GMP Compliant Facilities as at September 2020

S/NSiteSite NameAddressCountryInspection DateExpiration DateProduction Line CategoryLines InspectedLines PassedLines FailedAverage ScoreAudit StatusGMP Team Leader
1142/GMP/2018 DRA. Menarini Manufacturing Logistics and Services S.R.LVia Campo di Pile- 67100 L’aquila (AQ) ItalyItaly06/08/201806/08/2021Non Beta LactamTablets (Coated and Uncoated)Tablets (Coated and Uncoated)NoneCompliantDenis Mwesigwa
2010/GMP/2019 DRA. Nattermann and Cie. GmbHNattermannallee 1, 50829 Koln, GermanyGermany08/01/201908/01/2022Non-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 LiquidsNoneCompliantKaleebu Frank
3IRF/F/030/02/2019 084/GMP/2019 GMP Cert No.Abaris Healthcare Pvt LimitedPlot no: 1407/11, Village: rajpur, Taluka: kadi, dist.: mehsana -382 740, Gujarat, indiaIndia30/11/2018Non-beta Lactam Blow-Fill-Seal (BFS)Non-beta Lactam Blow-Fill-Seal (BFS): • Large Volume Parenteral Solutions (BFS) terminally sterilized • Small volume parenteral solutions 100ml (BFS) terminally sterilizedNon-beta Lactam Blow-Fill-Seal (BFS): • Large Volume Parenteral Solutions (BFS) terminally sterilized • Small volume parenteral solutions 100ml (BFS) terminally sterilizedNone14th February 2019 Report DateCompliantMwonda Zaid
4IRF/F/051/03/2019 GMP Cert No. 062/GMP/2019Abbott Biologicals B.V.Veerweg 12, 8121 AA Olst, The Netherlands.Netherlands30/11/2018Non-Beta LactamNon-Beta Lactam: • Influenza virus vaccine in pre-filled syringes • Hormonal tablets, coated • Oral liquidsNon-Beta Lactam: • Influenza virus vaccine in pre-filled syringes • Hormonal tablets, coated • Oral liquidsNone21st March 2019 Report dateCompliantSsali Peter
5IRF/F/320/06/2018 R10 097/GMP/2018Abbott Laboratories,Justus- Von- Liebig- Str. 33 31535 Neustadt A.RBGE., GermanyGermany26/04/201826/04/2021BiologicalsBiologicals Pancreatin(API) Finished Products- Creon/Kreon capsule bulk/intermediate,blister and bottle packsPancreatin(API) Finished Products- Creon/Kreon capsule bulk/intermediate,blister and bottle packsNone18th June 2018 Report DateCompliantOnen Solomon L.
6IRF/F/346/07/2018 R11 038/GMP/2019 GMP Cert No.Aburaihan Pharmaceutical Co.No. 1 Tirandaz Ave. Tehranpars, Tehran, P.O. Box 16765/1568 Aburaihan, IranIran14/05/2018Non Beta-lactam: (a) Hormones: (b) Non-Hormones:Non Beta-lactam: (a) Hormones: • Tablets • Small Volume Parenteral Injection Liquids (b) Non-Hormones: • Tablets • Small Volume Parenteral Injection Liquids • Hard Gelatin Capsules • Suppositories • Creams, ointments, gels and lotionsNon Beta-lactam: (a) Hormones: • Tablets • Small Volume Parenteral Injection Liquids (b) Non-Hormones: • Tablets • Small Volume Parenteral Injection Liquids • Hard Gelatin Capsules • Suppositories • Creams, ointments, gels and lotionsNoneCompliantEtuko Daniel
7IRF/F/122/11/2017-R5 042/GMP/2018Adwia SAE10th Ramadhan City Industrial Area-A2 EgyptEgypt08/10/201708/10/2020NBL (Human and Vet)Human (NBL)- Tablets, Oral powder for suspension, SVP-Solutions in Ampoules Vet(NBL)- SVP-Solutions in Vials, Oral powder for suspensionHuman (NBL)- Tablets, Oral powder for suspension, SVP-Solutions in Ampoules Vet(NBL)- SVP-Solutions in Vials, Oral powder for suspensionNone15/02/2018 CAPA submittedCompliantNasser Lubowa
8202/GMP/2018Aeropharm GmbHFrancois – Mitterand – Allee 1, 07407 Rudolstadt, GermanyGermany13/12/2018Non-Beta LactamNon-Beta Lactam Pressurised Preparations (Metered Dose Inhalers)Non-Beta Lactam Pressurised Preparations (Metered Dose Inhalers)NoneCompliantKaleebu Frank
9068/GMP/2018 DRAesica QueenBorough LimitedNorth Road, Queenborough, Kent ME 11 5EL United KingdomUnited Kingdom14/05/201814/05/2021Non Beta LactamLiquids For Internal Use (Inhalation Anaesthetics)Liquids For Internal Use (Inhalation Anaesthetics)None14th May 2018 Report DateCompliantDenis Mwesigwa
10IRF/F/388/09/2018 R12 178/GMP/2018 GMP Cert NoAfricure Pharmaceuticals India Pvt. LimitedPlot No 9 – 12, Dewan & Sons Industrial Area, Veoor, Palghar – 401404 Palghar District Maharashtra State, IndiaIndia27/07/201827/07/2021Non Beta LactamNon Beta Lactam • Tablets (coated and uncoated) • Hard Gelatin CapsulesNon Beta Lactam • Tablets (coated and uncoated) • Hard Gelatin CapsulesNone15/11/2018 CAPA SUBMITTEDCompliantNasser Lubowa
11IRF/F/180/01/2018- R8 054/GMP/2018Agio Pharmaceuticals Ltd.T – 81,82, M.I.D.C., Bhosari, Pune – 411 026, Maharashtra State- IndiaIndia12/12/201712/12/2020Non-beta lactamNon-beta lactam SVP solutions Cream/ ointment/ Gel Tablets Oral liquid formulations Hard gelatin Capsule formulation line Oral dry powders packed in sachetNon-beta lactam SVP solutions Cream/ ointment/ Gel Tablets Oral liquid formulations Hard gelatin Capsule formulation line Oral dry powders packed in sachetNone29/03/2018 CAPA SUBMITTEDCompliantDennis Mwesigwa
12IRF/F/152/12/2017- R6 082/GMP/2018Agog Pharma Ltd.Plot No. 33, Sector II, The Vasai Taluka Indl. Co-op. Estate Ltd., Gauraipada, Vasai (E). Dist. Thane-401 208, INDIA.India20/10/201720/10/2020Non-beta lactam• Tablets • Hard Gelatin capsules • Creams, Lotions & Ointments • Oral rehydration salts • Powders for oral suspension • Oral liquids• Tablets • Hard Gelatin capsules • Creams, Lotions & Ointments • Oral rehydration salts • Powders for oral suspension • Oral liquidsNone 10th December 2017 REPORT DATE06/04/2018 CAPA SubmittedCompliantOnen Solomon L.
13IRF/F/073/05/2019 182/GMP/2019 Cert No.Ajanta Pharma LimitedPlot No.Z/103/A,Dahej SEZ Part II,District: Bharuch, Gujarat-392130, IndiaIndia25/01/201925/01/2022Non ?-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 jellyNone10th May 2019 GMP Report DateCompliantWilberforce Kwiringira
14IRF/F/421/10/2018 001/GMP/2019 GMP Cert No.Ajanta Pharma Limited (Chikalthana Unit)31-O, MIDC Area, Chikalthana, Aurangabad-431210, Dist: Aurangabad, Maharashtra state.India13/09/201813/09/2021Non beta lactamNon beta lactam: • Oral liquidsNon beta lactam: • Oral liquidsNone04/12/2018 CAPA SUBMITTEDCompliantAtumanya Amos
15171/GMP/2017 - DRAjanta Pharma LtdPlot No. Z/103/A, Dahej SEZ Part II, District Bharuch, Gujarat 392130India08/11/201708/11/2020NBL- Hard Gelatin Capsules - Oral jelly - Powders for oral suspension - Oral liquids - SVP - TabletsTablets- Hard Gelatin Capsules - Oral jelly - Powders for oral suspension - Oral liquids - SVPCompliantMwesigwa Denis
16IRF/F/192/01/2018- R8 041/GMP/2018Akums drugs & pharmaceuticals LtdPlant 4, 47-48 sector 6A, IIE SIDCUL, Ranipur, Haridwar, 249403, Uttrakhand, India.India12/12/201712/12/2020Non-Beta lactam (Hormonal products)Non-Beta lactam (Hormonal products) Tablets Hard gelatin capsules Soft gelatin capsules Small volume parenteral (ampoules /Vials) Gels /Ointments /CreamsNon-Beta lactam (Hormonal products) Tablets Hard gelatin capsules Soft gelatin capsules Small volume parenteral (ampoules /Vials) Gels /Ointments /CreamsNone20/03/2018 CAPA SUBMITTEDCompliantMutyaba Michael
17IRF/F/352/08/2018 R12 040/GMP/2019 GMP Cert No.Akums Drugs and Pharmaceuticals LtdPlant 111(Injectable facility) Plot No: 2, 3, 4 & 5 sector 6B, 11E, SIDCUL. Ranipur District Haridwar (Uttarakhand) India.India22/06/2018Non-beta lactam Beta lactamNon-beta lactam • SVP solutions (packed in glass ampoules and vials) • SVP solutions as eye and ear drops (FFS) • LVP solutions (BFS) Beta lactam • SVP powders in glass vials (penicillin) • SVP powders in glass vials (Cephalosporin)Non-beta lactam • SVP solutions (packed in glass ampoules and vials) • SVP solutions as eye and ear drops (FFS) • LVP solutions (BFS) Beta lactam • SVP powders in glass vials (penicillin) • SVP powders in glass vials (Cephalosporin)None10/10/2018 CAPA SUBMITTEDCompliantLukwago Mohammad
18IRF/F/349/07/2018 R11 016/GMP/2019 GMP Cert No.Alborz Darou Pharmaceutical Company8th Hekmat St. Alborz Industrial City Qazvin 34319 57691-IranIran23/05/201823/05/2021Non Beta LactamNon Beta Lactam; • Small Volume Parenteral Injection liquids (in ampoules) • Small Volume Parenteral Injection liquids (in prefilled syringes) • Oral liquids • Capsules • TabletsNon Beta Lactam; • Small Volume Parenteral Injection liquids (in ampoules) • Small Volume Parenteral Injection liquids (in prefilled syringes) • Oral liquids • Capsules • TabletsNoneCAPA SubmittedCompliantEtuko Daniel
19066/GMP/2018 DRAlcon Cusi S.A ( Barcelona, Spain)Alcon Cusi S.A, Camil Fabra, 58, 08320EI, Masnou, Barcelona, SpainSpain05/05/201805/05/2021Non Beta LactamSterile Eye Ointments Sterile Eye Drops Non Sterile Ear DropsSterile Eye Ointments Sterile Eye Drops Non Sterile Ear DropsNone05th May 2018 Report DateCompliantDenis Mwesigwa
20IRF/F/392/09/2018 R12 180/GMP/2018 GMP Cert NoAlivira Animal Health LtdA-68, MIDC Industrial Area, Additional Ambernath; Thane, Maharashtra-IndiaIndia14/08/201814/08/2021Non Beta Lactam (veterinary use)Non Beta Lactam (veterinary use) • SVP (Granules for injection) • Liquids (Oral suspensions)Non Beta Lactam (veterinary use) • SVP (Granules for injection) • Liquids (Oral suspensions)None03/12/2018 CAPA SUBMITTEDCompliantMwesigwa Denis
21IRF/F/133/11/2017- R6 025/GMP/2018Alkem Laboratories LimitedPlot no. 333/1, Silicon Industrial Estate, At & Post-Kachigam, Daman-396 210 (U.T)India10/10/201710/10/2020Non-beta lactam• Tablets (coated) • Capsules (hard gelatin) • Powders for oral solution• Tablets (coated) • Capsules (hard gelatin) • Powders for oral solutionNone22/02/2018 CAPA SubmittedCompliantMuhammad I. Lukwago
22IRF/F/391/09/2018 R12 078/GMP/2019 GMP Cert No.Alkem Laboratories LtdVillage-Thana, Baddi, Tehsil-Nalagarh Solan ,Himachal Pradesh-173205India29/06/201829/06/2021Beta Lactam (Penicillin)Beta Lactam (Penicillin): Tablets (coated & uncoated) Capsules (hard gelatin) Powders for oral solution Small Volume Parenteral PowdersBeta Lactam (Penicillin): Tablets (coated & uncoated) Capsules (hard gelatin) Powders for oral solution Small Volume Parenteral PowdersNone16/11/2018 CAPA SUBMITTEDCompliantMuhammad I. Lukwago
23046/GMP/2019 DRAndersonBrecon (UK) LimitedUnits 2-7, Wye Valley Business Park,Brecon Road, Hay-on-Wye, Hereford, HR3 5PG, United Kingdom.United Kingdom20/02/201920/02/2022Non-Beta LactamNon-Beta Lactam: Primary and Secondary PackagingNon-Beta Lactam: Primary and Secondary PackagingNoneCompliant
24IRF/F/359/08/2018 R12 189/GMP/2018 GM Cert NoArab Drug Company for pharmaceuticals & chemical industries5 EL Massanei Street AL Amireya – Cairo- EgyptEgypt12/07/201812/07/2021Non ?-lactamNon ?-lactam • Aerosol InhalerNon ?-lactam • Aerosol InhalerNone16/11/2018 CAPA SUBMITTEDCompliantKenneth Kiiza
25IRF/F/083/05/2019 172/GMP/2019 Cert No.Arab Veterinary Industrial Company AvicoAlquds St- Naur, Amman Jordan, P.O Box 150906Jordan16/04/201916/04/2022Non-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 SuspensionsNone29th May 2019 Report DateCompliantKaleebu Frank
26IRF/F/158/01/2018- R6 050/GMP/2018Aristo Pharmaceuticals Pvt LtdVillage Makhnumajra, P.O Bhud Tehsil: Baddi, Distt. Solan Himachal Pradesh-173205, INDIA.India07/10/201707/10/2020Non-beta lactam Beta lactam(Cephalosporin)Non-beta lactam; • Tablets (coated and uncoated) • Hard Gelatin capsules. Beta lactam(Cephalosporin) • Tablets (coated and uncoated) • Oral dry powder for suspension • Small volume parenteral (powders)Non-beta lactam; • Tablets (coated and uncoated) • Hard Gelatin capsules. Beta lactam(Cephalosporin) • Tablets (coated and uncoated) • Oral dry powder for suspension • Small volume parenteral (powders)None15/03/2018 CAPA SubmittedCompliantOnen Solomon L.
27IRF/F/135/11/2017- R6 049/GMP/2018Artura Pharmaceuticals Pvt LtdPlot No. 1505 Portia Road, Sri City Sez, Satyavedu Mandal, Chittor District. Andhra Pradesh-517 588India10/10/201710/10/2020Non-beta lactam• Tablets (coated and uncoated) • Capsules (hard gelatin)• Tablets (coated and uncoated) • Capsules (hard gelatin)None29/12/2017 CAPA SUBMITTEDCompliantKeneth Kiiza
28IRF/F/339/07/2018 R11 121/GMP/2018Aryogen Pharmed Co.No. 140, Tajbakhsh Street, 24th Kilometer Tehran-Karaj Makhsous Road, Alborz, Iran.Iran30/05/201830/05/2021Biological products (Recombinant technology Oncology & Non Oncology products)Biological products (Recombinant technology Oncology & Non Oncology products) • SVP Liquids (Packed In Vials and Prefilled syringes) • SVP Lyophilized powdersBiological products (Recombinant technology Oncology & Non Oncology products) • SVP Liquids (Packed In Vials and Prefilled syringes) • SVP Lyophilized powdersNone17th July 2018 Report DateCompliantEtuko Daniel
29IRF/F/323/06/2018 R10 172/GMP/2018Ascendis Pharmaceuticals4 Brewery Street, Isando 1609, South AfricaSouth Africa20/04/201820/04/2021Non Beta lactamNon Beta lactam • Tablets(uncoated)Non Beta lactam • Tablets(uncoated)NoneCAPA SUBMITTED 26/09/2018CompliantNambasa Victoria
30164/GMP/2018 DRAstra Zeneca Pharmaceuticals Limited587 Old Baltimore Pike Newark De 19702 United States of AmericaUnited States Of America31/10/201831/10/2021Non-Beta LactamNon-Beta Lactam TabletsNon-Beta Lactam TabletsNoneCompliantKaleebu Frank
31196/GMP/2018 DRAstraZeneca Mt Vernon Operations4601 Highway 62 East Mt Vernon IN 47620United States Of America28/11/2018Non-Beta LactamNon-Beta Lactam TabletsNon-Beta Lactam TabletsNoneCompliantKaleebu Frank
32051/GMP/2019 DRAstraZeneca Sweden OperationsAstraZeneca Sweden Operations, SE-151 85 Sodertalje Sweden.Sweden12/03/201912/03/2022Non-Beta LactamNon-Beta Lactam: Tablets SVP Lyophilisates SVP Pressurised Inhalers Nebulising SuspensionsNon-Beta Lactam: Tablets SVP Lyophilisates SVP Pressurised Inhalers Nebulising SuspensionsNoneCompliant
33IRF/F/145/11/2017- R6 022/GMP/2018Atco Laboratories LtdB-18, S.I.T.E Karachi-74700Pakistan03/10/201703/10/2020Non Beta Lactam• Semi-solids (ointments and creams) • Oral Liquids • Eye drops (Sterile)• Semi-solids (ointments and creams) • Oral Liquids • Eye drops (Sterile)None19/01/2018 CAPA SubmittedCompliantZaidi Mwondha
34086/GMP/2019 DRAthlone Pharmaceuticals LimitedBallymurray, Co. Roscommon - IrelandIreland05/06/201905/06/2022PenicillinPenicillin: Hard gelatin capsules Oral LiquidsPenicillin: Hard gelatin capsules Oral LiquidsNoneCompliantKaleebu Frank
35IRF/F/036/02/2019 042/GMP/2019 GMP Cert No.Aurobindo Pharma LimitedUnit VII (SEZ), Plot No.S1, Green Industrial Park, Polepally (V) Jedcheria (M), Mahaboob Nagar Hyderabad, 509 302 A.P IndiaIndia20/11/2018Non-beta LactamNon-beta Lactam: • Tablets ( coated and un coated) • Hard Gelatin Capsule • Soft Gelatin CapsuleNon-beta Lactam: • Tablets ( coated and un coated) • Hard Gelatin Capsule • Soft Gelatin CapsuleNone14th February 2019 Report DateCompliantAnnet Ssekindu
36IRF/F/177/01/2018- R9 118/GMP/2018Aurobindo Pharma Limited Unit 3Plot no. 313, 314, Bachupally, RR Dist. 500090 IndiaIndia14/11/201714/11/2020Non-beta lactamNon-beta lactam • Tablets (coated & uncoated) • Capsules (hard gelatin) • Oral liquids (Suspensions & syrups)Non-beta lactam • Tablets (coated & uncoated) • Capsules (hard gelatin) • Oral liquids (Suspensions & syrups)None22/01/2018 Report dateCompliantEtuko Daniel
37IRF/F/161/01/2018- R7 087/GMP/2018Aurobindo Pharma Limited, Formulations Unit-VI- R7Aurobindo Pharma Limited, Formulations Unit-VI Sy.No.329/39 & 329/47 Chitkul(V) Patancheru Mandal, Sanga Reddy Dist502307 TelanganaIndia08/12/201708/12/2020Beta lactam cephalosporin• Small Volume Parenteral powders (aseptically prepared) • Tablets • Hard Gelatine Capsules • Dry powders for oral suspensions.• Small Volume Parenteral powders (aseptically prepared) • Tablets • Hard Gelatine Capsules • Dry powders for oral suspensions.None05/01/2018 Report dateCompliantKaleebu Frank
38IRF/F/403/09/2018 R12 152/GMP/2018 GMP CERT NoAurobindo Pharma Limited, Unit-XPlot No.16, APIIC Multiproduct SEZ Telangana District- 509302 Menakuru, Naidupet Mandal, Nellore District, Pin code: 524421, Andhra Pradesh. IndiaIndia31/07/2018Non-beta lactamNon-beta lactam • Hard gelatin Capsules • Tablets • Oral liquids for human useNon-beta lactam • Hard gelatin Capsules • Tablets • Oral liquids for human useNone28th September, 2018 REPORT DATECompliantZaid Mwonda
39IRF/F/379/09/2018 R12 145/GMP/2018 GMP CERT NoAurobindo Unit XVPlot No. 17 A, E. Bonangi (Village), Jawaharlal Nehru Pharma City, Parawada Mandal, Visakhapatnam Dist, Andhra Pradesh -531021 IndiaIndia24/07/2018Non-Beta lactamNon-Beta lactam • Tablets (Uncoated, Film coated, Enteric coated) • Capsules (Hard gelatin)Non-Beta lactam • Tablets (Uncoated, Film coated, Enteric coated) • Capsules (Hard gelatin)None08th September 2018 REPORT DATECompliantEtuko Daniel
40IRF/F/176/01/2018- R8 015/GMP/2018 GMP CERTAuronext Pharma PVT LtdA-1128, Riico Industrial area, Phase-111, Bhiwadi -301019, Alwar District Rajasthan, India.India10/11/2017Carbapenems:Carbapenems: Aseptically filled SVP dry powder vials Lyophilized SVP Powders in vialsCarbapenems: Aseptically filled SVP dry powder vials Lyophilized SVP Powders in vialsNone22/01/2018 GMP Issued dateCompliantEtuko Daniel
41IRF/F/438/12/2018 165/GMP/2019 GMP CertAxa Parenterals LtdAxa Parenterals Ltd, Kishanpur Jamalpur Roorkee Dist Haridwar-247667 Uttarakhand, IndiaIndia21/09/201821/09/2021Non-Beta Lactam Blow-Fill-Seal (BFS)Non-Beta Lactam Blow-Fill-Seal (BFS): • Large Volume Parenteral Solutions • Small Volume Parenteral Solutions • Eye drops and respulesNon-Beta Lactam Blow-Fill-Seal (BFS): • Large Volume Parenteral Solutions • Small Volume Parenteral Solutions • Eye drops and respulesNone14/12/2018 Report DateCompliantSsali Peter
42066/GMP/2019 DRBalkanpharma-Dupnitsa AD3 Samokovsko Shosse Str., 2600 Dupnitsa - BulgariaBulgaria01/04/201901/04/2022Non-Beta LactamNon-Beta Lactam: Tablets Hard Gelatin CapsulesNon-Beta Lactam: Tablets Hard Gelatin CapsulesNoneCompliantOnen Solomon L.
