des Gailletrous 41260 La Chaussee Saint Victor - FranceFranceMM 15/322 issued on 21/10/201512/16/2019FU19/3323/3/20213/3/2024Non-Beta LactamNon-Beta Lactam: Large Volume Liquids (Terminally sterilized)
Small Volume Liquids (Terminally sterilized)
Non-Beta Lactam: Large Volume Liquids (Terminally sterilized)
Small Volume Liquids (Terminally sterilized)
NoneDenis William Mwesigwa3/3/2024
594038/GMP/2021 CCOdyssea Pharma SPRLRue du Travail 16, 4460 Grace-Hollogne - BelgiumBelgium1669 H7/6/2020RT1290543/3/20213/3/2024HormonesHormones: Implants (Terminally sterilized)Hormones: Implants (Terminally sterilized)NoneDenis William Mwesigwa3/3/2024
595039/GMP/2021 CCElys Chemical Industries Limited (Unit 2)Plot no. LR.209/15128, Mombasa road, P.O. Box 40411, 00100 Nairobi - KenyaKenya7/3/2020RT129049, RT1292983/3/20213/3/2024Beta Lactam (Penicillin)Beta Lactam (Penicillin): Tablets (Uncoated)
Hard Gelatin Capsules
Powders for oral suspension
Beta Lactam (Penicillin): Tablets (Uncoated)
Hard Gelatin Capsules
Powders for oral suspension
NoneDenis William Mwesigwa3/3/2024
596040/GMP/2021 CCGulf Pharmaceutical Industries - Julphar plants (JI, JII, JIII, JIV, JVI, JVIII, JIX, JX, JX, JXI, JXII)Julphar. Digdaga Area, Airport Road, P.O Box No. 997 United Arab EmiratesUnited Arab Emirates1/6/2021RT122011, RT122012, RT135839, RT1358383/3/20213/3/2024Non-Beta Lactam, Beta LactamNon-Beta Lactam: SVP solutions and Lyophilized powders for injection
Tablets (Coated & Uncoated)
Hard gelatin capsules
Powders for oral suspension
Oral Liquids (Syrups, Suspensions & Drops)
Creams, Ointments & Suppositories, Beta Lactam: SVP Cephalosporin powders for injection
Cephalosporin Tablets (Coated & Uncoated)
Cephalosporin hard gelatin capsules
Cephalosporin powders for oral suspension
Penicillin Tablets (Coated & Uncoated)
Penicillin hard gelatin capsules
Penicillin powders for oral suspension
Non-Beta Lactam: SVP solutions and Lyophilized powders for injection
Tablets (Coated & Uncoated)
Hard gelatin capsules
Powders for oral suspension
Oral Liquids (Syrups, Suspensions & Drops)
Creams, Ointments & Suppositories, Beta Lactam: SVP Cephalosporin powders for injection
Cephalosporin Tablets (Coated & Uncoated)
Cephalosporin hard gelatin capsules
Cephalosporin powders for oral suspension
Penicillin Tablets (Coated & Uncoated)
Penicillin hard gelatin capsules
Penicillin powders for oral suspension
NoneDenis William Mwesigwa3/3/2024
597041/GMP/2021 CCSvizera Labs Private LimitedD16/6, TTC Industrial Area, MIDC, Turbhe, Navi Mumbai 400073 - IndiaIndia10/19/2020RT1332553/3/20213/3/2024Non-Beta LactamNon-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Non-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
NoneDenis William Mwesigwa3/3/2024
598042/GMP/2021 CCDawa LimitedPlot No. 7879/8, Babadogo Road, Ruaraka Nairobi - KenyaKenya2/4/2021RT136106, RT1368043/3/20213/3/2024Non-Beta Lactam, Beta Lactam (Penicillins)Non-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Oral Liquids – Syrups & Suspensions
Powders for oral suspension
Creams, Ointments & External solutions
, Beta Lactam (Penicillins): Hard Gelatin Capsules
Powders for oral suspension
Non-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Oral Liquids – Syrups & Suspensions
Powders for oral suspension
Creams, Ointments & External solutions
, Beta Lactam (Penicillins): Hard Gelatin Capsules
Powders for oral suspension
NoneDenis William Mwesigwa3/3/2024
599043/GMP/2021 CCCipla Limited Indore (Unit I, II, III, IV).Plot No. 9 & 10 Indore Special Economic Zone, Phase-II, Pithampur, District Dhar, Pin code: 454775, Madhya Pradesh - IndiaIndia3/2/2021RT138342, RT138343, RT138344, RT1383453/3/20213/3/2024Non-Beta Lactam
(Sterile Products), Non-Beta Lactam
(Non-Sterile Products)
Non-Beta Lactam
(Sterile Products): Form Fill Seal (FFS) SVP; Respules & Eye-drops.
Three piece eye-drop (SVP)
, Non-Beta Lactam
(Non-Sterile Products): Oral liquids
Pressurized Metered dose inhalers
Hard Gelatin Capsules
Tablets coated and uncoated
Sachets
Powder for Inhalation
Nasal Spray
Non-Beta Lactam
(Sterile Products): Form Fill Seal (FFS) SVP; Respules & Eye-drops.
