GMP Compliant Facilities as at 1st December 2021

S/NSiteSite NameAddressCountryLicense NumberPayment DateReceipt NumberInspection DateExpiration DateProduction Line CategoryLines InspectedLines PassedLines FailedGMP Team LeaderValidity of ceritificate
1010/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
2202/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
3IRF/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
4046/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
5IRF/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
6051/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
7086/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
8066/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
9IRF/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
10IRF/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
11081/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
12IRF/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
13IRF/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
14024/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
15IRF/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
16IRF/F/106/07/2019 GMP Cert No. 153/GMP/2021EgypharIndustrial Zone (A), Parts No. 9 & 10, Block 13026 – El Obour City, EgyptEgyptLicense no. 4 repeated for year 2007, code No. FM-LPM-02, serial: 000031/20146/19/2018RT972004/18/20194/18/2022Non-beta lactamNon-beta lactam: Tablets (Coated & Uncoated), Hard Gelatin Capsules, Soft gelatin capsules, Oral liquids (Syrups & Suspension), Powders for oral suspension.Non-beta lactam: Tablets (Coated & Uncoated), Hard Gelatin Capsules, Soft gelatin capsules, Oral liquids (Syrups & Suspension), Powders for oral suspension.NoneMuhammad I. Lukwago4/18/2022
17IRF/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
18020/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
19023/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
20IRF/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
21IRF/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
22080/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
23027/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
24044/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
25IRF/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
26IRF/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
27IRF/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
28IRF/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
29IRF/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
30IRF/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
31079/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
32IRF/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
33082/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
34069/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
35025/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
36IRF/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
37IRF/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
38IRF/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
39IRF/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
40IRF/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
41028/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
42IRF/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
43IRF/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
44IRF/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
45IRF/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
46IRF/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
47067/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
48068/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
49IRF/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
50IRF/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
51IRF/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
52IRF/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
53003/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
54IRF/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
55061/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
56IRF/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
57IRF/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
58IRF/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
59IRF/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
60047/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
61IRF/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
62IRF/F/029/02/2019 091/GMP/2019 Cert No.Unique Pharmaceutical LaboratoriesPlot No. 215-219 and 304-308, GIDC Industrial Estate Panoli-394116. Gujarat, IndiaIndia02/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
63IRF/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
64IRF/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
65021/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
66IRF/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
67IRF/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
68IRF/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
69076/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
70036/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
71IRF/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
72IRF/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
73IRF/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
74IRF/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
75IRF/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
76IRF/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
77IRF/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
78IRF/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
79IRF/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
80IRF/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
81IRF/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
82IRF/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
83IRF/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
84IRF/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
85IRF/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
86IRF/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
87IRF/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
88IRF/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
89IRF/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
90IRF/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
91IRF/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
92IRF/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
93IRF/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
94IRF/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
95IRF/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
96IRF/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
97IRF/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
98087/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
99088/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
100089/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
101094/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
102095/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
103096/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
104097/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
105098/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
106099/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
107105/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
108110/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
109125/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
110126/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
111132/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
112142/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
113144/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
114145/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
115IRF/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
116IRF/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
117IRF/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
118IRF/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
119IRF/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
120IRF/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
121IRF/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
122IRF/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
123IRF/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
124IRF/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
125IRF/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
126IRF/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
127IRF/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
128IRF/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
129IRF/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
130IRF/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
131IRF/F/167/12/2019 156/GMP/2021 GMP Cert No.R.N Laboratories Pvt. LimitedPlot No. 1 & 86 Diamond Park, SurSez, Sachin, Surat, IndiaIndiaG/25/1837 valid until 25/03/20195/14/2019RT110710, RT1107118/27/20198/27/2022Non-beta lactamNon-beta lactam: Liquids for External UseNon-beta lactam: Liquids for External UseNoneZaidi Mwondha8/27/2022
132IRF/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
133IRF/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
134IRF/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
135IRF/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
136IRF/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
137IRF/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
138158/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
139159/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
140160/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
141161/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
142162/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
143163/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
144164/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
145167/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
146001/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
147IRF/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
148IRF/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
149IRF/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
150IRF/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
151IRF/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
152IRF/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
153IRF/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
154IRF/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
155IRF/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
156IRF/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
157IRF/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
158IRF/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
159IRF/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
160IRF/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
161IRF/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
162IRF/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
163IRF/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
164IRF/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
165IRF/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
166IRF/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
167IRF/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
168IRF/F/035/02/2020 GMP Cert No. 118/GMP/2021Baroque Pharmaceuticals Private LimitedPlot No. 192/2 & 3, 190/1 and 202/9, Sokhada - 388620, Tal.: Khambhat, Dist; Anand, Gujarat State - 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
169IRF/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
170IRF/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
171IRF/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
172IRF/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
173IRF/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
174IRF/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
175IRF/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
176IRF/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
177IRF/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
178IRF/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
179IRF/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
180IRF/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
181IRF/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
182IRF/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
183IRF/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
184IRF/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
185IRF/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
186IRF/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
187IRF/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
188IRF/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
189IRF/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
190005/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
191013/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
192020/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
193021/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
194026/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
195027/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
196028/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
197029/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
198034/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
199IRF/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
200IRF/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
201044/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
202058/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
203IRF/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
204IRF/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
205IRF/F/071/06/2020 GMP Cert No. 117/GMP/2021Emcure Pharmaceuticals Pvt. LimitedPlot No. P-1 and P-2 ITBT Park, Phase II, MIDC, Hinjawadi:, 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), OncologyGeneral (Non Beta Lactam): Tablets
Hard Gelatin Capsules
SVP Liquids (Injections)
, Oncology: SVP Injections
General (Non Beta Lactam): Tablets
Hard Gelatin Capsules
SVP Liquids (Injections)
, Oncology: SVP Injections
NoneAnnet Ssekindu11/8/2022
206063/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
207064/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
208069/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
209070/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
210071/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
211IRF/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
212IRF/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
213IRF/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
214075/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
215083/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
216084/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
217085/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
218086/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
219087/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
220088/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
221089/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
222IRF/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
223IRF/F/076/08/2020 GMP Cert No. 173/GMP/2021PT. Caprifarmindo Laboratories Pharmaceutical PlantJalan Industri Cimareme No. 8 Desa Cimareme, Kecamatan Padalarang, Kabupaten Bandung Barat 40553 - IndonesiaIndonesiaCertificate No. HK.07.IF/V/254/14 (Open validity)9/10/2018RT1012092/28/20202/28/2023Non-Beta LactamNon-Beta Lactam: Tablets, Liquids for internal use Non-Beta Lactam: Tablets, Liquids for internal use NoneWilberforce Kwiringira2/28/2023
224IRF/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
225092/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
226093/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
227094/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
228095/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
229098/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
230IRF/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
231102/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
232103/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
233104/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
234105/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
235106/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
236110/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
237111/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
238112/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
239113/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
240114/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
241115/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
242116/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
243117/GMP/2020 CCSandoz Grup Saglik Urunleri llaclari Sanayi ve Ticaret A.S.Organize Sanayi Bolgesi, Ihsan Dede Caddesi 900. Sokak 41400 Gebze Kocaeli - TurkeyTurkey2/28/2019JV10/7649/28/20209/28/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneDenis William Mwesigwa9/28/2023
244118/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
245119/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
246121/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
247122/GMP/2020 CCAgog Pharma LimitedPlot No. 33, Sector II, The Vasai Taluka Indl. Co-op. Estate Limited, Gauraipada, Vasai (E). Dist. Thane 401 208,