43IRF/F/373/09/2018 R12 134/GMP/2018Bard Pharmaceuticals LimitedUnit 191, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, U.KUnited Kingdom12/06/2018Non beta-lactam.Non beta-lactam. ? Tablets (coated & uncoated) ? Hard gelatin capsules ? Granules for oral suspensionNon beta-lactam. ? Tablets (coated & uncoated) ? Hard gelatin capsules ? Granules for oral suspensionNone07th September 2018 Report DATECompliantWilberforce Kwiringira
44IRF/F/110/07/2019 GMP Cert No. 011/GMP/2020Bash Pharma Company LimitedSoba Industrial area, Khartoum- Sudan Plot No.8 Block 11-SudanSudan11/04/201911/04/2021Veterinary (Non-beta lactam) Human (Non-beta lactam)Veterinary (Non-beta lactam): Oral powders, Oral liquids, Small & Large volume parenteral liquids (aseptically prepared). Human (Non-beta lactam): Sterile eye drops (aseptically prepared)Veterinary (Non-beta lactam): Oral powders, Oral liquids, Small & Large volume parenteral liquids (aseptically prepared). Human (Non-beta lactam): Sterile eye drops (aseptically prepared)None22nd July 2019CompliantLukwago Mohammad
45IRF/F/330/05/2018 R10 GMp Cert No. 010/GMP/2020Bayer (Pty) Ltd Crop science division5th Avenue, Vorsterskroon Ext 3 Nigel. South AfricaSouth Africa07/08/201807/08/2021Non Beta-lactam• Liquid EctoparasiticidesNone Beta - Lactam: Liquid EctoparasiticidesNone17th May 2018 Report dateCompliantNambasa Victoria
46146/GMP/2018 DRBayer Healthcare Manufacturing S.R.LVia E. Schering, 21-20090 Segrate, Milano ItalyItaly17/09/201817/09/2021Non Beta LactamCreams OintmentsCreams OintmentsNoneCompliantDenis Mwesigwa
47IRF/F/385/09/2018 R12 093/GMP/2019 Cert No.Bayer Korea, Banwol plant14, Neungan-ro, Danwon-gu, Ansan-si, Gyeonggi-do, Korea 425100, Republic of South KoreaKorea, Republic of (South)10/08/201810/08/2021Non beta-lactam veterinaryNon beta-lactam veterinary • LVP solutions • SVP solutions. • Oral liquidsNon beta-lactam veterinary • LVP solutions • SVP solutions. • Oral liquidsNone13th September 2018 REPORT DATECompliantOnen Solomon L.
48079/GMP/2018 DRBayer Pharma AGBayer Pharma AG, 51368 Leverkusen, GermanyGermany30/05/201830/05/2021Non Beta LactamTablets Small Volume Parenterals Large Volume ParenteralsTablets Small Volume Parenterals Large Volume ParenteralsNone3oth May 2018 Report DateCompliantDenis Mwesigwa
49070/GMP/2018 DRBayer Pharma AG, BerlinMullerstrasse 178,13353 Berlin, GermanyGermany14/05/201814/05/2021Non Beta LactamTablets (Coated and Uncoated) Small Volume Parenterals Large Volume ParenteralsTablets (Coated and Uncoated) Small Volume Parenterals Large Volume ParenteralsNone14/05/2018 Report DateCompliantDenis Mwesigwa
50076/GMP/2018 DRBayer Weimer GmbH und Co.KGDoebereinerstrasse 20 D-99427 Weimer, Germany.Germany28/05/201828/05/2021Non Beta LactamTabletsTabletsNone28th May 2018 Report DateCompliantDenis Mwesigwa
51IRF/F/185/01/2018- R8BDR Pharmaceuticals Pvt LtdR.S.NO. 578, NR. Effluent Channel Road, Village; Luna, Tal; Padra, Dist- Vadodara-391 440; Gujarat, India.India17/11/201717/11/2020Beta-lactam (Oncology products)Beta-lactam (Oncology products) • Tablets (coated and uncoated) • Hard gelatin capsulesBeta-lactam (Oncology products) • Tablets (coated and uncoated) • Hard gelatin capsulesNone13/09/2018 Additional Information SubmittedCompliantAnnet Ssekindu
52173/GMP/2017 - DRBell, sons and Co. (Druggists) LtdGifford House, Slaidburn Crescent, Southport, PR9 9ALUnited Kingdom08/11/201708/11/2020NBLPowders for oral suspension Creams/Ointments/lotions Oral liquidsPowders for oral suspension Creams/Ointments/lotions Oral liquidsNoneCompliantMwesigwa Denis
53IRF/F/324/06/2018 R10 GMp Cert No. 031/GMP/2020Bene-Arzneimittel Gmbh,Production and Warehousing- Herterichstr. 1-3 D-81479 Munich Germany. Quality Control Laboratory - Bayerwaldstr. 7-9 D-82538 Geretsried, Germany. High-rack warehousing – Gewerbering 11 D-82140 Olching, Germany Germany13/04/201813/04/2021Non Beta lactamNon Beta lactam: • Tablets (coated & uncoated) • SuppositoriesNon Beta lactam: • Tablets (coated & uncoated) • SuppositoriesNone18th June 2018 Report DateCompliantOnen Solomon L.
54194/GMP/2018 DRBerlin-Chemi AG (Andlershof site)Glienicker Weg, 125-D-12489 BerlinGermany30/11/2018Non-Beta LactamNon-Beta Lactam Tablets (Primary and Secondary Packaging, Quality Control Testing)Non-Beta Lactam Tablets (Primary and Secondary Packaging, Quality Control Testing)NoneCompliantKaleebu Frank
55195/GMP/2018 DRBerlin-Chemi AG, Site BitzTempelhofer Weg, 83-D-12347Germany30/11/2018Non-Beta LactamNon-Beta Lactam Tablets (Bulk manufacturing)Non-Beta Lactam Tablets (Bulk manufacturing)NoneCompliantKaleebu Frank
56IRF/F/053/03/2019 075/GMP/2019 GMP Cert No.Beta Drugs LimitedKharuni-Lodhimajra, Vil. Nandpur Baddi, Dist.-Solan, Himachal Pradesh, India.India05/12/2018Non-beta lactam (Oncology)Non-beta lactam (Oncology) • Tablets (Coated and Uncoated) • Hard Gelatin Capsules • Small Volume Parenterals- Lyophilised Powders • Small Volume Parenterals-Solutions Aseptically filledNon-beta lactam (Oncology) • Tablets (Coated and Uncoated) • Hard Gelatin Capsules • Small Volume Parenterals- Lyophilised Powders • Small Volume Parenterals-Solutions Aseptically filledNone21st March 2019 Report dateCompliantNasser Lubowa
57IRF/F/146/11/2017- R6BF Biosciences Ltd5KM, Sundar Raiwand Road, Raiwind, Lahore, PakistanPakistan17/10/201717/10/2020Non Beta Lactam• SVP solutions & Lyophilizates.• SVP solutions & Lyophilizates.NoneCompliantZaidi Mwondha
58IRF/F/394/09/2018 R12 058/GMP/2019 GMP Cert No.Biocon LimitedSpecial Economic Zone Plot No. 2, 3, 4, & 5 Phase IV, Bommasandra Jigani Link Road ,Bangalore 560 099 IndiaIndia14/05/2018Non Beta LactamNon Beta Lactam • Aseptically filled SVP biological solution in vial, cartridges & pre-filled syringes. • Aseptically filled SVP biological lyophilizate in glass vials.Non Beta Lactam • Aseptically filled SVP biological solution in vial, cartridges & pre-filled syringes. • Aseptically filled SVP biological lyophilizate in glass vials.None28th September 2018 REPORT DATECompliantVictoria Kwesiga
59IRF/F/134/11/2017-R6Biological E. LimitedPlot No.1, S.P. Biotechnology Park, Phase II, Kolthur Village, Shameerpet Mandal, Ranga Reddy District - 500078, Telangana State, India.India06/10/201706/10/2020Vaccines And Biological Products• Small Volume Parenteral liquids packed in vials • Small Volume Parenterals (lyophilized) packed in vials • Small volume parenteral liquids packed in pre-filled syringes• Small Volume Parenteral liquids packed in vials • Small Volume Parenterals (lyophilized) packed in vials • Small volume parenteral liquids packed in pre-filled syringesNoneCompliantMuhammad I. Lukwago
60IRF/F/435/12/2018 197/GMP/2018 GMP Cert No.Bioton S.ABioton S.A Macierzysz, Poznanska12 str 05-850 Ozarow Mazowiecki PolandPoland20/10/2018Non-beta lactamNon-beta lactam: • Small Volume Parenteral (Insulin)Non-beta lactam: • Small Volume Parenteral (Insulin)None03/12/2018 Report DateCompliantAmoreen Naluyima
61IRF/F/322/06/2018 R10 150/GMP/2018Boehringer Ingelheim Pharma GmbH & Co. KG,Birkendorfer Strasse 65, 88397 Biberach an der Riss, GermanyGermany23/04/201823/04/2021BiologicsBiologics • Small Volume ParenteralsBiologics • Small Volume ParenteralsNone31/08/2018 CAPA SUBMITTEDCompliantOnen Solomon L.
62IRF/F/383/09/2018 R12 113/GMP/2019 Cert No.Botswana Vaccine Institute LtdPlot 6385/90, Lejara Road, Broadhurst Industrial GaboroneBotswana24/08/201824/08/2021Non Beta lactam (Foot and Mouth Disease Vaccine)Non Beta lactam (Foot and Mouth Disease Vaccine) • Aftovax • AftovaxpurNon Beta lactam (Foot and Mouth Disease Vaccine) • Aftovax • AftovaxpurNone08th September 2018 REPORT DATECompliantKaleebu Frank
63IRF/F/182/01/2018- R8 053/GMP/2018Cachet Pharmaceuticals Pvt. Ltd.P&V: Thana, Baddi, Distt.-Solan-H.P. IndiaIndia28/11/201728/11/2020Non-beta lactamNon-beta lactam Oral Liquids, Tablets Capsules Sachets (Oral Powder)Non-beta lactam Oral Liquids, Tablets Capsules Sachets (Oral Powder)None20/03/2018 CAPA SUBMISSIONCompliantDennis Mwesigwa
64IRF/F/208/02/2018Cadila Healthcare LimitedSarkhej-Bavla N.H No; 8A Moraiya, Tal Sanand, District- Ahmedabad 382210-IndiaIndia07/11/2017Non-beta lactamTab (Coated & Uncoated) Cap (HGC & SGC) SVP Liquid Injections in Ampoules & SVP liquid injectable in vials Lyophilized SVP Powders in Vials Metered Dose Inhalers and Nasal Sprays Lyophilized anti-rabies vaccineTab (Coated & Uncoated) Cap (HGC & SGC) SVP Liquid Injections in Ampoules & SVP liquid injectable in vials Lyophilized SVP Powders in Vials Metered Dose Inhalers and Nasal Sprays Lyophilized anti-rabies vaccineNone07/11/2018 GMP Issue dateCompliantEtuko Daniel
65IRF/F/347/07/2018 R11 006/GMP/2019 GMP Cert No.Caspian Tamin Pharmaceutical Co.Entrance 1, Rasht Industrial City, Rasht, Iran.India16/05/201816/05/2021Non Beta-lactam:Non Beta-lactam: • Small Volume ParenteralsNon Beta-lactam: • Small Volume ParenteralsNoneCAPA SubmittedCompliantEtuko Daniel
66IRF/F/062/04/2019 129/GMP/2019 Cert No.CCL Pharmaceuticals (Pvt) Limited62 Industrial Estate, Kot Lakhpat, Lahore. PakistanPakistan07/12/201807/12/2021Non-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 injectionsNone02/04/19 GMP Report Date, 31/05/19 CAPA SubmittedCompliantDenis Mwesigwa
67IRF/F/006/01/2019 092/GMP/2019 Cert No.Celon Laboratories Private LimitedPlot No.2, Aleap Industrial Estate, Gajularamaram, Ranga Reddy District- 500 090 Telangana state, IndiaIndia16/11/201816/11/2021Non-Beta LactamNon-Beta Lactam • Tablets (coated and uncoated) • Hard Gelatin Capsules • SVP-Solution (Cytotoxic products) • SVP-Solution & LyophilizedNon-Beta Lactam • Tablets (coated and uncoated) • Hard Gelatin Capsules • SVP-Solution (Cytotoxic products) • SVP-Solution & LyophilizedNone21/01/2019 Report DateCompliantOkello Andrew
68IRF/F/354/08/2018 R12 127/GMP/2018Cenexi S.A.S52, rue Marcel et Jacques Gaucher 94120 Fontenay-sous-Bois- FranceFrance24/07/2018Non-beta lactam:Non-beta lactam: • Tablets (coated and uncoated)Non-beta lactam: • Tablets (coated and uncoated)None15th August 2018 Report DateCompliantKaleebu Frank
69IRF/F/302/04/2018 R10 109/GMP/2018Centaur Pharmaceuticals Pvt. Ltd (Plant 1)Plot 3,5B, 2C Tivim Industrial Estate, Karasvada, Mapusa, Goa 403526 – IndiaIndia13/03/201813/03/2021Non Beta-lactamNon Beta-lactam • Tablets (Coated and Uncoated) • Syrups • Eye, Ear and Nasal DropsNon Beta-lactam • Tablets (Coated and Uncoated) • Syrups • Eye, Ear and Nasal DropsNone23/07/2018 CAPA SUBMISSIONCompliantNahamya David
70IRF/F/301/04/2018 R10 123/GMP/2018Centaur Pharmaceuticals Pvt. Ltd (Plant 2)Plot No 39-41Tivim Industrial Estate, Karaswada - Mapusa, Goa-403526, IndiaIndia16/03/201816/03/2021Non Beta-lactamNon Beta-lactam • Opthalmic ointments • Topical ointments, creams and GelsNon Beta-lactam • Opthalmic ointments • Topical ointments, creams and GelsNone04/07/2018 CAPA SUBMITTEDCompliantNahamya David
71140/GMP/2018 DRCeva Sante AnimaleZone Industrielle Tres Le Bois, BP 372,22603 Loudeac, Cedex- FranceFrance07/09/201807/09/2021Beta Lactam Non Beta LactamBeta Lactam Tablet (coated and uncoated) Capsules Oral Powders Non Beta Lactam Oral Liquids Powders/Granules for Injection Reproductive Hormonal devices Tablets (coated and uncoated) Oral PowdersBeta Lactam Tablet (coated and uncoated) Capsules Oral Powders Non Beta Lactam Oral Liquids Powders/Granules for Injection Reproductive Hormonal devices Tablets (coated and uncoated) Oral PowdersNoneCompliantDenis Mwesigwa
72IRF/F/126/11/2017 - R5 043/GMP/2018Ceva Sante Animale91 Rue de Cambodge, Dubosville, 1009 Tunis, TunisiaTunisia26/09/201726/09/2020Vet NBL• Oral Powders • Oral Liquids• Oral Powders • Oral LiquidsNone01/03/2018 CAPA SUBMITTEDCompliantNasser Lubowa
73IRF/F/436/12/2018 074/GMP/2019 GMP Cert No.CEVA-PHYLAXIA Zrt1107 Budapest, Szallas u.5, HungaryHungary30/10/2018Veterinary production line(s)Veterinary production line(s): • Inactivated viral and bacterial vaccines in SVP vials (liquids and freeze-dried) • Live attenuated viral and bacterial vaccines in SVP vials (Liquids and freeze-dried)Veterinary production line(s): • Inactivated viral and bacterial vaccines in SVP vials (liquids and freeze-dried) • Live attenuated viral and bacterial vaccines in SVP vials (Liquids and freeze-dried)None05/12/2018 Report DateCompliantLukwago Mohammad
74038/GMP/2018 DRChinoin Pharmaceutical and Chemicals Works Private Co. Ltd Csanyikvolgy SiteCsanyikvolgy, P.O. Box 565. 3510, Miskolc, HungaryHungary19/03/201819/03/2021Non Beta LactamSmall Volume Parenteral LiquidsSmall Volume Parenteral LiquidsNone28/02/2018 Additional infor submittedCompliantMwesigwa Denis
75IRF/F/149/12/2017- R6CIPLA INDORE (UNIT I, II, III & IV)Plot No. 9, 10 and 15, Indore Special Economic Zone, Phase –II, Pithampur, District Dhar, Pin Code: 454775, Madhya PradeshIndia10/10/2017Non beta-lactam.Sterile Products Form Fill Seal (FFS) SVP; Respules and Eye-drops. Three piece eye-drop (SVP) Non-Sterile Oral liquids Pressurized Metered dose inhalers Hard Gelatin Capsules Tablets coated and uncoated Sachets Powder for Inhalation Nasal SpraySterile Products Form Fill Seal (FFS) SVP; Respules and Eye-drops. Three piece eye-drop (SVP) Non-Sterile Oral liquids Pressurized Metered dose inhalers Hard Gelatin Capsules Tablets coated and uncoated Sachets Powder for Inhalation Nasal SprayNoneCompliantKenneth Kiiza
76IRF/F/014/02/2019 029/GMP/2019 GMP Cert No.Cipla LimitedUnit X, L-139, S-103 & M-62 Verna Industrial Estate, Verna Salcette Goa- IndiaIndia05/12/2018Non-beta Lactam (Cytotoxic)Non-beta Lactam (Cytotoxic): • Tablets (coated and uncoated) • Hard gelatin capsules • Soft gelatin capsulesNon-beta Lactam (Cytotoxic): • Tablets (coated and uncoated) • Hard gelatin capsules • Soft gelatin capsulesNone04th February 2019 Report DateCompliantNambasa Victoria
77IRF/F/054/03/2019 170/GMP/2019 Cert No.Cipla LimitedMIDC Patalganga, Dist. Raigad – 410220 Maharashtra. Plot No. A-33, A-2 & A-37/2/2 (Unit-I), A-42(Unit-II), IndiaIndia30/11/201830/11/2021Non-?eta lactam ActivitiesNon-?eta lactam • Tablets (Coated and Uncoated) Activities • Manufacture of finished pharmaceutical productNon-?eta lactam • Tablets (Coated and Uncoated) Activities • Manufacture of finished pharmaceutical productNone21st March 2019 Report dateCompliantNasser Lubowa
78IRF/F/172/01/2018- R8 013/GMP/2018 GMP CERTCipla LtdCipla Limited Plot Nos. L-139,S-103 & M-62 Verna Industrial Estate, Verna Salcette Goa (Unit IX ,III,IV,VII,I,II,Viii)India15/12/201715/12/2020Non Beta LactamLVP SVP Lyophilisates Liposome Inj (prefilled injections) Svp Caps Tabs SVP (Aseptic) Creams & Topical Solutions Metered Dose Inhalers Creams/Gels/Ointment Respiratory Solutions Respiratory Suspensions Nasal Sprays Eye DropsLVP SVP Lyophilisates Liposome Inj (prefilled injections) Svp Caps Tabs SVP (Aseptic) Creams & Topical Solutions Metered Dose Inhalers Creams/Gels/Ointment Respiratory Solutions Respiratory Suspensions Nasal Sprays Eye DropsNone12/01/2018 GMP CERT ISSUE DATECompliantKaleebu Frank