Three piece eye-drop (SVP)
, Non-Beta Lactam
(Non-Sterile Products): Oral liquids
Pressurized Metered dose inhalers
Hard Gelatin Capsules
Tablets coated and uncoated
Sachets
Powder for Inhalation
Nasal Spray
NoneDenis William Mwesigwa3/3/2024
600045/GMP/2021 CCEskayef Pharmaceutical Limited400 Squibb Road, Tongi Industrial Area, Gazipur - BangladeshBangladesh3/2/2021RT134102, RT1383473/17/20213/17/2024 Manufacturing Unit 2: Non-Beta Lactam, FAH Building:
Non-Beta Lactam, Manufacturing Unit 1: Non-Beta Lactam, Liquid Sterile Unit: Non-Beta Lactam, Sterile Unit:
Non-Beta Lactam, Cephalosporin Unit
Manufacturing Unit 2: Non-Beta Lactam: Tablets (coated & uncoated)
Hard Gelatin capsule line
Sachet line
, FAH Building:
Non-Beta Lactam: Tablet (Coated & Uncoated)
Oral Liquids
Large Volume Parenterals (Terminally sterilized) in bottles & bags
, Manufacturing Unit 1: Non-Beta Lactam: Oral Liquids for internal use
Liquids for external use
, Liquid Sterile Unit: Non-Beta Lactam: Small Volume Parenterals in ampoules (Aseptic & Terminally sterilized), Sterile Unit:
Non-Beta Lactam: Small Volume Parenterals (Liquids & Lyophilized vials)
Large Volume Parenterals (Aseptically filled and terminally sterilized)
Aseptically filled eye drops
, Cephalosporin Unit: Tablet (Coated & Uncoated)
Hard Gelatin capsules
Powders for oral suspension
Sterile powders for injections (Vials) – Aseptically filled
Manufacturing Unit 2: Non-Beta Lactam: Tablets (coated & uncoated)
Hard Gelatin capsule line
Sachet line
, FAH Building:
Non-Beta Lactam: Tablet (Coated & Uncoated)
Oral Liquids
Large Volume Parenterals (Terminally sterilized) in bottles & bags
, Manufacturing Unit 1: Non-Beta Lactam: Oral Liquids for internal use
Liquids for external use
, Liquid Sterile Unit: Non-Beta Lactam: Small Volume Parenterals in ampoules (Aseptic & Terminally sterilized), Sterile Unit:
Non-Beta Lactam: Small Volume Parenterals (Liquids & Lyophilized vials)
Large Volume Parenterals (Aseptically filled and terminally sterilized)
Aseptically filled eye drops
, Cephalosporin Unit: Tablet (Coated & Uncoated)
Hard Gelatin capsules
Powders for oral suspension
Sterile powders for injections (Vials) – Aseptically filled
NoneDenis William Mwesigwa3/17/2024
601046/GMP/2021 CCCentaur Pharmaceuticals Private LimitedPlant I - Plot No. 3, 5B, 2C Tivim Industrial Estate, Karaswada, Mapusa, Goa - 403 526 – IndiaIndia10/19/2020RT1332504/1/20214/1/2024Non-Beta LactamNon-Beta Lactam: Tablets (Coated & Uncoated)
Syrups
Eye, Ear & Nasal Drops
Non-Beta Lactam: Tablets (Coated & Uncoated)
Syrups
Eye, Ear & Nasal Drops
NoneDenis William Mwesigwa4/1/2024
602047/GMP/2021 CCTriveni Formulations LimitedPlot Nos: 52, 53, 54, 62, 63, 64, Aleap Industrial Estate, Surampalli Village, Gannavaram Mandal, Krishna Dist, Andhra Pradesh, India,521212 - IndiaIndia2/11/2021RT1372394/1/20214/1/2024Non-Beta LactamNon-Beta Lactam: Tablets (Coated & Uncoated)
Capsules (Hard Gelatin Capsules)
Creams and Ointments
Non-Beta Lactam: Tablets (Coated & Uncoated)
Capsules (Hard Gelatin Capsules)
Creams and Ointments
NoneDenis William Mwesigwa4/1/2024
603048/GMP/2021 CCImpact Chemicals LimitedKC Arora Complex, Off Mombasa Road - KenyaKenya2/19/2021RT1376804/1/20214/1/2024Non-Beta Lactam (Vet)Non-Beta Lactam (Vet): Ectoparasiticides (Acaricides)Non-Beta Lactam (Vet): Ectoparasiticides (Acaricides)NoneDenis William Mwesigwa4/1/2024
604050/GMP/2021 CCCipla LimitedPlot Nos. L-139, S-103 & M-62 Verna Industrial Estate, Verna Salcette Goa, 403 722 - IndiaIndia3/5/2021FU20/4374/1/20214/1/2024 Unit IX: Aseptically filled, Unit IV: Non-Sterile General, Unit VII: Non-Sterile General, Unit VIII: Hormones, Unit II:, Unit III: General, Unit I: Sterile General, Unit I: Non-Sterile General Unit IX: Aseptically filled: Non-Terminally sterilized:
Large Volume Parenterals
Small Volume Parenteral Lyophilisates
Liposome Injection (Prefilled)
Terminally sterilized:
Large Volume Parenterals
Small Volume Parenterals
, Unit IV: Non-Sterile General: Capsules
Tablets
, Unit VII: Non-Sterile General: Capsules
Tablets
, Unit VIII: Hormones: Small Volume Parenterals (Aseptic)
Capsules
Creams & Topical Solutions
Tablets
, Unit II: Metered Dose Inhalers, Unit III: General: Creams/Gels/Ointment
Tablets
, Unit I: Sterile General: Respiratory Solutions
Respiratory Suspensions
Eye drops
, Unit I: Non-Sterile General: Nasal Sprays
Unit IX: Aseptically filled: Non-Terminally sterilized:
Large Volume Parenterals
Small Volume Parenteral Lyophilisates
Liposome Injection (Prefilled)
Terminally sterilized:
Large Volume Parenterals
Small Volume Parenterals
, Unit IV: Non-Sterile General: Capsules
Tablets
, Unit VII: Non-Sterile General: Capsules
Tablets
, Unit VIII: Hormones: Small Volume Parenterals (Aseptic)
Capsules
Creams & Topical Solutions
Tablets
, Unit II: Metered Dose Inhalers, Unit III: General: Creams/Gels/Ointment
Tablets
, Unit I: Sterile General: Respiratory Solutions
Respiratory Suspensions
Eye drops
, Unit I: Non-Sterile General: Nasal Sprays
NoneDenis William Mwesigwa4/1/2024
605051/GMP/2021 CCFresenius Kabi ABRapsgatan 7, 751 74 Uppsala - SwedenSweden3/10/2021RT1387734/1/20214/1/2024Non-Beta LactamNon-Beta Lactam: Large Volume Parenterals in three chamber bags
Small Volume Parenterals in Ampoules
Non-Beta Lactam: Large Volume Parenterals in three chamber bags
Small Volume Parenterals in Ampoules
NoneDenis William Mwesigwa4/1/2024
606052/GMP/2021 CCNitin Lifesciences LimitedRampur Road, Paonta Sahib, Dist. Sirmour, H.P - 173025, IndiaIndia3/10/2021RT1388304/1/20214/1/2024Non-Beta Lactam, Beta Lactam (Cephalosporin)Non-Beta Lactam: Small volume Liquid (SVP)
Ear/Eye Drops
, Beta Lactam (Cephalosporin): Dry powder for Injection (SVP)
Non-Beta Lactam: Small volume Liquid (SVP)
Ear/Eye Drops
, Beta Lactam (Cephalosporin): Dry powder for Injection (SVP)
NoneDenis William Mwesigwa4/1/2024
607053/GMP/2021 CCSquare Pharmaceuticals LimitedSquare Road, Salgaria, Pabna, 6600 - BangladeshBangladesh3/15/2021RT1389994/1/20214/1/2024Non-Beta LactamNon-Beta Lactam: Oral Liquids
Semi-solids (Creams, Ointments & Gels)
Nasal drops
Non-Beta Lactam: Oral Liquids
Semi-solids (Creams, Ointments & Gels)
Nasal drops
NoneDenis William Mwesigwa4/1/2024
608054/GMP/2021 CCVetcare Kenya Limited alias Vetcare AfricaUnit 7 and 8, Plot No. 336/202, Winsford Park Baba Dogo Road, Ruaraka, Nairobi - KenyaKenyaLicense serial No. 022, dated 15th January 2021 issued by the Veterinary Medicines Directorate9/24/2020RT1323423/29/20213/29/2024Non-Beta LactamNon-Beta Lactam: Oral Powders
Oral suspensions & Liquids
Non-Beta Lactam: Oral Powders
Oral suspensions & Liquids
NoneDenis William Mwesigwa3/29/2024
609055/GMP/2021 CCGuilin Pharmaceutical Company LimitedNo. 43, Qilidian Road, Guilin 541004, Guangxi P.R. of ChinaChina3/12/2021FU20/448, RT1389704/1/20214/1/2024Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
SVP Powders for injection
SVP Liquids (in Ampoules & vials) - Aseptically filled & terminally sterilized
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
SVP Powders for injection
SVP Liquids (in Ampoules & vials) - Aseptically filled & terminally sterilized
NoneDenis William Mwesigwa4/1/2024
610056/GMP/2021 CCFDC LimitedL-121/B, Phase III-A, Verna Industral Estate, Verna 403 722, Salcete, Goa - IndiaIndia3/18/2021RT1393434/1/20214/1/2024Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa4/1/2024
611057/GMP/2021 CCUmedica Laboratories Private LimitedPlot No. 221, G.I.D.C., 2nd Phase, Vapi, 396 195, Gujarat, IndiaIndia3/18/2021RT139351, RT1393524/1/20214/1/2024Non-Beta LactamNon-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Dry oral powders for reconstitution
SVP-Liquid Injection (Vials & Ampoules)
SVP-Dry Powders for Injection (Vials)
Non-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Dry oral powders for reconstitution
SVP-Liquid Injection (Vials & Ampoules)
SVP-Dry Powders for Injection (Vials)
NoneDenis William Mwesigwa4/1/2024
612058/GMP/2021 CCWuhan Fuxing Biological Pharmaceutical Company LimitedNo. 9 Fuxing Road Hanchuan Economic Development District, Hubei Province - ChinaChina1/12/2021RT1360094/1/20214/1/2024Non-Beta LactamNon-Beta Lactam: SVP solutions (Ampoules &Vials) Aseptically filled/filtered and terminally sterilized.
LVP solutions (Plastic & Glass bottles) Aseptically filled/filtered and terminally sterilized
Non-Beta Lactam: SVP solutions (Ampoules &Vials) Aseptically filled/filtered and terminally sterilized.