79IRF/F/097/07/2019 (EAC) 045/GMP/2020 GMP Cert No.Cipla Quality Chemical Industries LimitedPlot 1-7, Ring Road, Luzira Industrial Park - UgandaUganda26/04/201926/04/2022Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNonw10th July 2019 Report dateCompliantDennis Mwesigwa
80IRF/F/163/01/2018- R7 055/GMP/2018Claris Injectables LimitedVasana-Chacharwadi, Tal-Sanand-382 213, IndiaIndia17/11/201717/11/2020Non- Beta lactam• Small Volume Parenterals (vials and ampuoles) • Small Volume Parenterals (emulsions and aqueous solutions in glass bottles)• Small Volume Parenterals (vials and ampuoles) • Small Volume Parenterals (emulsions and aqueous solutions in glass bottles)None28/03/2018 CAPA SubmittedCompliantVictoria Kwesiga
81IRF/F/193/01/2018- R8 036/GMP/2018Comed chemicals Ltd (Unit-III)Vill: Dassomatra Baddi, Nalagargh Road District: Solan, Pin.173205 Himachal Pradesh India.India15/12/201715/12/2020Non-Beta lactam Beta lactam (Cephalosporins)Non-Beta lactam • Tablets • Hard gelatin capsules Beta lactam (Cephalosporins) • Tablets • Dry syrupNon-Beta lactam • Tablets • Hard gelatin capsules Beta lactam (Cephalosporins) • Tablets • Dry syrupNone27/02/2018 CAPA SUBMITTEDCompliantMutyaba Michael
82IRF/F/059/03/2019 121/GMP/2019 Cert No.Concept Pharmaceuticals LimitedKishanpur Jamalpur Roorkee Dist Haridwar -247667 Uttarakhand, India.India30/11/201830/11/2021Non-Beta LactamNon-Beta Lactam • Small Volume Parenteral solutions (human and veterinary) • Tablets (coated and uncoated) • Hard gelatin CapsulesNon-Beta Lactam • Small Volume Parenteral solutions (human and veterinary) • Tablets (coated and uncoated) • Hard gelatin CapsulesNone21st March 2019 Report dateCompliantOnen Solomon L.
83IRF/F/021/02/2019 077/GMP/2019 GMP Cert No.Copmed Pharmaceuticals Pvt Ltd, Unit IIPlot No. 50, Gondpur Industrial Area Paonta Sahib, District Sirmour, Himachal Pradesh-173025, IndiaIndia23/11/2018Beta LactamBeta Lactam • Cephalosporin (Tablets and Powders for oral suspension) • Penicillin (Tablets and Powders for oral suspension)Beta Lactam • Cephalosporin (Tablets and Powders for oral suspension) • Penicillin (Tablets and Powders for oral suspension)None11th February 2019 Report DateCompliantAtumanya Amos
84081/GMP/2019 DRCorden Pharma SpAViale Dell’Industria 3, 20867, Caponago (MB) – UP1 (production unit 1) - ItalyItaly23/05/201923/05/2022Non-Beta LactamNon-Beta Lactam: SVP (Terminally sterilized)Non-Beta Lactam: SVP (Terminally sterilized)NoneCompliantKaleebu Frank
85IRF/F/056/03/2019 128/GMP/2019 Cert No.Corona Remedies Pvt. LimitedVillage: Jatoli, Post Office- Oachghat, Tehsil Solan, Dist. Solan (Himachal Pradesh) - 173223, IndiaIndia11/12/201811/12/2021Non 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)None21st March 2019 Report dateCompliantNasser Lubowa
86IRF/F/424/10/2018 018/GMP/2019 GMP Cert No.CSPC Ouyi Pharmaceutical Company LimitedWorkshops 112, 113 and 117; Plot No. 88 Yangzi Road, Economic and Technological Development Zone, Shijiazhuang City Hebei Province.China17/08/201817/08/2021Non beta lactam Beta Lactam (Carbapenems)Non beta lactam: • Tablets (Coated and Uncoated) • Hard Gelatin Capsules and granules • SVP - Solutions in Ampoules, Aseptically filled and Terminally Sterilised Beta Lactam: • Small Volume Parenterals - Sterile Powders for InjectionNon beta lactam: • Tablets (Coated and Uncoated) • Hard Gelatin Capsules and granules • SVP - Solutions in Ampoules, Aseptically filled and Terminally Sterilised Beta Lactam: • Small Volume Parenterals - Sterile Powders for InjectionNoneCAPA SubmittedCompliantNasser Lubowa
87IRF/F/416/10/2018 017/GMP/2019 GMP Cert No.CSPC Zhongnuo Pharmaceuticals (Shijiazhuang) Co. LtdNo. 88 Yangzi Road, Economic &Technological, Development Zone, Shijiazhuang, Hebei, People’s Republic of China.China14/08/201814/08/2021Beta Lactam (Penicillins)Beta Lactam (Penicillins): • Tablets (Coated and Uncoated) • Hard Gelatin Capsules • Dry Oral Powders/Granules for Suspension • Small Volume Parenterals- Sterile Powders for Injection in VialsBeta Lactam (Penicillins): • Tablets (Coated and Uncoated) • Hard Gelatin Capsules • Dry Oral Powders/Granules for Suspension • Small Volume Parenterals- Sterile Powders for Injection in VialsNoneCAPA SubmittedCompliantNasser Lubowa
88IRF/F/087/06/2019 130/GMP/2019 Cert No.Curetech SkincarePlot No. 33 & 34, Phase IV, Bhatoli Kalan, Baddi, Distt. Solan (H.P) 173205, IndiaIndia12/03/201912/03/2022Non-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)None26th June 2019 Report DateCompliantKenneth Kiiza
89IRF/F/356/08/2018 R12 048/GMP/2019 GMP Cert No.Cyndea Pharma S.LPoligono Industrial Emiliano Revilla Sanz. Avenida, 31, Olvega, 42110 Soria, SpainSpain31/07/2018Non-beta lactam (sex-hormones):Non-beta lactam (sex-hormones): • Soft gelatin capsulesNon-beta lactam (sex-hormones): • Soft gelatin capsulesNoneCompliantKaleebu Frank
90IRF/F/214/03/2018- R8 144/GMP/2018Dawa LimitedPlot No. 7879/8 Babadogo Road, Ruaraka P. O. Box 16633-00620 Nairobi, KenyaKenya28/02/201828/02/2021Beta Lactam (Penicillins) Non Beta LactamBL (Penicillins) Hard Gelatin Capsules Powders for Oral Suspension NBL Coated and Uncoated Tablets Hard Gelatin Capsules Oral Liquids- Syrups and Suspensions Powders for Oral Suspension Creams, Ointments and External SolutionsBL (Penicillins) Hard Gelatin Capsules Powders for Oral Suspension NBL Coated and Uncoated Tablets Hard Gelatin Capsules Oral Liquids- Syrups and Suspensions Powders for Oral Suspension Creams, Ointments and External SolutionsNone16/07/2018 CAPA SUBMISSIONCompliantNasser Lubowa
91024/GMP/2019 DRDelpharm Milano S.R.LVia Carnavale 1 20090 Segrate (Milan Italy), ItalyItaly28/01/201928/01/2022Non-Beta LactamNon-Beta Lactam TabletsNon-Beta Lactam TabletsNoneCompliant
92IRF/F/008/01/2019 014/GMP/2019 GMP Cert No.Demo SA Pharmaceutical Industry21st Km National Road, Athens, Lamia 14568 Kryoneri, Attiki, GreeceGreece16/10/2018filling of Small Volume Parenterals (penems)filling of Small Volume Parenterals (penems)filling of Small Volume Parenterals (penems)None22/01/2019 Report DateCompliantAmoreen Naluyima
93147/GMP/2018 DRDenk Pharma GmbH & Co. KGGollstr. 1, 84529 Tittmoning, GermanyGermany14/09/201814/09/2021Non Beta LactamTablets Hard Gelatin CapsulesTablets Hard Gelatin CapsulesNoneCompliantDenis Mwesigwa
94IRF/F/042/02/2019 GMp Cert No. 009/GMP/2020Deva Holdings A.S.Cerkezkoy Organize Sanayi Bolgesi, Karaagac Mah., Ataturk Cad., No.: 32 Kapakli Tekirdag - TurkeyTurkey23/10/201823/10/2021Non-beta lactam Penicllins Cephalosporins InhalersNBL Tablets Hard gelatin capsules Oral liquids Dry powder for suspension Semi solids Penicllins Tablets Dry powder for suspension Caphalosporins Tablets Dry powder for suspension Powders for injection Inhalers Metered dose inhalersNBL Tablets Hard gelatin capsules Oral liquids Dry powder for suspension Semi solids Penicllins Tablets Dry powder for suspension Caphalosporins Tablets Dry powder for suspension Powders for injection Inhalers Metered dose inhalersNone11th February 2019 Report DateCompliantAmoreen Naluyima
95IRF/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, KenyaKenya26/04/201926/04/2022Oral 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, OintmentsNone05th July 2019 Report DateCompliantDennis Mwesigwa
96137/GMP/2018 DREli Lilly and CompanyLilly Technology Center, Building 312/314, 360,401, Indianapolis, In, 46221, United StatesUnited States Of America07/09/201807/09/2021BiologicalSmall Volume Parenteral (Insulin)Small Volume Parenteral (Insulin)NoneCompliantDenis Mwesigwa
97IRF/F/399/10/2018 R12 190/GMP/2018 GMP Cert No.Emcure Pharmaceuticals LimitedLane 03, Phase II, SIDCO Industrial Complex, Bari Brahmana Jammu India.India28/08/201828/08/2021Non beta-lactamNon beta-lactam. • Tablets. • Hard gelatin capsules. • Oral liquidsNon beta-lactam. • Tablets. • Hard gelatin capsules. • Oral liquidsNone06/11/2018 CAPA SubmittedCompliantVictoria Kwesiga
98IRF/F/015/02/2019 030/GMP/2019 GMP Cert No.Encube Ethicals Pvt. LimitedPlot no. C-1,Madkaim Industrial Estate, Madkaim, Post Mardol, Ponda, Goa-403404, IndiaIndia30/11/2018Non-Beta LactamNon-Beta Lactam: - Topical semi solid preparations (creams, gels, ointments and lotions)Non-Beta Lactam: - Topical semi solid preparations (creams, gels, ointments and lotions)None04th February 2019 Report DateCompliantNambasa Victoria
99IRF/F/155/12/2017-R6 039/GMP/2018Entrance Pharmaceuticals & Research Centre16, Okpoi Gonno, Light Industrial area, Spintex Road, P.O. Box CT10805 Accra, GhanaGhana15/11/201715/11/2020Non Beta Lactam Beta LactamNon Beta Lactam • Coated and Uncoated Tablets • Hard Gelatin Capsules • Oral Powders for Suspension • Oral Liquids Beta Lactam • Hard Gelatin Capsules • Oral Powders for SuspensionNon Beta Lactam • Coated and Uncoated Tablets • Hard Gelatin Capsules • Oral Powders for Suspension • Oral Liquids Beta Lactam • Hard Gelatin Capsules • Oral Powders for SuspensionNone27/02/2018 CAPA SubmittedCompliantMutyaba Michael
100IRF/L/034/02/2019 153/GMP/2019 Cert No.Eram Pharmaceutical Industries LimitedLugazi, along Jinja – Kampala Highway, Buikwe DistrictUganda17/01/201917/01/2022Non beta-lactamNon beta-lactam: • Oral liquids • Oral powders in sachetsNon beta-lactam: • Oral liquids • Oral powders in sachetsNone14th February 2019 Report DateCompliant
101020/GMP/2019 DREver Pharma Jena GmbhOtto-Schott-Str. 15, Jena Thueringen, 07745, GermanyGermany23/01/201923/01/2022Aseptically 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 ImplantsNoneCompliantKaleebu Frank
102023/GMP/2019 DREver Pharma Jena GmbhBruseller Str. 18, 07747, GermanyGermany30/01/201930/01/2022Aseptically Prepared (Secondary Packaging Only)Aseptically Prepared (Secondary Packaging Only) Small Volume ParenteralsAseptically Prepared (Secondary Packaging Only) Small Volume ParenteralsNoneCompliantDenis Mwesigwa
103IRF/F/441/12/2018 213/GMP/2018 GMP Cert No.Famar Orleans SAS5 Avenue De Concyr, F-45071 Orleans, Cedex 2, FranceFrance23/10/2018Non-beta lactamNon-beta lactam: • Dispersible TabletsNon-beta lactam: • Dispersible TabletsNone31/12/2018 Report DateCompliantKeneth Kiiza
104IRF/F/063/04/2019 118/GMP/2019 Cert No.FARMAPRIM5 Crinilor Street, Porumbeni, Criuleni District, MD 4829, Republic of MoldovaMoldova10/12/201810/12/2021Non-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 • GelsNone05th April 2019 GMP Report Date, 24/05/2019 CAPA SubmittedCompliantPeter Ssali
105IRF/F/433/11/2018 192/GMP/2018 GMP Cert No.Farmasierra Manufacturing S.LCarretera de Irun, Km. 26,200 28709 San Sebastian De los Reyes, Madrid, SpainSpain26/10/2018Non-beta lactamNon-beta lactam: • Ophthalmic suspensions and ointmentsNon-beta lactam: • Ophthalmic suspensions and ointmentsNone30th November 2018 Report dateCompliantLukwago Mohammad
106IRF/F/361/08/2018 R12 011/GMP/2019 GMP Cert No.FDC LimitedL-56 & L-57 Phase II D Verna Industrial Estate, Verna- 403722, Salcete Goa IndiaIndia27/07/201827/07/2021Non Beta lactamNon Beta lactam • Tablets • Hard gelatin capsules • Oral rehydration salt(ORS)Non Beta lactam • Tablets • Hard gelatin capsules • Oral rehydration salt(ORS)None21/11/2018 CAPA SUBMITTEDCompliantOkello Andrew
107IRF/F/136/11/2017- R6 094/GMP/2018FDC Limited (Unit III)Plot L-121B, Phase 111A, Verna Industrial Estate, Verna, Salcete, Goa- 403 722, India.India13/10/201713/10/2020Non Beta Lactam• Tablets (Coated and Uncoated)• Tablets (Coated and Uncoated)None10/05/2018 CAPA SubmittedCompliantKeneth Kiiza
108IRF/F/144/11/2017- R6 035/GMP/2018Ferozsons Laboratories Ltd.Amangarh-Nowshera, (Khyber, Pakhtunkhwa), PakistanPakistan20/10/201720/10/2020Non Beta Lactam• Tablets (coated and uncoated) • Semi-solids (ointments and creams) • Hard gelatin capsules (filling and packaging) • Dry powders for oral suspension• Tablets (coated and uncoated) • Semi-solids (ointments and creams) • Hard gelatin capsules (filling and packaging) • Dry powders for oral suspensionNone15/02/2018 CAPA SubmittedCompliantZaidi Mwondha
109065/GMP/2018 DRFerrer International, S.AC/ Joan Buscalla, 1-9 08173 Sant Cugat del Valles, Spain.Spain08/05/201808/05/2021Non Beta LactamTablets (Coated and Uncoated) Small Volume Parenterals Hard Gelatin Capsules Oral Liquids Creams, Ointment and Gels Lyophilates- SVPTablets (Coated and Uncoated) Small Volume Parenterals Hard Gelatin Capsules Oral Liquids Creams, Ointment and Gels Lyophilates- SVPNone08th May 2018 Report DateCompliantDenis Mwesigwa
110IRF/F/372/09/2018 R12 133/GMP/2018Fisons Limited72 London Road, Holmes Chapel Crewe, Cheshire, CW4 8BE, United Kingdom.United Kingdom20/06/2018Non beta-lactamNon beta-lactam. • Metered Dose Inhalers (aerosols)Non beta-lactam. • Metered Dose Inhalers (aerosols)None07th September 2018 Report DateCompliantWilberforce Kwiringira
111073/GMP/2018 DRFleet Laboratories Limited94 Rickmansworth Road,Watford , WD18 7JJ, United KingdomUnited Kingdom24/05/201824/05/2021HormonalCreams and GelsCreams and GelsNone24th May 2018 Report DateCompliantDenis Mwesigwa
112IRF/F/362/08/2018 R12 129/GMP/2018Fourrts (India) Laboratories Pvt Ltd Plant- IIPlot No.23 Venkatamangalam, Kandigai Chennai-600127India24/07/2018Non beta-lactam.Non beta-lactam. • Tablets • Hard gelatin capsulesNon beta-lactam. • Tablets • Hard gelatin capsulesNone30th August 2018 Report DateCompliantOkello Andrew
113IRF/F/181/01/2018- R9 078/GMP/2018 Cert No.Fredun Pharmaceuticals Limited14,15,16, Zorabian Industrial Complex,Veoor,Palghar (E), Dist: Palghar-401 404 IndiaIndia08/12/201708/12/2020Non-beta lactamNon-beta lactam • Tablet • Capsule • Dry powder for oral suspensionNon-beta lactam • Tablet • Capsule • Dry powder for oral suspensionNone 25/01/2018 Report date18/05/2018 CAPA SUBMITTEDCompliantDennis Mwesigwa
114IRF/F/304/04/2018 R10 120/GMP/2018Fresenius Kabi ABRapsgatan 7, Uppsala, Se-751 74, SwedenSweden29/03/201829/03/2021Non Beta-lactamNon Beta-lactam • Large volume parenterals in three chamber bags • Small volume parenterals in ampoulesNon Beta-lactam • Large volume parenterals in three chamber bags • Small volume parenterals in ampoulesNone23rd April 2018 Report dateCompliantKaleebu Frank
115IRF/F/108/07/2019 147/GMP/2019 Cert No.Fresenius Kabi India Private LimitedA-3,MIDC,Ranjangm Gampati,shirwi pune-412220India30/04/201930/04/2022Non-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)None16th July 2019 Report dateCompliantVictoria Kwesiga
116IRF/F/031/02/2019 117/GMP/2019 Cert No.Galentic Pharma (India) Pvt Ltd Unit IR-673,TTC,MIDC,Thane Belapur Road Navi Mumbai-400701. India.India27/11/201827/11/2021Non-beta LactamNon-beta Lactam: • Sterile Ophthalmic ointments and gels. • Non sterile ointments, gels, creams and lotions.Non-beta Lactam: • Sterile Ophthalmic ointments and gels. • Non sterile ointments, gels, creams and lotions.None14th February 2019 Report DateCompliantZaid Mwonda
117IRF/F/365/09/2018 R12 131/GMP/2018Galpha Laboratories LimitedVillage-Thana Baddi, Tehsil Baddi Solan Himachal Pradesh-173 205 IndiaIndia28/07/2018Non beta-lactamNon beta-lactam. • Hard gelatin Capsules • Tablets • Oral liquids for human useNon beta-lactam. • Hard gelatin Capsules • Tablets • Oral liquids for human useNone03 September 2018 REPORT DATECompliantZaidi Mwondha
118115/GMP/2018 DRGedeon Richter PlcH-1103 Budapest, Gyomroi ut 19-21 HungaryHungary18/07/201818/07/2021Non Beta LactamTablets ( Hormones)Tablets ( Hormones)NoneCompliantDenis Mwesigwa
119IRF/F/410/10/2018 GMP Cert No. 026/GMP/2019General Pharmaceuticals Limited (Unit 2)Karolsurichala, Mouchak, Kaliakoir, Gazipur – Bangladesh.Bangladesh20/09/201820/09/2021Non-beta lactam sterile SVP preparationsNon-beta lactam sterile SVP preparations: General preparations (Non-steroid) • Ampoules. • Ophthalmic preparations (in LDPE bottles). • Pre-filled syringes. Steroid preparations • Ophthalmic preparations (in LDPE Bottles)Non-beta lactam sterile SVP preparations: General preparations (Non-steroid) • Ampoules. • Ophthalmic preparations (in LDPE bottles). • Pre-filled syringes. Steroid preparations • Ophthalmic preparations (in LDPE Bottles)None18th October 2018 Report DateCompliant
120IRF/F/313/06/2018 R10 093/GMP/2018Gilead Sciences Ireland Uc,CorkIDA Business & Technology Park, Carrigtohill, County Cork, Ireland.Ireland20/04/201820/04/2021Non-beta lactamNon-beta lactam • Tablets ( by dry granulation ). • Primary and secondary packaging for tablets and Oral powder for reconstitution.Non-beta lactam • Tablets ( by dry granulation ). • Primary and secondary packaging for tablets and Oral powder for reconstitution.None06th June 2018 Report dateCompliantOkello Andrew
121IRF/F/012/01/2019 022/GMP/2019 GMP Cert NoGland Pharma LimitedSurvey No. 143 to 148, 150 & 151, D.P.Pally, Dundigal Post, Dundigal – Gandimaisamma Mandal, Medchal-Malkajgiri District, Hyderabad- 500 043 TelanganaIndia20/11/2018Non-Beta lactamNon-Beta lactam • SVP (Liquid Ampoules and Liquid vials)Non-Beta lactam • SVP (Liquid Ampoules and Liquid vials)None31st January 2019 REPORT DATECompliantOkello Andrew
122IRF/F/400/09/2018 R12 151/GMP/2018 GMP CERT NoGland Pharma LtdPlot No.42 to 52,Sy No.166,171,172 & 177,TSIIC,Phase111,Pashamylaram(V) Patancheru (M),Medak District 502307 Telangana state, IndiaIndia21/08/201821/08/2021Non Beta LactamNon Beta Lactam • Aseptically filled SVP solution in glass ampoules (suite 7) • Aseptically filled SVP Lyophilizate in glass vials (suite 2)Non Beta Lactam • Aseptically filled SVP solution in glass ampoules (suite 7) • Aseptically filled SVP Lyophilizate in glass vials (suite 2)None28th September, 2018 REPORT DATECompliantVictoria Kwesiga
123080/GMP/2019 DRGlaxo Operations UK Limited (Trading as Glaxo Wellcome Operations)Priory Street, Ware, SG120DJ – United KingdomUnited Kingdom22/05/201922/05/2022Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneCompliantKaleebu Frank
124191/GMP/2018 DRGlaxo Operations UK LtdHarmire Road, Barnard Castle, Durham, DL 12 8DTUnited Kingdom30/11/2018Cephalosporin Non-Beta LactamCephalosporin Tablets Oral dry powders for suspension Non-Beta Lactam Pressurised inhalers Semi solidsCephalosporin Tablets Oral dry powders for suspension Non-Beta Lactam Pressurised inhalers Semi solidsNoneCompliantKaleebu Frank
125075/GMP/2018 DRGlaxo Wellcome ProductionZone Industrielle No. 2, 23, rue Lavoisier, 27 000 Evreux, France.France25/05/201825/05/2021Non Beta LactamPressurised preparations(Inhalers)Pressurised preparations(Inhalers)None25th May 2018 Report DateCompliantDenis Mwesigwa
126170/GMP/2017 - DRGlaxo Wellcome ProductionZI de la Peyenniere, 53100, MayenneFrance08/11/201708/11/2020Beta lactamOral powder for suspension Tablets Hard Gelatin CapsulesOral powder for suspension Tablets Hard Gelatin CapsulesNoneCompliantMwesigwa Denis
127027/GMP/2019 DRGlaxosmithkline Manufacturing S.P.AVia A. Fleming, 2-37135 Verona - ItalyItaly31/01/201931/01/2022CephalosporinCephalosporin: Small Volume ParenteralsCephalosporin: Small Volume ParenteralsNoneCompliant
128170/GMP/2018 DRGlaxoSmithKline Manufacturing SpAStrada Provinciale Asolana N.90 (Loc. San Polo), Torrile (PR), 43056, Italy.Italy30/10/201830/10/2021Non-Beta LactamNon-Beta Lactam Small Volume Parenteral Solutions (Aseptically filled and terminally sterilised in ampoules and vials)Non-Beta Lactam Small Volume Parenteral Solutions (Aseptically filled and terminally sterilised in ampoules and vials)NoneCompliantKaleebu Frank
129IRF/F/124/11/2017 - R5 034/GMP/2018GlaxoSmithKline SAEP.O Box 3001; El Salam City, 11491, 1 Amoun Street, Cairo EgyptEgypt30/09/201730/09/2020NBL• Coated and Uncoated Tablets • Hard Gelatin Capsules • Soft Gelatin Capsules • Oral Liquids- Solutions, Suspensions and Drops• Coated and Uncoated Tablets • Hard Gelatin Capsules • Soft Gelatin Capsules • Oral Liquids- Solutions, Suspensions and DropsNone25/02/2018 CAPA SUBMISSIONCompliantNasser Lubowa
130044/GMP/2019 DRGlaxoSmithKline, LLC1011 North Arendell Avenue Zebulon, North Carolina 27597, USA.United States Of America12/02/201912/02/2022Non-Beta LactamNon-Beta Lactam: Pressurised preparations (Multi-dose powder inhalation)Non-Beta Lactam: Pressurised preparations (Multi-dose powder inhalation)NoneCompliant
131IRF/F/027/02/2019 041/GMP/2019 GMP Cert No.Glenmark Pharmaceuticals LimitedVillage Kishanpura, Baddi, Nalagarh Road, Tehsil Baddi, Distt. Solan (H.P)-173205, IndiaIndia08/12/201808/12/2021Non-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 useNone14th February 2019 Report DateCompliantNambasa Victoria
132IRF/F/415/10/2018 210/GMP/2018 Cert No.Glenmark Pharmaceuticals LtdPlot E-37, 39, D road, MIDC, Satpur, Nashik 422007, Maharashtra State, India.India11/09/201811/09/2021Non-beta lactamNon-beta lactam: • Tablets (coated & uncoated) • Hard gelatin Capsules, • Oral Liquids, • External Powders • Medicated shampoo • External semi-solids (lotions, creams, drops, gels and ointments)Non-beta lactam: • Tablets (coated & uncoated) • Hard gelatin Capsules, • Oral Liquids, • External Powders • Medicated shampoo • External semi-solids (lotions, creams, drops, gels and ointments)NoneCAPA SubmittedCompliantAtumanya Amos
133IRF/F/127/11/2017- R5 032/GMP/2018Global Napi Pharmaceuticals2nd Industrial Zone, No.40 St. 18, 6th October City, EgyptEgypt12/10/201712/10/2020Non Beta Lactam• Tablets (Coated and Uncoated) • Hard Gelatin Capsules • Creams, Ointments and Suppositories• Tablets (Coated and Uncoated) • Hard Gelatin Capsules • Creams, Ointments and SuppositoriesNone24/01/2018 CAPA SUBMITTEDCompliantNasser Lubowa
134IRF/F/165/01/2018- R7 031/GMP/2018Globela Pharma Pvt LtdPlot No.357, G.I.D.C, Sachi Road No.3.Surat-394230, Gujarat, IndiaIndia24/11/201724/11/2020Non- Beta lactam;Tablets (coated and uncoated) Hard gelatin capsules Oral powder (Sachets and dry powder in bottles) Oncology line (tablets and hard gelatin capsules)Tablets (coated and uncoated) Hard gelatin capsules Oral powder (Sachets and dry powder in bottles) Oncology line (tablets and hard gelatin capsules)None15/02/2018 CAPA SubmittedCompliantVictoria Kwesiga
135IRF/F/420/10/2018 052/GMP/2019 GMP Cert No.Gufic Life Sciences Private Limited,Survey No. 171, N.H. No-8, Near Frid, Kabilpore, City- Navsari 396424, Dist. Navsari, Gujarat state, India.India25/09/2018Non beta lactamNon beta lactam: • Small volume parenterals (liquids & lyophilized powders in vials)Non beta lactam: • Small volume parenterals (liquids & lyophilized powders in vials)None26th October 2018 Report dateCompliantAtumanya Amos
136IRF/F/215/04/2018 R10 154/GMP/2018Guilin Pharmaceutical Co. LtdPlot No. 43, Qilidian Road, Guilin 541004-ChinaChina06/03/201806/03/2021Non Beta-lactamNon Beta-lactam • Tablets • Hard Gelatin Capsules • SVP powders for injection • SVP liquids (in Ampoules and vials) Aseptically filled & terminally sterilizedNon Beta-lactam • Tablets • Hard Gelatin Capsules • SVP powders for injection • SVP liquids (in Ampoules and vials) Aseptically filled & terminally sterilizedNone20/09/2018 CAPA SUBMITTEDCompliantEtuko Daniel
137098/GMP/2018 DRHaupt Pharma Wulfing GmbH.Bethelner Landstr. 18, 31028 Gronau/Leine, GermanyGermany19/06/201819/06/2021Non Beta lactamSmall Volume Parenterals (Liquids) SuppositoriesSmall Volume Parenterals (Liquids) SuppositoriesNoneCompliantDenis Mwesigwa
138IRF/F/045/02/2019 154/GMP/2019 Cert No.Hester Biosciences LimitedVillage; Merda-Adraj, Taluka: Kadi, District Mehsana Gujarat-382721 IndiaIndia04/12/201804/12/2021Veterinary production line(s)Veterinary production line(s): •Inactivated viral and bacterial vaccines in SVP vials (liquids and freeze-dried) •Live attenuated viral and bacterial vaccines in SVP vials ( liquids and freeze-dried)Veterinary production line(s): •Inactivated viral and bacterial vaccines in SVP vials (liquids and freeze-dried) •Live attenuated viral and bacterial vaccines in SVP vials ( liquids and freeze-dried)None21st February 2019 Report DateCompliantZaid Mwonda
139IRF/F/178/01/2018- R9 176/GMP/2018 GMP Cert No.Hetero Biopharma LimitedSy. No. 458 (Part), TSIIC-Formulation SEZ, Polepally Village, Jadcherla Mandal Mahaboobnagar District – 509 301, Telangana State, India.India15/12/201715/12/2020Non-beta lactamNon-beta lactam Small volume parenteral (Darbepoetin Alfa injection in pre filled syringe) – Biosimilar product –DERISE -40Non-beta lactam Small volume parenteral (Darbepoetin Alfa injection in pre filled syringe) – Biosimilar product –DERISE -40None26/09/2018 CAPA SUBMITTEDCompliantDennis Mwesigwa
140IRF/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, IndiaIndia19/03/2019Non-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)None12th July 2019 Report dateCompliantKenneth Kiiza
141IRF/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, IndiaIndia22/03/201922/03/2022Non-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 vialsNone12th July 2019 Report dateCompliantKenneth Kiiza
142IRF/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, IndiaIndia15/03/201915/03/2022Non-Beta LactamNon-Beta Lactam: • Inhalers (pressurised metered dose)Non-Beta Lactam: • Inhalers (pressurised metered dose)None30th June 2019 Report DateCompliantKenneth Kiiza
143IRF/F/188/01/2018- R8 016/GMP/2018 GMP CERTHetero Labs Private Limited Unit IIISurvey No. 51, Plot 22-110, industrial development area (I.D.A) Jeedimetla, Hyderabad-500 055, Telangana State, India.India21/11/2017Non-beta lactamNon-beta lactam • Hard shell capsules • Tablets (coated and Uncoated) • Oral liquidsNon-beta lactam • Hard shell capsules • Tablets (coated and Uncoated) • Oral liquidsNone29/01/2018 GMP ISSUE DATECompliantAnnet Ssekindu
144IRF/F/061/04/2019 104/GMP/2019 GMP Cert No.Hilton Pharmaceuticals (Pvt.) LimitedPlot No. 13-14, Sector 15, Korangi Industrial Area in Karachi-74900. PakistanPakistan30/11/201830/11/2021Non-beta lactam preparations Cephalosporin Veterinary, Non-beta lactam:Tablets Hard gelatin capsules Dry powder for oral suspension Oral liquid preparations SVPs Cephalosporin Dry powder for oral suspension Hard gelatin capsules Veterinary Oral liquid preparations Dry powder for oral suspensionTablets Hard gelatin capsules Dry powder for oral suspension Oral liquid preparations SVPs Cephalosporin Dry powder for oral suspension Hard gelatin capsules Veterinary Oral liquid preparations Dry powder for oral suspensionNoneCompliantDenis Mwesigwa
145IRF/F/213/03/2018 R9 085/GMP/2018Impact Chemicals LimitedKC Arora complex, Mombasa Road, KenyaKenya02/03/201802/03/2021Non-Beta lactam(Veterinary)Non-Beta lactam(Veterinary) • Ectoparasiticides (Acaricides)Non-Beta lactam(Veterinary) • Ectoparasiticides (Acaricides)None 29/03/2018 REPORT DATE09/05/2018 CAPA SUBMITTEDCompliantNasser Lubowa
146IRF/F/426/11/2018 203/GMP/2018 GMP Cert No.Indiana Ophthalamics135,136,137, G.I.D.C Estate Wadhvan 363035 - India.India28/09/201828/09/2021Non beta lactamNon beta lactam: • Sterile eye drops (solutions and suspensions) • Sterile eye ointmentsNon beta lactam: • Sterile eye drops (solutions and suspensions) • Sterile eye ointmentsNone13th November 2018 Report dateCompliantKaleebu Frank
147IRF/F/418/10/2018 019/GMP/2019 GMP Cert No.Inject Care Parenterals Pvt LimitedPlot No 130, Silvassa Road Gidc Vapi-396 195 Gujarat India.India21/09/201821/09/2021Aseptically filled beta lactam powderAseptically filled beta lactam powder: • Small volume parenterals (cephalosporins) • Small volume parenterals (penicillins)Aseptically filled beta lactam powder: • Small volume parenterals (cephalosporins) • Small volume parenterals (penicillins)NoneCAPA SubmittedCompliantAtumanya Amos
148IRF/F/369/09/2018 R12 211/GMP/2018 GMP Cert No.Innova Captab Pvt. Ltd1281/1, Hilltop, Industrial Estate, Near EPIP, Phase-1, Jharmajri, Baddi, Distt. Solan [H.P] India.India03/08/201803/08/2021Beta lactam (cephalosporin)Beta lactam (cephalosporin) • Small volume powders for injection • Tablets (coated and uncoated) • Hard Gelatin Capsules • Powders for oral useBeta lactam (cephalosporin) • Small volume powders for injection • Tablets (coated and uncoated) • Hard Gelatin Capsules • Powders for oral usePending CAPA SUBMISSIONCAPA SubmittedCompliantAtumanya Amos
149IRF/F/336/06/2018 106/GMP/2018Intas Pharmaceuticals Ltd (Biopharma Division)Plot No. 423/P/A, Sarkhej-Bavla Highway, Moraiya, Taluka Sanand, Ahmedabad- 382213, Gujarat, IndiaIndia27/04/2018Non-Beta LactamNon-Beta Lactam • Small volume parenterals (Biologicals) packed in Vials, Prefilled syringes and cartridges.Non-Beta Lactam • Small volume parenterals (Biologicals) packed in Vials, Prefilled syringes and cartridges.None29th June 2018 Report DateCompliantAnnet Ssekindu
150IRF/F/077/05/2019 083/GMP/2019 Cert No.Intervet International B.V.Wim de Körverstraat 35 5831 AN Boxmeer, The NetherlandsNetherlands04/12/2018Biological (vaccines)Biological (vaccines): • Live freeze-dried (multivalent) vaccines (for veterinary use) • Live frozen poultry vaccines (for veterinary use)Biological (vaccines): • Live freeze-dried (multivalent) vaccines (for veterinary use) • Live frozen poultry vaccines (for veterinary use)None24th May 2019 GMP Report DateCompliantPeter Ssali