LVP solutions (Plastic & Glass bottles) Aseptically filled/filtered and terminally sterilized
NoneDenis William Mwesigwa4/1/2024
613059/GMP/2021 CC EACAizant Drug Research Solutions Private LimitedSurvey No 172/173, Apparel Park Road,
Dulapally Village, Dundigal-Gandimaisamma Mandal, Medchal-Malkhajgiri District, Hyderabad - 500100, Telangana - India
India8/16/2019RT86495 / RT115552 / RT864954/1/20214/1/2022Non-Beta LactamNon-Beta Lactam: Tablets (Coated and Uncoated)
Hard gelatin capsules
Non-Beta Lactam: Tablets (Coated and Uncoated)
Hard gelatin capsules
NoneDenis William Mwesigwa4/1/2022
614060/GMP/2021 CC EACBiodeal Laboratories LimitedPlot No. 123, Lunga Lunga Road, Industrial Area P.O. Box 32040-00600, Nairobi - KenyaKenya9/4/2019RT116198 / RT1161994/1/20214/1/2022Non-Beta LactamNon-Beta Lactam: Oral Liquids for internal use
Tablets
Hard Gelatin Capsules
Ointments, Creams and Gels
Non-Beta Lactam: Oral Liquids for internal use
Tablets
Hard Gelatin Capsules
Ointments, Creams and Gels
NoneDenis William Mwesigwa4/1/2022
615061/GMP/2021 CC EACAjanta Pharma LimitedPlot No. B-4/5/6, MIDC, Paithan, Aurangabad 431148, Maharashtra State - IndiaIndia12/11/2018RT1042284/1/20214/1/2022Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Dry powders for oral suspension
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
Dry powders for oral suspension
NoneDenis William Mwesigwa4/1/2022
616062/GMP/2021 CC EACSerum Institute of India Pvt. Limited (SIIPL)Plot No. 212/2 Hadapsar, Off Soli Poonawalla Road, Pune 411028 - IndiaIndia2/6/2020RT1226714/1/20214/1/2022Biologicals
(Vaccines)
Biologicals
(Vaccines): Lyophilized Powder for Injections
Small volume liquids for Injection
Biologicals
(Vaccines): Lyophilized Powder for Injections
Small volume liquids for Injection
NoneDenis William Mwesigwa4/1/2022
617063/GMP/2021 CC EACLaboratory & Allied LimitedPlot No. 209/ 10349, Opp. Sameer Business Park, Next to Libra House, Mombasa Road- Nairobi - KenyaKenya5/19/2020RT1265854/1/20214/1/2022Beta Lactam (Penicillin), Non-Beta LactamBeta Lactam (Penicillin): Tablets
Oral Dry Powder
Hard Gelatin Capsules
, Non-Beta Lactam: Oral Liquids
Tablets
Hard Gelatin Capsules
Ointments, Creams and Gels
Oral Dry Powder
Beta Lactam (Penicillin): Tablets
Oral Dry Powder
Hard Gelatin Capsules
, Non-Beta Lactam: Oral Liquids
Tablets
Hard Gelatin Capsules
Ointments, Creams and Gels
Oral Dry Powder
NoneDenis William Mwesigwa4/1/2022
618064/GMP/2021 CCOncotec Pharma Produktion GmbHAm Pharmapark 1, 06861 Dessau-RoBlau - GermanyGermanyDE_ST_01_MIA_2020_000512/3/2019RT119770, RT1197694/1/20214/1/2024CytotoxicCytotoxic: Small Volume Liquids (Aseptically prepared)
Large Volume Liquids (Aseptically prepared)
Lyophilisates (Aseptically prepared)
Cytotoxic: Small Volume Liquids (Aseptically prepared)
Large Volume Liquids (Aseptically prepared)
Lyophilisates (Aseptically prepared)
NoneDenis William Mwesigwa4/1/2024
619065/GMP/2021 CCFarmea10 rue Bouche Thomas, ZAC d'Orgemont, 49007 Angers Cedex 01 - FranceFrance2019/HPF/FR/20199/10/2020RT1315214/1/20214/1/2024Non-Beta LactamNon-Beta Lactam: Liquids for external use
Oral granules
Non-Beta Lactam: Liquids for external use
Oral granules
NoneDenis William Mwesigwa4/1/2024
620066/GMP/2021 CCAstraZeneca UK Operations MacclesfieldSilk Road Business Park, Macclesfield, Cheshire SK10 2SU – United KingdomUnited KingdomMIA 1790112/11/2020RT1350094/1/20214/1/2024Hormones, Non-Beta LactamHormones: Implants (Aseptically prepared), Non-Beta Lactam: TabletsHormones: Implants (Aseptically prepared), Non-Beta Lactam: TabletsNoneDenis William Mwesigwa4/1/2024
621067/GMP/2021 CCGlaxoSmithKline Australia Pty Limited1061 Mountain Highway, Boronia 3155, Victoria AustraliaAustraliaMI-15082005-LI-000773-211/18/2016RT761664/1/20214/1/2024Ritavirus VaccineRitavirus Vaccine: Large Volume Liquids (Aseptically prepared)Ritavirus Vaccine: Large Volume Liquids (Aseptically prepared)NoneDenis William Mwesigwa4/1/2024
622068/GMP/2021 CCFareva Amboise (Formerly Pfizer PGM Amboise)Zone Industrielle 29 Route des Industries 37530 Poce sur cisse - FranceFranceHPF/FR/201/20136/5/2017RT834444/1/20214/1/2024Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Small Volume Parenterals
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
Small Volume Parenterals
NoneDenis William Mwesigwa4/1/2024
623069/GMP/2021 CCA. Menarini Manufacturing Logistics and Services S.r.lVia Sette Santi, 3 50131, Florence - ItalyItalyAm-72/20171/3/2020RT1207714/1/20214/1/2024Aseptically prepared, Terminally sterilised, Non-Beta Lactam, Human/Animal ExtractsAseptically prepared: Small Volume Liquids, Terminally sterilised: Small Volume Liquids, Non-Beta Lactam: Semi-solids, Human/Animal Extracts: Small Volume LiquidsAseptically prepared: Small Volume Liquids, Terminally sterilised: Small Volume Liquids, Non-Beta Lactam: Semi-solids, Human/Animal Extracts: Small Volume LiquidsNoneDenis William Mwesigwa4/1/2024