151IRF/F/179/01/2018- R9 051/GMP/2018Intracin Pharmaceutical Pvt. Ltd.C-1B/53, G.I.D.C. Estate, Nadiad 387 001, Gujarat India.India04/12/201704/12/2020Non-beta lactam Beta-lactam (cephalosporin)Non-beta lactam Liquid injectable production line (SVP) Beta-lactam (cephalosporin) Dry powder for Injection (SVP)Non-beta lactam Liquid injectable production line (SVP) Beta-lactam (cephalosporin) Dry powder for Injection (SVP)None29/03/2018 CAPA SUBMISSIONCompliantDennis Mwesigwa
152IRF/F/342/07/2018 R11 056/GMP/2019 GMP Cert No.Inventia Healthcare Pvt. LimitedF1-F1/1, Additional Ambernath – MIDC, Ambernath (East),District Thane, 421 0506 – Maharashtra, IndiaIndia12/06/2018Non Beta lactamNon Beta lactam • Tablets (Coated and Uncoated) • Hard gelatin shell CapsulesNon Beta lactam • Tablets (Coated and Uncoated) • Hard gelatin shell CapsulesNoneCompliantDenis Mwesigwa
153IRF/F/432/11/2018 071/GMP/2019 GMP Cert No.Ipanema Industria De Produtos Veterinarios LtdaRaposo Tavares Road, Km 113-Aracoiaba da Serra city/Sao Paulo, Brazil.Brazil05/10/2018Non Beta LactamNon Beta Lactam: • External Liquid (ectoparasiticide)Non Beta Lactam: • External Liquid (ectoparasiticide)None26th November 2018 Report dateCompliantMutyaba Michael
154IRF/F/137/11/2017- R6 048/GMP/2018IPCA Laboratories LimitedPlot No. 225/1, Village Athal, Silvassa-396230, Union Territory of Dadra & Nagar Haveli, India.India24/10/201724/10/2020Non Beta Lactam• Tablets (coated and uncoated) • Capsules hard gelatin.• Tablets (coated and uncoated) • Capsules hard gelatin.None07/03/2018CompliantKenneth Kiiza
155IRF/F/190/01/2018- R8 084/GMP/2018IPCA Laboratories LtdPlot No. T-139, MIDC, industrial estate, Tarapur, Boisor, Dist- Palghar, Thane 401506, Maharashtra. India.India19/12/201719/12/2020Non-Beta lactamNon-Beta lactam • Coated & uncoated tabletsNon-Beta lactam • Coated & uncoated tabletsNone 31/01/2018 Report dateCAPA SUBMITTEDCompliantMutyaba Michael
156IRF/F/154/12/2017- R6 047/GMP/2018Ivee Infusions EPZ LtdAthii River Export Processing Zone, LR No. 18474/84, Athii River P O Box 25251, Nairobi 00100, KenyaKenya17/11/201717/11/2020Non-beta lactam• Small Volume Parenterals (Solutions) • Large Volume Parenterals (Solutions) • Sterile Eye, Ear and Nasal Drops• Small Volume Parenterals (Solutions) • Large Volume Parenterals (Solutions) • Sterile Eye, Ear and Nasal DropsNone27/02/2018 CAPA SubmittedCompliantMutyaba Michael
157IRF/F/314/06/2018 R10 090/GMP/2018Jamjoom Pharmaceutical CompanyPlot no. ME1:3 phase 5, industrial city, P.O.Box 6267, Jeddah, 21442 Kingdom of Saudi ArabiaSaudi Arabia26/04/201826/04/2021Non-beta lactamNon-beta lactam Tablets Hard gelatin capsules Soft gelatin capsules Oral powder Oral liquids Semisolids (Ointments, creams, Gels) SVP ampoules Ophthalmic preparationsNon-beta lactam Tablets Hard gelatin capsules Soft gelatin capsules Oral powder Oral liquids Semisolids (Ointments, creams, Gels) SVP ampoules Ophthalmic preparationsNone08th June 2018 Report dateCompliantZaid Mwonda
158IRF/F/102/07/2019 127/GMP/2019 Cert No.JB Chemicals and Pharmaceuticals Limited128/1, GIDC Industrial Estate, Ankleshwar- 393002, Bharuch district, Gujarat, IndiaIndia26/04/201926/04/2022Non ?-lactamNon ?-lactam: Tablets, Oral liquids (Suspensions and syrups), Capsules (Hard gelatin)Non ?-lactam: Tablets, Oral liquids (Suspensions and syrups), Capsules (Hard gelatin)None10th July 2019 Report dateCompliantNasser Lubowa
159IRF/F/331/05/2018 R10 171/GMP/2018 GMP Cert No.Johnson & Johnson (Pty) Ltd241 Main Road, Retreat, 7945, Cape Town, South AfricaSouth Africa24/04/201824/04/2021Non Beta-lactamNon Beta-lactam • Tablets (uncoated) • Liquids for internal use • Liquids for external use (Mouth wash)Non Beta-lactam • Tablets (uncoated) • Liquids for internal use • Liquids for external use (Mouth wash)None10/10/2018 CAPA SUBMITTEDCompliantNambasa Victoria
160IRF/F/316/06/2018 R10 091/GMP/2018Jordanian Pharmaceutical Manufacturing CompanyAl-Razi Site, Um Al—Amad, JordanJordan07/04/201807/04/2021Non-Beta lactamNon-Beta lactam • Tablets • Hard Gelatin Capsules • Oral LiquidsNon-Beta lactam • Tablets • Hard Gelatin Capsules • Oral LiquidsNone06/11/2018 CAPA SUBMITTEDCompliantZaid Mwonda
161IRF/L/019/02/2019 122/GMP/2019 Cert No.Kampala Pharmaceutical Industries (1996) LimitedStretcher Road, Plot M444B, Ntinda, KampalaUganda20/12/201820/12/2021Non- 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 •AquasafeNone08th February 2019 Report DateCompliantSsali Peter
162IRF/F/377/09/2018 R12 053/GMP/2019 GMP Cert No.Karnataka Antibiotics and Pharmaceuticals LtdPlot 14 Phase II Peenya Industrial Area Bangalore -560058India31/07/2018Beta lactam Penicillin Beta lactam Cephalosporin Non Beta lactamBeta lactam Penicillin • Dry powders for Injection Beta lactam Cephalosporin • Dry powders for Injection Non Beta lactam • Dry powders for injectionBeta lactam Penicillin • Dry powders for Injection Beta lactam Cephalosporin • Dry powders for Injection Non Beta lactam • Dry powders for injectionNone21/11/2018 CAPA SUBMITTEDCompliantOkello Andrew
163079/GMP/2019 DRKela N.V.Sint Lenaartseweg 48, 2320 Hoogstragten, Belgium.Belgium22/05/201922/05/2022Non-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 LiquidsNoneCompliantKaleebu Frank
164IRF/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 IndiaIndia23/04/201923/04/2022Non ?-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)None10th July 2019 Report dateCompliantNasser Lubowa
165IRF/F/217/04/2018 R10 149/GMP/2018Kinhoo Pharmaceuticals Co., LtdBio-industry Zone, Golden Coast, Zhuhai, Guangdong, 519041, ChinaChina20/03/201820/03/2021Beta lactam (Cephalosporins) Non Beta-lactamBeta lactam (Cephalosporins) • Tablets • Powders/Granules for oral suspensions. • Sterile Small Volume Parenteral powders Non Beta-lactam • Tablets • Powders/Granules for oral suspensions. • Hard gelatin capsules • Soft gelatin capsules (Herbal)Beta lactam (Cephalosporins) • Tablets • Powders/Granules for oral suspensions. • Sterile Small Volume Parenteral powders Non Beta-lactam • Tablets • Powders/Granules for oral suspensions. • Hard gelatin capsules • Soft gelatin capsules (Herbal)None20/07/2018 CAPA SUBMISSIONCompliantEtuko Daniel
166IRF/F/393/09/2018 R12 131/GMP/2019 Cert No.Komipharm International Co.Ltd17, GyeongJe-Ro, Sihueng-si, Gyeonggi-Do, South KoreaKorea, Republic of (South)07/08/201807/08/2021Non Beta Lactam (veterinary use)Non Beta Lactam (veterinary use) • VaccinesNon Beta Lactam (veterinary use) • VaccinesNone28th September 2018 REPORT DATE, CAPA submitted 31/12/18CompliantOnen Solomon L.
167IRF/F/020/02/2019 120/GMP/2019 Cert No.Kremoint Pharma Pvt LtdB-8, Additional MIDC, Ambernath East, Dist. Thane, Maharashtra, India.India27/11/201827/11/2021Non-Beta LactamNon-Beta Lactam • External semi-solids (creams, gels and ointments)Non-Beta Lactam • External semi-solids (creams, gels and ointments)None11th February 2019 Report DateCompliantAtumanya Amos
168082/GMP/2019 DRLabesfal Laboratorios Almiro S.A.Zona Industrial Do Lagedo, 3465-157 Santigo De Besteiros, Tondel, PortugalPortugal23/05/201923/05/2022Non-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)NoneCompliantKaleebu Frank
169IRF/F/028/02/2019 090/GMP/2019 Cert No.Laborate Pharmaceutical India Limited Unit II31, Rajban Road, Nariwala, Paonta Sahib, Distt, Sirmour, Himachal Pradesh India.India04/12/201804/12/2021Non-beta LactamNon-beta Lactam: • Aseptically filled SVP liquids • Aseptically filled Ophthalmic solutions • Tablets (coated & uncoated) • Hard gelatin capsules • Liquids for internal useNon-beta Lactam: • Aseptically filled SVP liquids • Aseptically filled Ophthalmic solutions • Tablets (coated & uncoated) • Hard gelatin capsules • Liquids for internal useNone14th February 2019 Report DateCompliantAtumanya Amos
170069/GMP/2019 DRLaboratoies Besins International13 rue Perier BP 41, 92122 Montrouge Cedex - FranceFrance04/04/201904/04/2022Non-Beta Lactam hormonesNon-Beta Lactam hormones: Semi-solid gelsNon-Beta Lactam hormones: Semi-solid gelsNoneCompliantKaleebu Frank
171IRF/F/328/06/2018 R10 103/GMP/2018Laboratorio Pablo Cassara S.R.LCarthue 1096 c 1408 GBV Buenos Aires (Production site 4, Dr. Jose de la Rosa street between Avenida General Paz and Saladillo 1440 Buenos Aires)Argentina04/05/201804/05/2021Non beta lactam;Aerosols (Metered Dose Inhalers)Aerosols (Metered Dose Inhalers)None22nd June 2018 Report dateCompliantNasser Lubowa
172IRF/F/434/11/2018 064/GMP/2019 GMP Cert No.Laboratorios Hipra S.AAvda la Selva, 135 17170 Amer, Girona, SpainSpain23/10/2018Vaccines Non Beta Lactam Beta LactamVaccines: Live attenuated bacterial and Viral vaccines in SVP vials Inactivated bacterial and viral vaccines in SVP vials Non Beta Lactam: Oral liquids Injectable Liquids Beta Lactam: Injectable LiquidsVaccines: Live attenuated bacterial and Viral vaccines in SVP vials Inactivated bacterial and viral vaccines in SVP vials Non Beta Lactam: Oral liquids Injectable Liquids Beta Lactam: Injectable LiquidsNone30th November 2018 Report dateCompliantLukwago Mohammad
173IRF/F/440/12/2018 212/GMP/2018 GMP Cert No.Laboratorios Inibsa, S.ACarretera de Sabadell a Granollers, Llica de Vall, 08185 Barcelona, SpainSpain19/10/2018Non-beta lactamNon-beta lactam: • Small volume parenteral solution (Pre-filled Dental cartridges) aseptically filledNon-beta lactam: • Small volume parenteral solution (Pre-filled Dental cartridges) aseptically filledNone28/12/2018 Report DateCompliantKeneth Kiiza
174IRF/F/337/06/2018 R10 105/GMP/2018Laurus Labs Ltd (Unit 2)Plot No. 19, 20 & 21 Western sector, APSEZ, Atchutapuram, 531011, Visakhaptnam, Andra Pradesh, India.India24/04/2018Non-Beta LactamNon-Beta Lactam • Hard Gelatin Capsules • Tablets coated and uncoatedNon-Beta Lactam • Hard Gelatin Capsules • Tablets coated and uncoatedNone29th June 2018 Report DateCompliantAnnet Ssekindu
175IRF/F/153/12/2017- R7 201/GMP/2018 GMP Cert No.Leben Laboratories Pvt LimitedPlot L-4, Phase III, MIDC Akola-444104, Maharashtra, IndiaIndia03/10/201703/10/2020Non-beta lactam Beta-lactam (Penicillin and Cephalosporin)Non-beta lactam • Tablets • Capsules (Hard gelatin capsules) • Oral Liquids • External Preparations (Ointments, Creams, Lotions) Beta-lactam (Penicillin and Cephalosporin) • Tablets • Capsules (Hard gelatin capsules) • Dry syrupNon-beta lactam • Tablets • Capsules (Hard gelatin capsules) • Oral Liquids • External Preparations (Ointments, Creams, Lotions) Beta-lactam (Penicillin and Cephalosporin) • Tablets • Capsules (Hard gelatin capsules) • Dry syrupNone21/03/2018 CAPA SubmittedCompliantMuhammad I. Lukwago
176025/GMP/2019Lilly Del Caribe, Inc12.6 KM 65TH Infantry Road (PR01), CAROLINA, Puerto Rico 00985, Puerto RicoUnited States Of America30/01/201930/01/2022Non-Beta LactamNon-Beta Lactam: Tablets (Bulk manufacturing)Non-Beta Lactam: Tablets (Bulk manufacturing)NoneCompliant
177138/GMP/2018 DRLilly FranceFegersheim, Za Center De Production, 2 Rue Du Colonel Lilly, Fegersheim, 67640, FranceFrance07/09/201807/09/2021BiologicalSmall Volume Parenteral (Insulin)Small Volume Parenteral (Insulin)NoneCompliantDenis Mwesigwa
178168/GMP/2018 DRLilly S.ALilly SA, Avda. Industria 30, 28108, Alcobendas, Madrid Spain.Spain29/10/201829/10/2021Non-Beta LactamNon-Beta Lactam TabletsNon-Beta Lactam TabletsNoneCompliantKaleebu Frank
179IRF/F/033/03/2017 - Q7 143/GMP/2017Lincoln Parenterals Ltd11, Trimul Estate, near Khatraj Chokadi, P.O. Box Khatraj-382721, Ghandinagar, Gujarat - IndiaIndia12/12/201712/12/2020NBLSVP Solutions SVP Powders Oral liquidsSVP Solutions SVP Powders Oral liquidsNoneCompliantPeter Ssali
180IRF/F/125/11/2017-R5Liptis Egypt for Pharmaceuticals and Medical Products, SAEPlot No. 2/B, 6th Industrial Zone, 6th of October City, EgyptEgypt03/10/201703/10/2020NBL• Coated and Uncoated Tablets • Hard Gelatin Capsules • Powder for Oral Suspension• Coated and Uncoated Tablets • Hard Gelatin Capsules • Powder for Oral SuspensionNoneCompliantNasser Lubowa
181IRF/F/425/11/2018 174/GMP/2018 GMP Cert No.Lupin Limited - AuragabandA-28/1, M.I.D.C, Chikalthana, Aurangabad-431210, Maharashtra, India.India21/09/2018Non-beta lactam linesNon-beta lactam lines: Tablets Hard gelatin capsules Tablets Hard gelatin capsules Liquids for internal use (syrups and suspensions)Non-beta lactam lines: Tablets Hard gelatin capsules Tablets Hard gelatin capsules Liquids for internal use (syrups and suspensions)None07th November 2018 Report dateCompliantKaleebu Frank
182IRF/F/423/11/2018 162/GMP/2018 GMP Cert No.Lupin Limited (Nagpur)Plot No. 6A, sector 17, Special economic zone, Mihan, Nagpur 441108, Maharashstra, India. (Block 1).India18/09/2018Non-beta lactamNon-beta lactam; • Tablets (coated and uncoated)Non-beta lactam; • Tablets (coated and uncoated)None01st November 2018 Report DateCompliantKaleebu Frank
183IRF/F/407/10/2018 GMP Cert No. 031/GMP/2019M.J Biopharm Pvt LtdL7,MIDC Industrial Area, Taloja Dist. Raigad 410208, IndiaIndia24/08/2018Non beta lactam Beta lactam (Cephalosporin & Penem)Non beta lactam. • Coated and uncoated Tablets, • Hard gelatin capsules, • Small volume parenteral solutions (ampoules, cartridges, vials and pre-filled syringes), Beta lactam (Cephalosporin & Penem) • Dry powder for injection (Vials)Non beta lactam. • Coated and uncoated Tablets, • Hard gelatin capsules, • Small volume parenteral solutions (ampoules, cartridges, vials and pre-filled syringes), Beta lactam (Cephalosporin & Penem) • Dry powder for injection (Vials)None12th October 2018 REPORT DATECompliantVictoria Kwesiga
184IRF/F/326/06/2018 R10 101/GMP/2018mAbxience S.A.UCarlos Village 5148 Munro, Buenos Aires B16054XL Argentina.Argentina08/05/201808/05/2021Biopharmaceutical lineInjectable Recombinant Monoclonal Antibodies (Bulk APIs)Injectable Recombinant Monoclonal Antibodies (Bulk APIs)None22nd June 2018 Report dateCompliantNasser Lubowa
185088/GMP/2018 DRMacarthys Laboratories Limited T\A Martindale PharmaBampton Road, Romford, Essex RM3 8UG, UKUnited Kingdom06/06/201806/06/2021Non Beta LactamSmall Volume Parenterals (Liquids)Small Volume Parenterals (Liquids)None06th June 2018 Report DateCompliantDenis Mwesigwa
186IRF/F/048/03/2019 GMP Cert No. 060/GMP/2019Macleods Pharmaceuticals Ltd, Unit IIPlot No. 25-27, Survey No. 366, Premier Industrial Estate, Kuchigam, Daman – 396 210 (U.T) IndiaIndia30/11/2018Non-Beta LactamNon-Beta Lactam: • Tablets (coated and uncoated) • Hard Gelatin Capsules • SVP – Powder vialsNon-Beta Lactam: • Tablets (coated and uncoated) • Hard Gelatin Capsules • SVP – Powder vialsNone19th March 2019 Report DateCompliantOkello Andrew