624070/GMP/2021 CCSanofi S.p.A. ScoppitoStrada Statale 17km, 22 1-670019 Scoppito - ItalyItalyAm-53/2018 dated 04/24/20185/13/2020FU19/5294/1/20214/1/2024Hormones, Non-Beta LactamHormones: Tablets, Non-Beta Lactam: TabletsHormones: Tablets, Non-Beta Lactam: TabletsNoneDenis William Mwesigwa4/1/2024
625071/GMP/2021 CCN.V OrganonMolenstraat 110, 5342 CC OSS - NetherlandsThe Netherlands108984 F9/21/2018RT1014434/1/20214/1/2024HormonesHormones: Tablets
Implants (Aseptically prepared)
Hormones: Tablets
Implants (Aseptically prepared)
NoneDenis William Mwesigwa4/1/2024
626072/GMP/2021 CCMenarini - Von Heyden GmbHLeipziger StraBe 7-13, 01097 Dresden - GermanyGermanyDE_SN_01_MIA_2021_000412/17/2019RT1203844/1/20214/1/2024Non-Beta Lactam (Primary packaging & Quality Control testing), Non-Beta Lactam (Manufacturing of Finished Pharmaceutical Products)Non-Beta Lactam (Primary packaging & Quality Control testing): Capsules, hard shell
Capsules, soft shell
, Non-Beta Lactam (Manufacturing of Finished Pharmaceutical Products): Powders/granules
Tablets
Non-Beta Lactam (Primary packaging & Quality Control testing): Capsules, hard shell
Capsules, soft shell
, Non-Beta Lactam (Manufacturing of Finished Pharmaceutical Products): Powders/granules
Tablets
NoneDenis William Mwesigwa4/1/2024
627073/GMP/2021 CCOctapharma ABLars Forsells gata 23, 11275 Stockholm - SwedenSweden5.9.1-2020-0038732/26/2019RT1073694/1/20214/1/2024Blood productsBlood products: Large Volume Liquids (Aseptically prepared)
Small Volume Liquids (Aseptically prepared)
Blood products: Large Volume Liquids (Aseptically prepared)
Small Volume Liquids (Aseptically prepared)
NoneDenis William Mwesigwa4/1/2024
628074/GMP/2021 CCLaboratorio Aldo-Union, S.LCalle Baronesa de Malda 73, 08950 Esplugues de Llobregat (Barcelona) - SpainSpain147/30/2020RT1300984/1/20214/1/2024Non-Beta LactamNon-Beta Lactam: Tablets
Liquids for internal use
Pressurized Liquids / Solution preparations
Pressurized powder preparations
Semi-solids (Creams, Ointments, Lotions & Gels)
Nasal sprays
Non-Beta Lactam: Tablets
Liquids for internal use
Pressurized Liquids / Solution preparations
Pressurized powder preparations
Semi-solids (Creams, Ointments, Lotions & Gels)
Nasal sprays
NoneDenis William Mwesigwa4/1/2024
629075/GMP/2021 CCLaboratorios Menarini, SAAlfonso XII, 587, 08918-Badalona (Barcelona) - SpainSpain0307 dated 26/11/20199/18/2020RT1321134/1/20214/1/2024Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa4/1/2024
630076/GMP/2021 CCGP Grenzach Produktions GmbHEmil-Barell-StraBe 7 79639 Grenzach-Wyhlen - GermanyGermanyDE_BW_01_MIA_2019_0048/DE_BW_01_GP_(Bayer)2/1/2021RT1366494/1/20214/1/2024Non-Beta LactamNon-Beta Lactam: Semi-solids (Creams)Non-Beta Lactam: Semi-solids (Creams)NoneDenis William Mwesigwa4/1/2024
631077/GMP/2021 CCSmithKline Beecham LimitedClarendon Road, Worthing, West Sussex, BN14 8QH - United KingdomUnited KingdomUK_MIA_105927/22/2020RT1297394/1/20214/1/2024PenicillinPenicillin: Tablets
Powders for oral suspension
Penicillin: Tablets
Powders for oral suspension
NoneDenis William Mwesigwa4/1/2024
632078/GMP/2021 CCCelltrion Pharm, Inc.82, 2 Sandan-RO, Ochang-EUP, Cheongwon-GU, Cheongju-SI – South KoreaSouth Korea15346/26/2019RT1122704/1/20214/1/2024Non-Beta LactamNon-Beta Lactam: Capsules, hard shell
Tablets
Non-Beta Lactam: Capsules, hard shell
Tablets
NoneDenis William Mwesigwa4/1/2024
633080/GMP/2021 CCBiological E. Limited, Hyderabad, IndiaPlot No. 1, Biotech Park, Phase-II, Kolthur Village, Shameerpet Mandal, Medchal-Malkajgiri District, Telengana State, 500078 - IndiaIndia3/31/2021RT139863, RT1398654/1/20214/1/2024Vaccines and BiologicsVaccines and Biologics: Small Volume Parenteral liquids packed in vials
Small Volume Parenterals (Lyophilized) packed in vials
Small Volume Parenteral Liquids packed in pre-filled syringes
Vaccines and Biologics: Small Volume Parenteral liquids packed in vials
Small Volume Parenterals (Lyophilized) packed in vials
Small Volume Parenteral Liquids packed in pre-filled syringes
NoneDenis William Mwesigwa4/1/2024
634081/GMP/2021 CCPfizer Manufacturing Belgium NV.Rijksweg 12, 2870 Puurs - BelgiumBelgium10006546293/24/2021RT1394794/13/20214/13/2024Non-Beta Lactam, VaccinesNon-Beta Lactam: Capsules, hard shell
Tablets
, Vaccines: Lyophilisates (Aseptically prepared)
Small Volume Liquids (Aseptically prepared)
Non-Beta Lactam: Capsules, hard shell
Tablets
, Vaccines: Lyophilisates (Aseptically prepared)
Small Volume Liquids (Aseptically prepared)
NoneDenis William Mwesigwa4/13/2024
635082/GMP/2021 CCHealthcare Pharmaceutical LimitedGazariapara, Rajendrapur, Gazipur 1703 - BangladeshBangladesh4/8/2021RT138188, RT138189, RT140025, RT1400264/16/20214/16/2024Non-Beta Lactam, CephalosporinNon-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Small Volume Parenteral Liquids (Packed in glass Ampoules & Vials)
, Cephalosporin: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Powders for Oral Suspension
Non-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Small Volume Parenteral Liquids (Packed in glass Ampoules & Vials)
, Cephalosporin: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Powders for Oral Suspension
NoneDenis William Mwesigwa4/16/2024
636084/GMP/2021 CCPharmatec Pakistan (Pvt.) LimitedD-86/A, S.I.T.E., Karachi - 75700, PakistanPakistan4/7/2021RT1399714/16/20214/16/2024Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Oral Liquids
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
Oral Liquids
NoneDenis William Mwesigwa4/16/2024
637085/GMP/2021 CCCosmos LimitedRangwe Road, Off Lunga Lunga Road, Industrial Area, P.O. Box 41433 GPO, 00100 - Nairobi, KenyaKenya4/19/2021RT1403044/23/20214/23/2024Non-Beta Lactam (Human), Non-Beta Lactam (Vet)Non-Beta Lactam (Human): Tablets (Coated & Uncoated)
Hard gelatin capsules
Oral Powder Sachet (ORS)
Oral Powder in bottles
Oral Liquids
, Non-Beta Lactam (Vet): Tablets (Coated & Uncoated)
Oral Liquids
Oral Powder Sachet
Non-Beta Lactam (Human): Tablets (Coated & Uncoated)
Hard gelatin capsules
Oral Powder Sachet (ORS)
Oral Powder in bottles
Oral Liquids
, Non-Beta Lactam (Vet): Tablets (Coated & Uncoated)
Oral Liquids
Oral Powder Sachet
NoneDenis William Mwesigwa4/23/2024
638086/GMP/2021 CCOctapharma Produktionsgesellschaft Deutschland mbHWolfgang-Marguerre-Allee 1, DE-31832 Springe - GermanyGermany4/19/2021RT1403524/23/20214/23/2024Blood ProductsBlood Products: Large Volume Parenterals (Liquids) - Intermediate Albumin solutions in vialsBlood Products: Large Volume Parenterals (Liquids) - Intermediate Albumin solutions in vialsNoneDenis William Mwesigwa4/23/2024
639087/GMP/2021 CCEBEWE Pharma Ges.m.b.H. Nfg.KGMondseestraBe 11 4866 Unterach am Attersee - AustriaAustria48002011/18/2019FU19/288, JV18/3524/23/20214/23/2024Cytotoxic productsCytotoxic products: Small Volume Liquids (Terminally sterilized)Cytotoxic products: Small Volume Liquids (Terminally sterilized)NoneDenis William Mwesigwa4/23/2024
640088/GMP/2021 CCNanjing Baijingyu Pharmaceutical Company LimitedNo. 1 Huizhong Road, Nanjing Economic & Technical Development Zone, Nanjing - People's Republic of ChinaChina4/21/2021RT1403664/23/20214/23/2024Non-Beta Lactam, CytotoxicNon-Beta Lactam: Tablets (Coated and Uncoated), Cytotoxic: Tablets (Coated and Uncoated)Non-Beta Lactam: Tablets (Coated and Uncoated), Cytotoxic: Tablets (Coated and Uncoated)NoneDenis William Mwesigwa4/23/2024
641089/GMP/2021 CCNorth China Pharmaceutical Company LimitedNo. 388 Heping East Road, Shijiazhuang, Hebei - ChinaChina4/21/2021RT140407, RT1404064/23/20214/23/2024Beta Lactam (Penicillin)Beta Lactam (Penicillin): Tablets (coated and uncoated)
Hard Gelatin Capsules
Small Volume Parenteral powders
Beta Lactam (Penicillin): Tablets (coated and uncoated)
Hard Gelatin Capsules
Small Volume Parenteral powders
NoneDenis William Mwesigwa4/23/2024
642090/GMP/2021 CCBio Nova Pharmaceuticals Private LimitedC-66/1, Okhla Industrial Area, Phase-II, New Delhi 110 020 - IndiaIndia4/21/2021RT140409, RT1404105/7/20215/7/2024Non-Beta LactamNon-Beta Lactam: Tablets (Ferrous based combination)Non-Beta Lactam: Tablets (Ferrous based combination)NoneDenis William Mwesigwa5/7/2024
643091/GMP/2021 CCFaes Farma, S.A.C/ Maximo Aguirre, 14 48940 Leioa (Vizcaya) - Spain.Spain4/23/2021RT1404845/7/20215/7/2024Non-Beta LactamNon-Beta Lactam: Hard Gelatin Capsules
Liquids for internal use
Tablets (Coated and Uncoated)
Granules for oral suspension
Non-Beta Lactam: Hard Gelatin Capsules
Liquids for internal use
Tablets (Coated and Uncoated)
Granules for oral suspension
NoneDenis William Mwesigwa5/7/2024
644092/GMP/2021 CCCipla Limited Baddi (Unit-I & Unit-II).Cipla Limited, Village Upper Malpur, Post Office Bhud, Tehsil Nalagarh, District Solan, Himachal Pradesh 173205 - IndiaIndia4/26/2021RT140505, RT1405045/7/20215/7/2024Non-Beta LactamNon-Beta Lactam: Tablets (Coated and Uncoated)
Capsules (Hard gelatin)
Metered Dose Inhalers (MDI)
Non-Beta Lactam: Tablets (Coated and Uncoated)
Capsules (Hard gelatin)