187IRF/F/439/12/2018 049/GMP/2019 GMP Cert No.Malik Lifesciences Pvt. LtdPlot No.: 16, Vardhman Industrial Estate, Village Bahadarpur Saini, NH-58 Roorkee- 247667, Haridwar, Uttarakhand, IndiaIndia26/09/2018Penicillin CephalosporinPenicillin • Tablets (coated and uncoated) • Hard gelatin capsules • Powders for oral suspension (dry syrups) Cephalosporin • Tablets (coated and uncoated) • Powders for oral suspension (dry syrups)Penicillin • Tablets (coated and uncoated) • Hard gelatin capsules • Powders for oral suspension (dry syrups) Cephalosporin • Tablets (coated and uncoated) • Powders for oral suspension (dry syrups)None21/12/2018 Report DateCompliantSsali Peter
188IRF/F/386/09/2018 R12 206/GMP/2018 GMP Cert No.Maneesh Exports (EOU)Plot D-16/7, TTC Industrial Area, MIDC Turbhe, Navi Mumbai – 400 703, Dist. Thane, Maharashtra, IndiaIndia19/07/201819/07/2021Beta Lactam (Penicillin)Beta Lactam (Penicillin) • Tablets (coated and uncoated) • Hard Gelatin Capsules • Dry Powders for Oral Suspension • Small Volume Parenterals- Dry Powders for Injection in VialsBeta Lactam (Penicillin) • Tablets (coated and uncoated) • Hard Gelatin Capsules • Dry Powders for Oral Suspension • Small Volume Parenterals- Dry Powders for Injection in VialsNoneCAPA SubmittedCompliantNasser Lubowa
189IRF/F/360/08/2018 R12 012/GMP/2019 GMP Cert No.Marcyrl Pharmaceuticals IndustriesEl Obour City, Western Extension Parts No. 5-12, Block 20005Egypt05/07/201805/07/2021Non Beta lactamNon Beta lactam • Tablets (coated and uncoated) • Capsules hard gelatin • Capsules soft gelatin • Oral powders (sachets) • Suppositories Hormonal • Creams, Ointments and gelsNon Beta lactam • Tablets (coated and uncoated) • Capsules hard gelatin • Capsules soft gelatin • Oral powders (sachets) • Suppositories Hormonal • Creams, Ointments and gelsNone11/10/2018 CAPA SUBMITTEDCompliantKenneth Kiiza
190IRF/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, EgyptEgypt30/04/201930/04/2022Biological productsBiological products: Small Volume Parenteral liquids (in vials) – aseptically preparedBiological products: Small Volume Parenteral liquids (in vials) – aseptically preparedNone05th July 2019 Report DateCompliantLukwago Mohammad
191IRF/F/013/02/2019 108/GMP/2019 Cert No.Medicamen Organics LtdPlot No. 60, sector -6a, IIE, Sidcul, Ranipur, Haridwar, Uttarakhand, IndiaIndia20/11/201820/11/2021Non-Beta LactamNon-Beta Lactam • Tablets (coated and uncoated)Non-Beta Lactam • Tablets (coated and uncoated)None01st February 2019 Report DateCompliantAtumanya Amos
192IRF/F/350/08/2018 R11 034/GMP/2019 GMP Cert NoMedico Remedies LtdPlot 8 & 9, Dewan & Sons Udyog Nagar, Lokmanya NagarPalghar (West), District Palghar 401 404, Maharashtra, India.India19/06/2018Non Beta Lactam Beta Lactam (Penicillin) Beta Lactam (Cephalosporin)Non Beta Lactam • Tablets (coated and Uncoated) • Hard Gelatin Capsules Beta Lactam (Penicillin) • Dry powder for Oral suspension • Hard Gelatin Capsules Beta Lactam (Cephalosporin): • Tablets (Coated and Uncoated) • Hard Gelatin CapsulesNon Beta Lactam • Tablets (coated and Uncoated) • Hard Gelatin Capsules Beta Lactam (Penicillin) • Dry powder for Oral suspension • Hard Gelatin Capsules Beta Lactam (Cephalosporin): • Tablets (Coated and Uncoated) • Hard Gelatin CapsulesNone11/10/2018 CAPA SUBMITTEDCompliantDenis Mwesigwa
193IRF/F/044/02/2019 055/GMP/2019 GMP Cert No.Medispray Laboratories Pvt Limited, Unit II346-348 Kundaim Industrial Estate, Kundaim Goa-403115 IndiaIndia11/12/2018?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)None21st February 2019 Report DateCompliantZaid Mwonda
194IRF/F/408/10/2018 GMP Cert No. 033/GMP/2019Medley Pharmaceuticals LtdLane 03, Phase I, SIDCO Industrial Complex, Bari Brahmana Jammu 181133India31/08/2018Non Beta lactamNon Beta lactam: • Tablets (Coated and uncoated) • Hard gelatin capsules • Oral liquids (syrup & suspension)Non Beta lactam: • Tablets (Coated and uncoated) • Hard gelatin capsules • Oral liquids (syrup & suspension)Non Beta lactam: • Tablets (Coated and uncoated) • Hard gelatin capsules • Oral liquids (syrup & suspension)04/12/2018 CAPA SUBMITTEDCompliantVictoria Kwesiga
195IRF/F/325/06/2018 R10 184/GMP/2018 GMP Cert NoMEDMAC for Manufacturing Agricultural Chemicals & Veterinary Products LTDAl Hussun St. opposite Al-Asser suite Company, Al Rumtha /Al Hassan Industrial City, Jordan.Jordan03/04/201803/04/2021Non Beta lactamNon Beta Lactam Water Soluble Powders for Oral Solutions Oral liquids Small Volume Parenteral Solutions (Secondary packaging and release)Non Beta Lactam Water Soluble Powders for Oral Solutions Oral liquids Small Volume Parenteral Solutions (Secondary packaging and release)NoneCAPA SubmittedCompliantZaid Mwonda
196IRF/F/070/05/2019 149/GMP/2019 GMP Cert No.Medopharm Private Limited Laboratories50,Kayarembedu Village,Guduvanchery 603 202 Tamil Nadu- IndiaIndia05/02/201905/02/2022Non-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 suspensionNone10th May 2019 GMP Report DateCompliantWilberforce Kwiringira
197IRF/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, IndiaIndia05/04/2019Beta-lactam (Penicillin)Beta-lactam (Penicillin): Tablet, Hard Gelatine Capsules, Powder for oral suspensionBeta-lactam (Penicillin): Tablet, Hard Gelatine Capsules, Powder for oral suspensionNone08th July 2019 Report dateCompliantZaidi Mwondha
198IRF/F/358/08/2018 R12 112/GMP/2019 Cert No.Memphis company for pharmaceutical and chemical industriesPlot No. 8 EI Sawah Al-ameria Cairo, Egypt.Egypt16/07/201816/07/2021Non ?-lactamNon ?-lactam • Tablets coated and uncoated • Capsules (Hard gelatin) • Oral liquids • Creams and ointment • SVP Injection solutions (in Ampoules and Vials)Non ?-lactam • Tablets coated and uncoated • Capsules (Hard gelatin) • Oral liquids • Creams and ointment • SVP Injection solutions (in Ampoules and Vials)None27th August 2018 Report DateCompliantKenneth Kiiza
199200/GMP/2018 DRMerck KGaAFrankfurter Strasse 250; D-64293 Darmstadt, GermanyGermany30/11/2018Non-Beta LactamNon-Beta Lactam Tablets Small Volume ParenteralsNon-Beta Lactam Tablets Small Volume ParenteralsNoneCompliantKaleebu Frank
200190/GMP/2017- DRMerck Sante s.a.sCentre De Production, 2 Rue du Pressoir Vert, 45400 Semoy-France30/11/2017Non Beta lactamTabletsTabletsNoneCompliantNasser Lubowa
201028/GMP/2019 DRMerck Serono S.P.AVia Luigi Einaudi 11, 1-00012 Gudonia, Montecelio - ItalyItaly31/01/201931/01/2022Quality 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 / releaseNoneCompliant
202174/GMP/2017 - DRMerck Serono SPA (Bari)Via Delle MAgnolie, 15 (Loc Fraz Zona Industriale) 70026, Modugno, BariItaly08/11/201708/11/2020Hormones and Terminally sterilized products- Hormones & substances with hormonal activity (SVP - Syringes & cartridges, Lyophilised powders) - Terminally sterilized products (SVP)- Hormones & substances with hormonal activity (SVP - Syringes & cartridges, Lyophilised powders) - Terminally sterilized products (SVP)NoneCompliantMwesigwa Denis
203174/GMP/2017-DRMerck Serono SPA (Bari)Via Delle Magnolie 15 (Loc Fraz Zona Industriale) 70026, Modugno, BariItaly08/11/2017HormonesSVP - syringes & cartridges and Lyophilized powders (Hormones & subtances with hormonal activity) SVP (Terminally sterilised)SVP - syringes & cartridges and Lyophilized powders (Hormones & subtances with hormonal activity) SVP (Terminally sterilised)NoneCompliantMwesigwa Denis
204IRF/F/311/05/2018 R10 072/GMP/2018Merck Sharp & Dohme B.VWaarderweg 39, 2031 BN Haarlem, P.O Box 581, 2003 PC Haarlem, Netherlands.Netherlands10/04/201810/04/2021Non beta lactam;Non beta lactam; • Tablets (Primary and secondary packaging) • Oral liquids (Secondary packaging)Non beta lactam; • Tablets (Primary and secondary packaging) • Oral liquids (Secondary packaging)None14th May 2018 Report DateCompliantOkello Andrew
205169/GMP/2017 - DRMerckle GmbH (A member of ratiopharm Group)Ludwig Merckle Str. 3, 89143 Blaubeuren WeilerGermany08/11/201708/11/2020NBLInjection SVP Hard Gelatin Capsules Gels Nasal spraysInjection SVP Hard Gelatin Capsules Gels Nasal spraysNoneCompliantMwesigwa Denis
206IRF/F/355/08/2018 R12 128/GMP/2018Merial4 Chemin du Calquet 31000 Toulouse FranceFrance27/07/2018Non-beta lactam:NBL Topical solutions (Ectoparasiticides) Injectable powder in sachets (Isometamidium powder for injection- Trypamidium) Solutions for injection (Aseptically filled and terminally sterilized small volume parenterals and large volume parenterals)NBL Topical solutions (Ectoparasiticides) Injectable powder in sachets (Isometamidium powder for injection- Trypamidium) Solutions for injection (Aseptically filled and terminally sterilized small volume parenterals and large volume parenterals)None27th August 2018 Report DateCompliantKaleebu Frank
207IRF/F/206/02/2018 R9 058/GMP/2018Merial SASRue de l” Aviation-69800 Saint- Priest, Lyon France.France15/10/201715/10/2020Veterinary vaccines NBLVeterinary vaccines ; • Small volume parenterals (solutions and lyophilized) • Tablets.Veterinary vaccines ; • Small volume parenterals (solutions and lyophilized) • Tablets.None 21/02/2018 Report Date23/4/2018 CAPA SUBMITTEDCompliantOnen Solomon L.
208IRF/F/413/10/2018 015/GMP/2019 GMP Cert No.Meridian Enterprises Pvt LtdPlot 418 GIDC, Kabilpore, Navsari, Gujarat- IndiaIndia24/08/201824/08/2021Non-beta lactamNon-beta lactam: • Suppositories • Tablets (coated and uncoated) • Liquids for external use (Nasal preparations, and disinfectants)Non-beta lactam: • Suppositories • Tablets (coated and uncoated) • Liquids for external use (Nasal preparations, and disinfectants)NoneCAPA SubmittedCompliantDennis Mwesigwa
209IRF/F/129/11/2017- R5 064/GMP/2018Micro Labs LimitedPlot 121-124 K.I.A.D.B, Bommasandra, 4th Phase Anekal Taluk, Bangalore 560099, Karnataka- INDIAIndia24/10/201724/10/2020Cephalosporin beta lactam:• Tablets (coated and uncoated) • Hard gelatin capsules • Dry powder for oral suspension • Sterile SVP powders• Tablets (coated and uncoated) • Hard gelatin capsules • Dry powder for oral suspension • Sterile SVP powdersNone Report sent on 17 Nov 201716/06/2018 CAPA SUBMITTEDCompliantNsereko Henry
210IRF/F/427/11/2018 186/GMP/2018 GMP Cert No.Micro Labs LimitedPlot No.: S-155 to S-159 & N1, Phase III to IV, Verna Industrial Estate, Verna, Salcette, Goa – 403722, IndiaIndia11/09/2018Non-beta oral solid dosageNon-beta oral solid dosage; • Tablets (coated and uncoated) • Hard gelatin capsulesNon-beta oral solid dosage; • Tablets (coated and uncoated) • Hard gelatin capsulesNone23rd October, 2018 Report dateCompliantSsali Peter
211IRF/F/427/11/2018 186/GMP/2018 GMP Cert No.Micro Labs LimitedPlot No.: S-155 to S-159 & N1, Phase III to IV, Verna Industrial Estate, Verna, Salcette, Goa – 403722, IndiaIndia11/09/2018Non-beta oral solid dosageNon-beta oral solid dosage Tablets (coated and uncoated) Hard gelatin capsulesNon-beta oral solid dosage Tablets (coated and uncoated) Hard gelatin capsulesNone23rd November 2018 GMP Report dateCompliantSsali Peter
212IRF/F/310/05/2018 R10 071/GMP/2018Millmount Healthcare LtdMillmount Healthcare Ltd Block 7, City North Business Campus, Stamullen County, Meath, Ireland.Ireland17/04/201817/04/2021Non Beta Lactam• Secondary packaging of tablet and hard gelatin Capsules.Secondary packaging of tablet and hard gelatin Capsules.None14th May 2018 Report DateCompliantOkello Andrew
213IRF/F/105/07/2019 GMP Cert No. 025/GMP/2020Minapharm PharmaceuticalsMina Street, 03rd Industrial zone A2-10th of Ramadhan City, EgyptEgypt15/04/201915/04/2022Non-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)None15th July 2019 Report dateCompliantLukwago Mohammad
214143/GMP/2018 DRMipharm S.p.AVia B. Quaranta 12 – 20141, Milano ItalyItaly08/08/201808/08/2021Non Beta LactamPowder for oral suspensionPowder for oral suspensionNoneCompliantDenis Mwesigwa
215IRF/F/317/06/2018 R10 092/GMP/2018MS pharma - JordanPlot no. 356, Street no. 6, King Abdullah II Bin Al- Hussein Industrial Estate, South- Western Edge Sahab zone.Jordan12/04/201812/04/2021Non-Beta lactamNon-Beta lactam SVP solutions & Lyophilizates. LVP solutions (bags).Non-Beta lactam SVP solutions & Lyophilizates. LVP solutions (bags).None08th June 2018 Report dateCompliantZaid Mwonda
216IRF/F/164/01/2018- R7 004/GMP/2018 GMP CERTMSN Laboratories (Pvt) Ltd-Formulations DivisionPlot No. 42, Anrich Industrial Estate, Bollaram, Sanagareddy District- 502-325-Telengana, IndiaIndia10/11/201710/11/2020Non beta lactamTablets (coated and uncoated) Hard gelatin capsules Small volume parenteral solutions in Ampoule and vials Small volume parenteral lyophilized powders in vials OncologyTablets (coated and uncoated) Hard gelatin capsules Small volume parenteral solutions in Ampoule and vials Small volume parenteral lyophilized powders in vials OncologyNone08/01/2018 Gmp Cert dateCompliantVictoria Kwesiga
217IRF/F/072/05/2019 150/GMP/2019 Cert No.Mylan Laboratories LimitedPlot No. 1606-1609, GIDC, sarigam, Tal - Umergam, Dist Valsad-396155, IndiaIndia01/02/201901/02/2022Non ?-lactamNon ?-lactam: • Coated & Uncoated Tablets (Oral contraceptives, placebos and ferrous fumarate)Non ?-lactam: • Coated & Uncoated Tablets (Oral contraceptives, placebos and ferrous fumarate)None10th May 2019 GMP Report DateCompliantWilberforce Kwiringira
218IRF/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, IndiaIndia29/03/2019Beta-lactam (Penicillin)Beta-lactam (Penicillin): Powder for injectionBeta-lactam (Penicillin): Powder for injectionNone10th July 2019 Report dateCompliantZaidi Mwondha
219IRF/F/130/11/2017- R5Mylan Laboratories Limited-AurangabadH-12 and H-13, MIDC, Waluj Industrial Area Aurangabad- 431 136 Maharashtra, IndiaIndia17/10/201717/10/2020Non Beta Lactam• Tablets (coated and uncoated) • Hard gelatin capsules• Tablets (coated and uncoated) • Hard gelatin capsulesNoneCompliantNsereko Henry
220IRF/F/334/06/2018 R10 104/GMP/2018Mylan Laboratories LtdPlot No.11, 12 & 13, Indore Special Economic Zone, Pharma zone, phase II, sector III, Pithampur -454775; Dist; Dhar; Madhya Pradesh; India.India08/05/201808/05/2021Non-Beta LactamNon-Beta Lactam • Tablets coated and uncoatedNon-Beta Lactam • Tablets coated and uncoatedNone29th June 2018 Report DateCompliantAnnet Ssekindu
221IRF/F/364/08/2018 R12 130/GMP/2018Mylan Laboratories LtdF/4 & F/12 MIDC Malegaon, Sinnar Nashik -422 113, IndiaIndia03/08/2018Non beta-lactam.Non beta-lactam. • Tablets • Capsules (Hard Gelatin)Non beta-lactam. • Tablets • Capsules (Hard Gelatin)NONE31st August 2018 REPORT DATECompliantZaid Mwonda
222IRF/F/402/09/2018 R12 153/GMP/2018 GMP CERT NoMylan Laboratories LtdPlot no. S-16& S-17/A SEG Green Industrial Park Paepally (V) Jadchelra Telangana District- 509302 IndiaIndia07/08/2018Non-beta lactamNon-beta lactam • Hard gelatin Capsules • TabletsNon-beta lactam; • Hard gelatin Capsules • TabletsNone28th September, 2018 REPORT DATECompliantZaid Mwonda
223IRF/F/368/09/2018 R12 004/GMP/2019 GMP Cert No.Nabros Pharma Pvt LtdSurvey No. 110/A/2, Amit Farm Jain Upasraya, near Cocacola Factory, NH No. 8, Kajipura, Dist. Kheda-387411, Gujarat, IndiaIndia24/07/201824/07/2021Non Beta lactamNon Beta lactam: • Tablets (coated and uncoated) • Hard gelatin capsules • Powders in sachets • Small volume parenteral and Ophthalmic preparations • External Preparations (gels)Non Beta lactam: • Tablets (coated and uncoated) • Hard gelatin capsules • Powders in sachets • Small volume parenteral and Ophthalmic preparations • External Preparations (gels)None21/11/2018 CAPA SUBMITTEDCompliantAtumanya Amos
224IRF/F/150/12/2017- R6 056/GMP/2018NANJING BAIJINGYU PHARMACEUTICAL CO. LTDNo. 1 Huizhong Road, Nanjing Economic and Technical Development Zone. ChinaChina03/11/201703/11/2020Non-beta-lactam1. Non Hormonal Tablets (coated and uncoated) 2. Hormonal Tablets (coated and uncoated)1. Non Hormonal Tablets (coated and uncoated) 2. Hormonal Tablets (coated and uncoated)None05/04/2018CompliantAkali Alfred
225IRF/F/348/07/2018 R11 007/GMP/2019 GMP Cert No.NanoAlvand Co. LtdNo 1462, Avicenna tech park of Tehran University of Medical Sciences, North Kargar Ave, Tehran –IranIran27/05/201827/05/2021Non Beta-lactam (Oncology):Non Beta-lactam (Oncology): • Small Volume Parenteral Injections liquids (in vials) • Small Volume Parenteral (lyophilised powders) for Injections (in vials)Non Beta-lactam (Oncology): • Small Volume Parenteral Injections liquids (in vials) • Small Volume Parenteral (lyophilised powders) for Injections (in vials)NoneCAPA SubmittedCompliantEtuko Daniel
226IRF/F/300/04/2018 R10 112/GMP/2018Naprod Life Sciences Pvt. LtdG-17/1, MIDC Tarapur Ind. Area, Boisar, 401506 Maharashtra India.India02/03/201802/03/2021Non-Beta Lactam Preparations (General and Oncology):General Block 1-SVP Liquids 2-SVP Lyophilized products Oncology (Onex II) 1-Tablets (Coated and Uncoated) 2-Hard Gelatin Capsules 3-SVP Liquids 4-SVP Lyophilized products 5-GranulesGeneral Block 1-SVP Liquids 2-SVP Lyophilized products Oncology (Onex II) 1-Tablets (Coated and Uncoated) 2-Hard Gelatin Capsules 3-SVP Liquids 4-SVP Lyophilized products 5-GranulesNone04/07/2018 CAPA SUBMISSIONCompliantDavid Nahamya
227IRF/F/092/07/2019 146/GMP/2019 Cert No.NATCO Pharma LimitedVijayapuri North, Nagarjuna Sagar, Peddavura Mandal, Nalgonda District- 508 202, Telangana - IndiaIndia07/05/201907/05/2022Beta-Lactam (Penicillin)Beta-Lactam (Penicillin): Aseptically filled sterile dry powder for injection.Beta-Lactam (Penicillin): Aseptically filled sterile dry powder for injection.None05th July 2019 Report DateCompliantVictoria Kwesiga
228IRF/F/131/11/2017- R5 117/GMP/2018National Healthcare PVT ltdChhatapipra-3, Bara, NepalNepal10/10/201710/10/2020Non-beta lactam, Beta lactam CephalosporinNBL; Tabs,Oral liq,Ext liq,caps,Ointment & creams,SVPs,Eye/Ear Drops, Lyophilized powder for injection. BL(Pen); Tabs,caps,Dry powders for oral susp,SVP powder BL(Cepha); Tabs, Dry powders for oral susp,SVPNBL; Tabs,Oral liq,Ext liq,caps,Ointment & creams,SVPs,Eye/Ear Drops, Lyophilized powder for injection. BL(Pen); Tabs,caps,Dry powders for oral susp,SVP powder BL(Cepha); Tabs, Dry powders for oral susp,SVPNone31/01/2018 CAPA SUBMISSIONCompliantNsereko Henry
229IRF/F/430/11/2018 187/GMP/2018 GMP Cert No.National Pharmaceutical Industries Company OmanP O Box 120 Postal Code 124, Road no.15 Rusayl Industrial Area, Sultanate of Oman.Oman03/10/2018Non-beta lactam Beta-LactamNon-beta lactam: • Hard gelatin Capsules • Tablets • Oral liquids for human use • ORS Beta-Lactam: • Tablets • Hard gelatin capsules • Dry powders for oral suspensionsNon-beta lactam: • Hard gelatin Capsules • Tablets • Oral liquids for human use • ORS Beta-Lactam: • Tablets • Hard gelatin capsules • Dry powders for oral suspensionsNone26th November 2018 Report dateCompliantZaid Mwonda
230IRF/F/387/09/2018 R12 179/GMP/2018 GMP Cert NoNem Laboratories Pvt. LtdPlot No. 133, Krishna Industrial Estate, Navghar Vasai (East), 401210 Dist. Thane (Zone 3), Maharashtra State, IndiaIndia17/07/201817/07/2021Non Beta LactamNon Beta Lactam • Tablets (coated and uncoated) • Creams and Ointments (External Preparations) • Sterile Ophthalmic OintmentsNon Beta Lactam • Tablets (coated and uncoated) • Creams and Ointments (External Preparations) • Sterile Ophthalmic OintmentsNone15/11/2018 CAPA SubmittedCompliantNasser Lubowa
231IRF/F/191/01/2018- R8 179/GMP/2019 Cert No.Neon Laboratories LtdPlot No. 29-32, 57 & 60, Palghar,Taluka Co-operative estate, Boisar Road, Palghar, District-Thane-401404, Maharashtra, India.India23/12/201723/12/2020Non-Beta lactam CephalosporinNon-Beta lactam Tablets Hard gelatin capsules Small volume parenteral (Liquid injectable, dry powder for injection & Lyophilized powder). Cephalosporin Tablets Hard gelatin capsules Small volume parenteral (Dry powder for injection) Dry syrupNon-Beta lactam Tablets Hard gelatin capsules Small volume parenteral (Liquid injectable, dry powder for injection & Lyophilized powder). Cephalosporin Tablets Hard gelatin capsules Small volume parenteral (Dry powder for injection) Dry syrupNone05/02/2018 Report dateCompliantMutyaba Michael
232IRF/F/367/09/2018 R12 054/GMP/2019 GMP Cert No.Next Wave (India)Rampur Ghat, Road, Paonta Sahib, Distt. Sirmour- 173025, Himachal Pradesh, IndiaIndia27/07/2018Non Beta lactamNon Beta lactam • Tablets (coated and uncoated), • Hard Gelatin Capsules, • Oral Liquids, • Semi-solids (Creams, gels & Ointments)Non Beta lactam • Tablets (coated and uncoated), • Hard Gelatin Capsules, • Oral Liquids, • Semi-solids (Creams, gels & Ointments)NoneCompliantAtumanya Amos
233IRF/F/183/01/2018- R8 107/GMP/2018Nitin Life Sciences Limited.Rampur Road, Paonta Sahib, Sirmour-173025, H.P, IndiaIndia01/12/201701/12/2020Non-beta lactam Beta-lactam (cephalosporin)Non-beta lactam Liquid injectable (SVP) Ear/Eye Drops Beta-lactam (cephalosporin) Dry powder for Injection (SVP)Non-beta lactam Liquid injectable (SVP) Ear/Eye Drops Beta-lactam (cephalosporin) Dry powder for Injection (SVP)None11/06/2018 CAPA SUBMITTEDCompliantDennis Mwesigwa
234IRF/F/382/09/2018 R12 057/GMP/2019 GMP Cert No.Nkunzi Pharmaceuticals (PTY) Ltd259 Davidson Road, Cnr Peddie Street, Wadville Ext. 1, Germinston 1422, South AfricaSouth Africa21/08/2018Non Beta lactamNon Beta lactam: • Tablets (Coated and uncoated) • Primary and secondary packaging of imported bulk tablets • Nasal spray/drops/metered dose sprayNon Beta lactam: • Tablets (Coated and uncoated) • Primary and secondary packaging of imported bulk tablets • Nasal spray/drops/metered dose sprayNone10/12/2018 CAPA SubmittedCompliantKaleebu Frank
235IRF/F/009/01/2019 072/GMP/2019 GMP Cert No.Nobel Ilac Sanayii. ve Ticaret. A.S.Sancklar 8110 Duzce , TurkeyTurkey26/10/201820/12/2021Non-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)None22/01/2019 Report DateCompliantAmoreen Naluyima
236IRF/F/216/04/2018- R10 116/GMP/2018North China Pharmaceutical Co., LtdNo.388 Heping Road, Shijiazhuang, Hebei Province, P.R. China. (North Best Branch)China09/03/201809/03/2021Beta-lactam (Penicillin)Beta-lactam (Penicillin) • Tablets (coated and uncoated). • Hard Gelatin Capsules. • Sterile Small Volume Parenteral powdersBeta-lactam (Penicillin) • Tablets (coated and uncoated). • Hard Gelatin Capsules. • Sterile Small Volume Parenteral powdersNone13/07/2018 CAPA SUBMISSIONCompliantEtuko Daniel
237069/GMP/2018 DRNorvatis Pharma Stein AGSchaffhauserstrasse CH-4332, Stein SwitzerlandSwitzerland14/05/201814/05/2021Non Beta LactamTablets (Coated and Uncoated) Small Volume ParenteralsTablets (Coated and Uncoated) Small Volume ParenteralsNone14th May 2018 Report DateCompliantDenis Mwesigwa
238169/GMP/2018 DR2Novo Nordisk A/S, Novo AlleDK 2880, Bagsvaerd DenmarkDenmark25/10/201825/10/2021Non-Beta LactamNon-Beta Lactam Biologicals Insulin (Small Volume Liquids)Non-Beta Lactam Biologicals Insulin (Small Volume Liquids)NoneCompliantKaleebu Frank
239169/GMP/2018 DRNovo Nordisk Production S.A.S5, avenue d’Orleans 28000 Chartres, FranceFrance30/10/201830/10/2021Non-Beta LactamNon-Beta Lactam Insulin (Vials) Insulin (Pre-filled syringes)Non-Beta Lactam Insulin (Vials) Insulin (Pre-filled syringes)NoneCompliantKaleebu Frank
240IRF/F/319/06/2018 R10 096/GMP/2018Octapharma Dessau GmbHOtto-Reuter-str.3 06847 Dessau, Rosslau GermanyGermany18/04/201818/04/2021Blood ProductsBlood Products Packaging of intermediate productsBlood Products Packaging of intermediate productsNone18th June 2018 Report DateCompliantOnen Solomon L.
241IRF/F/318/06/2018 R10 095/GMP/2018Octapharma Produktionsgesellschaft Deutschland Mbh,Wolfgang- Marguerre- Allee 1, 31832 Springe,GermanyGermany17/04/201817/04/2021Blood ProductsBlood Products SVP solutions- Intermediate Albumin solution in vialsBlood Products SVP solutions- Intermediate Albumin solution in vialsNone18th June 2018 Report DateCompliantOnen Solomon L.
242IRF/F/169/01/2018- R7 045/GMP/2018Otsuka Pharmaceutical India Private LimitedSurvey No. 199 to 201 & 208 to 210, MF01 and MF02 village- Vasna chacharwadi, Tal. Sanand District. Ahmedabad-382 213India14/11/201714/11/2020Non- Beta lactam• Large Volume Parenterals (Plastic bottles and Glass bottles) • Small Volume Parenterals (Non PVC bags-single and multi-chamber)• Large Volume Parenterals (Plastic bottles and Glass bottles) • Small Volume Parenterals (Non PVC bags-single and multi-chamber)None27/02/2018 CAPA SubmittedCompliantVictoria Kwesiga
243067/GMP/2019 DRPfizer Ireland Pharmaceuticals Grange Castle.Grange Castle busness park, Clondalkin Dublin 22 - IrelandIreland01/04/201901/04/2022VaccinesVaccines: Prefilled syringesVaccines: Prefilled syringesNoneCompliantOnen Solomon L.
244068/GMP/2019 DRPfizer Pharmaceuticals LLCVega Baja Puerto Rico – United States of AmericaUnited States Of America01/04/201901/04/2022Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneCompliantOnen Solomon L.
245IRF/F/138/11/2017- R6 028/GMP/2018Phaarmasia LtdPlot No.145 Phase –V , IDA Jeedimetia Hyderabad 500 055 Telangana, India.India10/10/201710/10/2020Non Beta Lactam• Tablets (contraceptive hormones) • Ferrous tablets• Tablets (contraceptive hormones) • Ferrous tabletsNone30/01/2018 CAPA SUBMITTEDCompliantOnen Solomon L.
246IRF/F/086/06/2019 139/GMP/2019 Cert No.Pharma International CompanyAl- Qastal area, Airport Road, P.O.Box 334 Al Jubaiha, 11941, Amman- JordanJordan23/04/201923/04/2022Non-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 InjectionNone24th June 2019 Report DateCompliantKaleebu Frank
247IRF/F/126/11/2017-R5 044/GMP/2018Pharma Swede EgyptIndustrial Zone B, 10th of Ramadan City EgyptEgypt10/10/201710/10/2020Vet NBL• Boluses (Tablets) • Oral liquids- Solutions, Suspensions and Emulsions • Oral Powders and Premixes • Small Volume Parenterals • Large Volume Parenterals• Boluses (Tablets) • Oral liquids- Solutions, Suspensions and Emulsions • Oral Powders and Premixes • Small Volume Parenterals • Large Volume ParenteralsNone01/02/2018 CAPA SUBMITTEDCompliantNasser Lubowa
248089/GMP/2018- DRPharmathen S.A6, Dervenakion Str. 15351 Pallini Athens, GreeceGreece06/06/201806/06/2021Non Beta LactamTablets. Hard gelatin capsules. Small volume parenteral (powders) External liquid solutionsTablets. Hard gelatin capsules. Small volume parenteral (powders) External liquid solutionsNone06th June 2018 Report DateCompliantDenis Mwesigwa
249074/GMP/2018 DRPharmazeutische Fabrik Montavit Ges.m.b.HSalzbergstrasse 96 A-6067 Absam, AustriaAustria25/05/201825/05/2021Non Beta lactamTopical Powders Sterile catheter gels in collapsible syringes Non sterile lubricating gelsTopical Powders Sterile catheter gels in collapsible syringes Non sterile lubricating gelsNone25/05/2018 Report DateCompliantDenis Mwesigwa
250IRF/F/004/01/2019 005/GMP/2019 GMP Cert No.Pierre Fabre Medicament production - Aquitaine Pharm International Site 1Avenue du Béarn - 64320 IDRON-FranceFrance16/10/2018Non-beta lactamNon-beta lactam: • SVP liquids (packed in vials & Prefilled syringes). • SVP lyophilized powders(vials)Non-beta lactam: • SVP liquids (packed in vials & Prefilled syringes). • SVP lyophilized powders(vials)None08/01/2019 Report DateCompliantEtuko Daniel
251002/GMP/2018- DRPierre Fabre Medicament(Aquitaine Pharm International site 1)Avenue du Bearn, 64320, Idron, FranceFrance29/09/201729/09/2020Non Beta LactamSVP conventional freeze dried products (lyophilisates)SVP conventional freeze dried products (lyophilisates)None08/01/2017 Second EvaluationCompliantMwesigwa Denis
252IRF/F/429/11/2018 124/GMP/2019 Cert No.PIL Pharmaceuticals LimitedPlot No. 71 & 72, Sector-6A, Sidcul, Haridwar -249403 Uttarakhand, India.India15/09/201815/09/2021Oral solid dosage PenicillinOral solid dosage Penicillin: • Tablets (coated and uncoated) • Hard gelatin capsules • Powder for oral suspension (Dry syrup)Oral solid dosage Penicillin: • Tablets (coated and uncoated) • Hard gelatin capsules • Powder for oral suspension (Dry syrup)None26th November 2018 Report dateCompliantSsali Peter
253141/GMP/2018 DRPinewood Laboratories LtdBally Macarbry, Clonmel Co. Tipperary, IrelandIreland07/09/201807/09/2021Non Beta LactamOral liquids (syrups, suspensions, solutions) External liquids (shampoo, lotions) Semisolids (Creams, Ointments, Gels) & EnemasOral liquids (syrups, suspensions, solutions) External liquids (shampoo, lotions) Semisolids (Creams, Ointments, Gels) & EnemasNoneCompliantDenis Mwesigwa
254IRF/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, IndiaIndia19/02/201919/02/2022Non-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)None27th May 2019 Report DateCompliantOkello Andrew
255IRF/F/370/09/2018 R12 132/GMP/2018Piramal Enterprises LtdSy. Nos 7-70, 70/1 and 70/2, Digwal Village, Kohir Mandal, Medak District, Telangana, IndiaIndia31/07/2018Non beta-lactam.Non beta-lactam. • Manufacture and Packaging of liquid anaestheticsNon beta-lactam. • Manufacture and Packaging of liquid anaestheticsNone03rd September 2018 Report DateCompliantAtumanya Amos
256IRF/F/321/06/2018 R10 185/GMP/2018 GMP Cert NoProfarma . SH. AMyslym Keta, Tirana, AlbaniaAlbania10/04/201810/04/2021Non Beta-lactamNon Beta-lactam • Tablets • Hard gelatin capsules • Dry powder for oral suspension and sachets. • Oral/Nasal/Ear liquids. • Galenic suppositories, cream and ointments. • SVP and LVP solutionsNon Beta-lactam • Tablets • Hard gelatin capsules • Dry powder for oral suspension and sachets. • Oral/Nasal/Ear liquids. • Galenic suppositories, cream and ointments. • SVP and LVP solutionsNone12/09/2018 CAPA SUBMITTEDCompliantOnen Solomon L.