Metered Dose Inhalers (MDI)
NoneDenis William Mwesigwa5/7/2024
645093/GMP/2021 CCProfarma Sh.a.St. "Myslym Keta" (ish-Antibiotik), Tirana - AlbaniaAlbania1/23/2021FU20/355, RT1362275/7/20215/7/2024Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Dry powder for oral suspension and sachets
Oral/Nasal/Ear Liquids
Galenic Suppositories, Creams and Ointments
SVP and LVP Solutions
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
Dry powder for oral suspension and sachets
Oral/Nasal/Ear Liquids
Galenic Suppositories, Creams and Ointments
SVP and LVP Solutions
NoneDenis William Mwesigwa5/7/2024
646094/GMP/2021 CCMEDMAC for Manufacturing Agricultural Chemicals & Veterinary Products LimitedAl Hussun St., 1 Km from main entrance of the Industrial City, Al Hassan Industrial City Irbid - JordanJordan1/28/2021RT136376, RT1363775/7/20215/7/2024Non-Beta LactamNon-Beta Lactam: Water Soluble Powders for Oral Solutions
Oral Liquids
Small Volume Parenteral Solutions (Secondary packaging and release)
Non-Beta Lactam: Water Soluble Powders for Oral Solutions
Oral Liquids
Small Volume Parenteral Solutions (Secondary packaging and release)
NoneDenis William Mwesigwa5/7/2024
647095/GMP/2021 CCIntas Pharmaceuticals LimitedPlot No. 423/P/A, Sarkhej Bavla Highway
Village Moraiya, Taluka - Sanand Ahmedabad - 382 213, Gujarat - India
India2/1/2021RT1366935/7/20215/7/2024Non-Beta Lactam
(Biologicals)
Non-Beta Lactam
(Biologicals): Small Volume Parenterals packed in Vials, Prefilled syringes and cartridges
Non-Beta Lactam
(Biologicals): Small Volume Parenterals packed in Vials, Prefilled syringes and cartridges
NoneDenis William Mwesigwa5/7/2024
648096/GMP/2021 CCPharma-Q (Pty) Limited50 Commando Road Industrial West Johannesburg, Gauteng 2093 - South AfricaSouth Africa2/23/2021RT1379925/7/20215/7/2024Non-Beta LactamNon-Beta Lactam: Veterinary LVP solutions aseptically filledNon-Beta Lactam: Veterinary LVP solutions aseptically filledNoneDenis William Mwesigwa5/7/2024
649097/GMP/2021 CCBayer (Pty) Limited, Crop Science Division5th Avenue, Vorsterskroon Ext 3 Nigel - South AfricaSouth Africa2/23/2021RT1379935/7/20215/7/2024Non-Beta LactamNon-Beta Lactam: Liquid EctoparasiticidesNon-Beta Lactam: Liquid EctoparasiticidesNoneDenis William Mwesigwa5/7/2024
650098/GMP/2021 CCLupin LimitedA-28/1, MIDC, Chikalthana, Aurangabad - 431210, Maharashtra - IndiaIndia3/17/2021RT139284, RT1392855/7/20215/7/2024Non-Beta LactamNon-Beta Lactam: Block 1 (rifampicin block): Tablets,
Hard Gelatin Capsules, Block 2: Tablets, Block 3: Tablets, Oral Liquid Block: Liquids for internal use (Syrups & Suspensions)
Non-Beta Lactam: Block 1 (rifampicin block): Tablets,
Hard Gelatin Capsules, Block 2: Tablets, Block 3: Tablets, Oral Liquid Block: Liquids for internal use (Syrups & Suspensions)
NoneDenis William Mwesigwa5/7/2024
651099/GMP/2021 CCMS PharmaKing Abdullah II Bin Al - Hussein Industrial Estate, Amman - JordanJordan3/18/2021RT1393235/7/20215/7/2024Non-Beta LactamNon-Beta Lactam: SVP Solutions & Lyophilizates
LVP Solutions (Bags)
Non-Beta Lactam: SVP Solutions & Lyophilizates
LVP Solutions (Bags)
NoneDenis William Mwesigwa5/7/2024
652100/GMP/2021 CCJohnson & Johnson (Pty) Limited241 Main Road, Retreat, 7945, Cape Town - South AfricaSouth Africa3/19/2021RT139398, RT1393995/7/20215/7/2024Non-Beta LactamNon-Beta Lactam: Tablets (Uncoated)
Liquids for internal use
Liquids for external use (Mouth wash)
Non-Beta Lactam: Tablets (Uncoated)
Liquids for internal use
Liquids for external use (Mouth wash)
NoneDenis William Mwesigwa5/7/2024
653101/GMP/2021 CCMicro Labs LimitedPlot No. 113 - 116, 4th Phase, KIADB, Bommasandra Industrial Area, Jigani Link Road, Anekal Taluk, Bangalore - 560099 - IndiaIndia4/15/2021RT1402355/7/20215/7/2024Non-Beta LactamNon-Beta Lactam: Ophthalmic Solutions
Small Volume Parenteral Solutions
Non-Beta Lactam: Ophthalmic Solutions
Small Volume Parenteral Solutions
NoneDenis William Mwesigwa5/7/2024
654102/GMP/2021 DRTakeda GmbH, SingenRobert-Bosch-Strasse 8, 78422 Singen - GermanyGermanyDEBW_01_MIA_2021_00213/29/2021RT139581, RT1396825/7/20215/7/2024Non-Beta LactamNon-Beta Lactam: Small Volume Parenterals – Lyophilized Powder for injectionNon-Beta Lactam: Small Volume Parenterals – Lyophilized Powder for injectionNoneDenis William Mwesigwa5/7/2024
655103/GMP/2021 DRZambon Switzerland LimitedVia Industria, 13 CH-6814 Cadempino Switzerland, P.O. Box 200Switzerland5059199/29/2020RT1271555/18/20215/18/2024Non-Beta LactamNon-Beta Lactam: Capsules, Hard Gelatin
Tablets
Non-Beta Lactam: Capsules, Hard Gelatin
Tablets
NoneDenis William Mwesigwa5/18/2024
656104/GMP/2021 CCOctapharma Dessau GmbHOtto-Reuter-Strasse 3, DE-06847 Dessau - GermanyGermany4/26/2021FU20/5095/28/20215/28/2024Blood productsBlood products: Large volume Liquids (Aseptically filled)Blood products: Large volume Liquids (Aseptically filled)NoneDenis William Mwesigwa5/28/2024
657105/GMP/2021 CCSun Pharmaceutical Industries LimitedSEZ Unit-1, Plot No. A-41, Industrial Area, Phase VIII A, S.A.S Nagar (Mohali) - 160071, Punjab - IndiaIndia4/27/2021RT140593, FU20/5155/28/20215/28/2024Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
NoneDenis William Mwesigwa5/28/2024
658106/GMP/2021 CCGlaxoSmithKline S.A.E.EL Salam City - 11491, Cairo - EgyptEgypt5/14/2021RT1413135/28/20215/28/2024Non-Beta LactamNon-Beta Lactam: Coated & Uncoated Tablets
Hard Gelatin Capsules
Oral Liquids-Solutions, Suspensions & Drops
Soft Gelatin Capsules
Non-Beta Lactam: Coated & Uncoated Tablets
Hard Gelatin Capsules
Oral Liquids-Solutions, Suspensions & Drops
Soft Gelatin Capsules
NoneDenis William Mwesigwa5/28/2024
659107/GMP/2021 CCRegal Pharmaceuticals LimitedPlot No. 7978/18, Off Baba Dogo Road, Ruaraka - KenyaKenya5/14/2021RT1413125/28/20215/28/2024Non-Beta Lactam, Beta Lactam (Penicillin)Non-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Oral Powder in bottles
Oral Liquids
Creams and Ointments, Beta Lactam (Penicillin): Tablets (Uncoated)
Hard Gelatin Capsules
Oral Powders
Non-Beta Lactam: Tablets (Coated & Uncoated)
Hard Gelatin Capsules
Oral Powder in bottles
Oral Liquids
Creams and Ointments, Beta Lactam (Penicillin): Tablets (Uncoated)
Hard Gelatin Capsules
Oral Powders
NoneDenis William Mwesigwa5/28/2024
660108/GMP/2021 CCFDC LimitedB-8, M.I.D.C., Industrial Area, Waluj, Aurangabad, 431136 - IndiaIndia5/19/2021RT1415035/28/20215/28/2024Non-Beta LactamNon-Beta Lactam: Ophthalmic solutions
Oral Liquids
Oral Rehydration salts
Non-Beta Lactam: Ophthalmic solutions
Oral Liquids
Oral Rehydration salts
NoneDenis William Mwesigwa5/28/2024
661109/GMP/2021 CCBene-Arzneimittel GmbHHertertichstr. 1-3, 81479 Munchen - GermanyGermany5/11/2021RT1412725/28/20215/28/2024Non-Beta LactamNon-Beta Lactam: Tablets (Uncoated & Coated)
Suppositories
Non-Beta Lactam: Tablets (Uncoated & Coated)
Suppositories
NoneDenis William Mwesigwa5/28/2024
662110/GMP/2021 CCBDR Pharmaceuticals International Private LimitedR.S. No. 578, Nr, Effluent Channel Road; Village - Luna, Tal-Padra; Dist - Vadodara - 391440; Gujarat - IndiaIndia5/6/2021RT141124, RT1411225/28/20215/28/2024OncologyOncology: Tablets (Coated and Uncoated) Hard Gelatin capsulesOncology: Tablets (Coated and Uncoated) Hard Gelatin capsulesNoneDenis William Mwesigwa5/28/2024
663111/GMP/2021 CCBal Pharma Limited, Unit-IVPlot No. 1, 2, 3 & 69 Sector-4, IIE, Pantnager, SIDCUL, Rudrapur Dist. Udham Singh Nagar, Uttarakhand - IndiaIndia5/21/2021RT141574, RT1415755/28/20215/28/2024Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Creams & Ointments
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
Creams & Ointments
NoneDenis William Mwesigwa5/28/2024
664112/GMP/2021 CCSteril-Gene Life Sciences Private LimitedNo. 45, Mangalam Main Road, Villianur Commune, Puducherry, 605110 - IndiaIndia5/25/2021RT1416805/28/20215/28/2024Non-Beta LactamNon-Beta Lactam: Small Volume Parenteral-Liquids InjectionsNon-Beta Lactam: Small Volume Parenteral-Liquids InjectionsNoneDenis William Mwesigwa5/28/2024
665113/GMP/2021 CCSava Healthcare LimitedPlot No. 507B-512 GIDC Estate, Wadhwan City - 363035, Dist. Surendranagar Gujarat - IndiaIndia3/18/2021RT13932, FU20/4575/28/20215/28/2024Non-Beta LactamNon-Beta Lactam: Nasal Spray
Capsules (Respicaps)
Tablets (Coated and uncoated)
Creams, ointment and gels
Dry Powder for suspensions
Non-Beta Lactam: Nasal Spray
Capsules (Respicaps)
Tablets (Coated and uncoated)
Creams, ointment and gels
Dry Powder for suspensions
NoneDenis William Mwesigwa5/28/2024
666114/GMP/2021 CCThe Arab Pesticides and Veterinary Drugs Manufacturing Company (Mobedco-Vet)Al-Hassan Industrial Estate - JordanJordan5/27/2021RT142177, RT1421765/28/20215/28/2024Non-Beta LactamNon-Beta Lactam: Water Soluble Powders for Oral Solutions
Oral Liquids
Small volume parenteral solutions
EctoParasiticides
Aerosol
Non-Beta Lactam: Water Soluble Powders for Oral Solutions
Oral Liquids
Small volume parenteral solutions
EctoParasiticides
Aerosol
NoneDenis William Mwesigwa5/28/2024
667115/GMP/2021 CCGlaxo Wellcome ProductionZone Industrielle No. 2, 23 Rue Lavoisier, 27000 Evreux FranceFrance5/28/2021RT1422095/28/20215/28/2024Non-Beta LactamNon-Beta Lactam: Pressurised preparations (Inhalers)Non-Beta Lactam: Pressurised preparations (Inhalers)NoneDenis William Mwesigwa5/28/2024