257IRF/F/428/11/2018 123/GMP/2019 Cert No.Psychotropics India LtdPlot No. 46 & 49, Sector 6A, IIE, SIIDCUL, Haridwar -249403, Uttrakhand, IndiaIndia18/09/201818/09/2021Non beta lactamNon beta lactam: • Tablets (coated and uncoated) • Oral liquids • Creams, ointments and lotionsNon beta lactam: • Tablets (coated and uncoated) • Oral liquids • Creams, ointments and lotionsNone26th November 2018 Reprt dateCompliantSsali Peter
258IRF/F/168/01/2018 R8 040/GMP/2018PT Medion Farma JayaBatujajar 29, Cimareme, Ngamprah, Bandung Barat, West Java, Indonesia.Indonesia27/10/201727/10/2020Non Beta Lactam lines Beta Lactam lines (penicillin) BiologicalsNBL; Tablets Hard gelatin capsules Powders in sachets Oral liquids Small Volume Parenteral. BL (penicillin); Powders in sachets Biologicals; Live and inactivated virus Vaccines Inactivated bacterial VaccinesNBL; Tablets Hard gelatin capsules Powders in sachets Oral liquids Small Volume Parenteral. BL (penicillin); Powders in sachets Biologicals; Live and inactivated virus Vaccines Inactivated bacterial VaccinesNone16/03/2018 CAPA SUBMITTEDCompliantAkali Alfred
259IRF/F/151/12/2017- R6 033/GMP/2018PT SANBE FARMA UNIT 2Jl. Leuwigajah Indonesia, NO.162, Cimindi, IndonesiaIndonesia17/10/201717/10/2020BL Penicillins CephalosporinsPenicillins • Tablets • Hard gelatin capsules • Dry powder for oral suspension • Powders for injection (SVP) Cephalosporins • Tablets • Hard gelatin capsules • Dry powder for oral suspension • Powders for injection (SVP)Penicillins • Tablets • Hard gelatin capsules • Dry powder for oral suspension • Powders for injection (SVP) Cephalosporins • Tablets • Hard gelatin capsules • Dry powder for oral suspension • Powders for injection (SVP)None31/03/2018 CAPA SUBMITTEDCompliantAkali Alfred
260IRF/F/160/01/2018- R7 110/GMP/2018PT Sydna FarmaJl RC Veteran No.89-Bintaro,Jarkata, 12330, IndonesiaIndonesia31/10/201731/10/2020Non-beta lactam• Hormonal and non-Hormonal Tablets (Coated and Uncoated) • Small Volume Parenteral powders and solutions (Hormonal)• Hormonal and non-Hormonal Tablets (Coated and Uncoated) • Small Volume Parenteral powders and solutions (Hormonal)None07/03/2018 CAPA SUBMITTEDCompliantAkali Alfred
261IRF/F/159/01/2018- R6 111/GMP/2018PT. Novell Pharmaceutical LaboratoriesJI. Wanaherang no 35,TIajung Udik, Gunung Putri, Bogor 16962, Indonesia.Indonesia20/10/201720/10/2020Non-beta lactam• Tablets • Hard gelatin capsules • Soft Gelatin capsules • Oral powders in sachets • Small Volume Parenteral (Powders and solutions) • Small Volume Parenteral(Lyophilized) • Oral liquids• Tablets • Hard gelatin capsules • Soft Gelatin capsules • Oral powders in sachets • Small Volume Parenteral (Powders and solutions) • Small Volume Parenteral(Lyophilized) • Oral liquidsNone03rd January 2018 REPORT DATECompliantAkali Alfred
262062/GMP/2018 DRQuesta Care LimitedPlot No. 209/7185 Homabay Road, Industrial Area. P.O.BOX 172-00623. NairobiKenya08/05/201808/05/2021Non Beta LactamTabletsTabletsNone08th May 2018 Report DateCompliantDenis Mwesigwa
263IRF/F/058/03/2019 148/GMP/2019 Cert No.Ra Chem Pharma LimitedPlot No. A-19/C, Road No.18 IDA Nacharam, Hyderabad – 76 Telangana state, India.India23/11/201823/11/2021Non-Beta LactamNon-Beta Lactam • Tablets (Coated and Uncoated) • Hard Gelatin Capsules • PelletsNon-Beta Lactam • Tablets (Coated and Uncoated) • Hard Gelatin Capsules • PelletsNone21st March 2019 Report dateCompliantNasser Lubowa
264IRF/F/105/08/2017 - R4 021/GMP/2018 Cert No.Raptakos Brett & Co. Ltd1st Pokhran Road, Thane 400606 IndiaIndia17/10/201717/10/2020NBLNon Beta Lactam line; ? Ointments (semi-solids) ? Oral LiquidsNon Beta Lactam line; ? Ointments (semi-solids) ? Oral LiquidsNoneCompliantVictoria Kwesiga
265IRF/F/069/05/2019 181/GMP/2019 Cert No.Raptakos Brett and Company Limited100/2 M.I.D.C. Dhatav, Roha 402 116 Maharashtra IndiaIndia22/01/201922/01/2022Non-beta lactamNon-beta lactam: • Hard Gelatin CapsulesNon-beta lactam: • Hard Gelatin CapsulesNone10th May 2019 GMP Report DateCompliantWilberforce Kwiringira
266IRF/F/142/11/2017- R6 021/GMP/2018RAPTAKOS, BRETT & CO. LTD.1st Pokhran Road, Thane 400606, MIDC, Maharashtra, IndiaIndia17/10/201717/10/2020Non Beta lactamOral liquids Topical Ointments and creamsOral liquids Topical Ointments and creamsNone11/01/2018 CAPA SubmittedCompliantMuhammad I. Lukwago
267IRF/F/343/07/2018 R11 188/GMP/2018 GP Cert No.Ratnamani Healthcare Pvt. LtdSurvey No. 750/1, Ahmedabad-Mehsana Highway, Village Indrad, Nr. Chhatral, G.I.D.C, Kadi-382721 District Mehsana Gujarat State, India.India15/06/201815/06/2021Non Beta lactamNon Beta lactam • Tablet (Coated and Uncoated) • Hard gelatin shell Capsule • Dry powder for Oral suspension • ORS • SVP Dry powder for injection (Vials) • SVP Liquid (in Ampoules) • SVP Liquid (in Vials)Non Beta lactam • Tablet (Coated and Uncoated) • Hard gelatin shell Capsule • Dry powder for Oral suspension • ORS • SVP Dry powder for injection (Vials) • SVP Liquid (in Ampoules) • SVP Liquid (in Vials)None26/10/2018 CAPA SUBMITTEDCompliantDennis Mwesigwa
268IRF/F/018/02/2019 073/GMP/2019 GMP Cert No.Recipharm Pharmaservices Pvt. Limited34th KM, Tumkur Road, T. Begur, Nelamangana, Bengaluru - 562123, India.India27/11/2018Non-Beta LactamNon-Beta Lactam: • Tablets (coated and uncoated)Non-Beta Lactam: • Tablets (coated and uncoated)None05th February 2019 Report dateCompliantNasser Lubowa
269IRF/F/035/02/2019 073/GMP/2019 GMP Cert No.Recipharm Pharmaservices Pvt. Limited34th KM, Tumkur Road, T. Begur, Nelamangala, Bengaluru - 562123, India.India27/11/2018Non-beta LactamNon-beta Lactam: • Tablets (coated and uncoated)Non-beta Lactam: • Tablets (coated and uncoated)None14th February 2019 Report DateCompliantNasser Lubowa
270IRF/F/371/09/2018 R12 043/GMP/2019 GMP Cert No.Reckitt Benckiser HealthcareDansom Lane, Hull, HU8 7DS, United KingdomUnited Kingdom05/06/2018Non Beta lactamNon Beta lactam • Tablets • Oral liquidsNon Beta lactam • Tablets • Oral liquidsNone10/12/2018 CAPA SUBMITTEDCompliantWilberforce Kwiringira
271IRF/F/375/09/2018 R12 043/GMP/2019 GMP Cert No.Reckitt Benckiser HealthcareThane Road, Nottingham NG 902DB, United KingdomUnited Kingdom08/06/2018Non Beta lactamNon Beta lactam • Tablets (Coated & Uncoated) • Packaging of soft gelatin capsules.Non Beta lactam • Tablets (Coated & Uncoated) • Packaging of soft gelatin capsules.None10/12/2018 CAPA SUBMITTEDCompliantWilberforce Kwiringira
272IRF/F/308/05/2018 R10Regal Pharmaceuticals Limited.Plot 7879/18 Off Baba Dogo Road, Ruaraka, P.O. Box 44421-00100, Nairobi Kenya.Kenya13/04/201813/04/2021Non beta lactam Beta lactam (Penicillin)Non beta lactam Tablets (coated & uncoated) Hard gelatin capsules Oral powder in bottles Oral liquids Creams and Ointments Beta lactam (Penicillin) Tablets (uncoated) Hard gelatin capsules Oral powdersNon beta lactam Tablets (coated & uncoated) Hard gelatin capsules Oral powder in bottles Oral liquids Creams and Ointments Beta lactam (Penicillin) Tablets (uncoated) Hard gelatin capsules Oral powdersNone23/10/2018 CAPA SUBMITTEDCompliantAtumanya Amos
273012/GMP/2018- DRRemedica LtdAharnon Street, Limassol Industrial Estate, 3056 Limassol.Cyprus01/12/201701/12/2020Non Beta Lactam Beta Lactam Hormones, CytotoxicNon Beta Lactam Tablets Capsules Powders for oral suspension Creams, Ointments & Lotions Beta Lactam Tablets Capsules Powders for oral suspension Hormones, Cytotoxic TabletsNon Beta Lactam Tablets Capsules Powders for oral suspension Creams, Ointments & Lotions Beta Lactam Tablets Capsules Powders for oral suspension Hormones, Cytotoxic TabletsNone28/01/2018 SECOND EVALUATIONCompliantDenis Mwesigwa
274IRF/F/395/09/2018 R12 065/GMP/2019 GMP Cert No.Remidex Pharma Pvt LtdB-249/250,Peenya Industries Estate 2nd Stage Peenya Bangalore-560058 India.India17/08/2018Non beta-lactamNon beta-lactam • Tablets (coated)Non beta-lactam • Tablets (coated)None03/12/2018 CAPA SubmittedCompliantVictoria Kwesiga
275IRF/F/001/01/2019 072/GMP/2019 GMP Cert No.Rene Industries LimitedPlot 680, Kamuli Road, Kireka P.O. Box 6034, Kampala, UgandaUganda20/12/2018Beta 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 capsulesNone10/01/2019 Report DateCompliantOnen Solomon L.
276003/GMP/2019 DRRoche Diagnostics Gmbh. MannheimSandhoffer Street 116, GermanyGermany03/01/201903/01/2022Non-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 LyophilisatesNoneCompliantKaleebu Frank
277IRF/F/340/07/2018 R11 039/GMP/2019 GMP Cer No.Ronak Biopharmaceutical CoKargar BLVD, Azadegan 2 Ave, Azadegan BLVD, Kaveh Industrial City, Saveh– Iran.Iran20/05/2018NBL (General pdcts & Biological pdcts; Insulin, Gonadotropins, Enoxaparin)Non Beta lactam SVP Injections liquids SVP (lyophilised powders) for Injections SVP Injections liquids (Pre filled syringes) Biological products (SVP liquids, SVP Lyophilized powders, Prefilled syringes)Non Beta lactam SVP Injections liquids SVP (lyophilised powders) for Injections SVP Injections liquids (Pre filled syringes) Biological products (SVP liquids, SVP Lyophilized powders, Prefilled syringes)NoneCompliantEtuko Daniel
278IRF/F/378/09/2018 R12 044/GMP/2019 GMP Cert No.Saga LaboratoriesSurvey No. 198/2 and 198/3, Chacharwadi Vasna Tal District - Sanad Ahmedabad 380 015 Gujarat IndiaIndia03/08/2018Beta lactam (Cephalosporin) Non-beta LactamBeta lactam (Cephalosporin) • Tablets • Hard Gelatine capsules • Powders for oral suspension Non-beta Lactam • Tablets • Hard Gelatine Capsules • Powders for oral suspensionBeta lactam (Cephalosporin) • Tablets • Hard Gelatine capsules • Powders for oral suspension Non-beta Lactam • Tablets • Hard Gelatine Capsules • Powders for oral suspensionNone10/10/2018 CAPA SUBMITTEDCompliantEtuko Daniel
279IRF/F/166/01/2018- R7 046/GMP/2018Sance Laboratories Pvt LtdVI/51B, P.B. No.2, Kozhuvanal, Pala, Kottayam District-686573, Kerala, India.India07/11/201707/11/2020Beta lactam- Cephalosporin;Tablets Dry powders for injection Hard gelatin capsules Dry powders for oral suspensionTablets Dry powders for injection Hard gelatin capsules Dry powders for oral suspensionNone15/03/2018 CAPA SubmittedCompliantVictoria Kwesiga
280166/GMP/2018 DRSandoz S.R.L. Targu-Mures SiteSandoz S.R.L. Str. Livezeni nr. 7a 540472 Targu-Mures RomaniaRomania30/10/201830/10/2021Non-Beta LactamNon-Beta Lactam Hard Gelatin Capsules Tablets (Coated and Uncoated) Powders (Granules for Oral Suspension)Non-Beta Lactam Hard Gelatin Capsules Tablets (Coated and Uncoated) Powders (Granules for Oral Suspension)NoneCompliantDenis Mwesigwa
281IRF/F/038/02/2019 166/GMP/2019 Cert No.Sanjar Pharmaceuticals LimitedSurvey No. 622/2/1/4, Dedhrota, Ta- Himatnagar, dist Sabarkantha, Gujarat, IndiaIndia12/09/201912/09/2022Non-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 injectionNone22nd February 2019 Report DateCompliantAnnet Ssekindu
282139/GMP/2018 DRSanofi Aventis, S.ACtra. C-35 (La Batlloria- Hostalric, Km. 63,09) Riells i Viabrea, Gerona, 17404, SpainSpain07/09/201807/09/2021Non Beta LactamTabletTabletNoneCompliantDenis Mwesigwa
283061/GMP/2019 DRSanofi Winthdrop Industrie1 rue de la vierge, FranceFrance14/03/201914/03/2022Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneCompliant
284IRF/F/335/06/2018 R10 050/GMP/2019 GMP Cert No.Sava Healthcare LimitedPlot No. 507B-512 GIDC Estate, Wadhwan City-363035, Dist. Surendranagar Gujarat, IndiaIndia04/05/2018Non-Beta LactamNon-Beta Lactam • Nasal Spray • Soft gelatin capsules (Respicaps) • Tablets (Coated and uncoated) • Creams, ointment and gels. • Dry Powder for suspensions.Non-Beta Lactam • Nasal Spray • Soft gelatin capsules (Respicaps) • Tablets (Coated and uncoated) • Creams, ointment and gels. • Dry Powder for suspensions.None10/10/2018 CAPA SUBMITTEDCompliantAnnet Ssekindu
285IRF/F/074/05/2019 138/GMP/2019 GMP Cert No.Scott-Edil Pharmacia Ltd (Unit I)56, EPIP, Phase-1, Jharmajri, Baddi, Distt. Solan, (H.P), IndiaIndia27/11/201827/11/2021Non-Beta LactamNon-Beta Lactam: • Tablets • Hard gelatin capsules • Oral liquids • External creams, ointments • Sterile eye drops and nasals • SVP-solutions • SVP-powdersNon-Beta Lactam: • Tablets • Hard gelatin capsules • Oral liquids • External creams, ointments • Sterile eye drops and nasals • SVP-solutions • SVP-powdersNone14th May 2019 Report DateCompliantOnen Solomon L.
286IRF/F/344/07/2018 R11 183/GMP/2018 GMP Cert NoScott-Edil Advance research Laboratories and Education Ltd (SEARLE).Hilltop Industrial Area, Bhatoli Kalan, Baddi DistrictSolan – Himachal Pradesh, India.India05/06/201805/06/2021Beta Lactam (Cephalosporin):Beta Lactam (Cephalosporin): • Dry powder for injection • Tablet (Coated and Uncoated • Hard gelatin shell Capsule • Dry powder for oral suspensionBeta Lactam (Cephalosporin): • Dry powder for injection • Tablet (Coated and Uncoated • Hard gelatin shell Capsule • Dry powder for oral suspensionNone16/11/2018 CAPA SUBMITTEDCompliantDenis Mwesigwa
287IRF/F/148/11/2017- R6 023/GMP/2018Searle Pakistan LimitedF-319, S.I.T.E Opposite K.E.S.C Power Station Karachi-75530, PakistanPakistan06/10/201706/10/2020Non-beta-lactam• Oral Liquids • Hard gelatin capsules • Tablets • SVPs • Powders in sachets• Oral Liquids • Hard gelatin capsules • Tablets • SVPs • Powders in sachetsNone23/02/2018 GMP ISSUE DATECompliantZaidi Mwondha
288IRF/F/384/09/2018 R12 073/GMP/2019 GMP Cert No.Shin Poong Pharma. Co., Ltd70, Sandan-ro,19beon-gil, Danwon-gu, Ansan-si, Gyeonggi-do, South Korea.Korea, Republic of (South)14/08/2018Non Beta lactamNon Beta lactam • Tablets (coated and uncoated) • Oral granules (sachets)Non Beta lactam • Tablets (coated and uncoated) • Oral granules (sachets)None13th September 2018 REPORT DATECompliantOnen Solomon L.
289IRF/F/327/06/2018 R10 102/GMP/2018Sinergium Biotech SARuta Panamericana Km 38.7 Garin Buenos Aires, Argentina.Argentina11/05/201811/05/2021Non Beta Lactam biopharmaceutical line;Small Volume Parenteral solutions -Recombinant Monoclonal Antibodies.Small Volume Parenteral solutions -Recombinant Monoclonal Antibodies.None22nd June 2018 Report DateCompliantNasser Lubowa
290IRF/F/376/09/2018 R12 136/GMP/2018Sirmaxo Chemicals Pvt LtdPlot E-35 MIDC Tarapur District :Palghar Thane MaharashtraIndia03/08/2018Non beta-lactam Disinfectants and antisepticsNon beta-lactam Disinfectants and antiseptics • Solutions • Emulsions • GelsNon beta-lactam Disinfectants and antiseptics • Solutions • Emulsions • GelsNone07th September 2018 REPORT DATECompliantOkello Andrew
291199/GMP/2018 DRSofarimex Idustria Quimica e Farmaceutica SAAvenida das Industrias, Alto do Colaride Aguaviva, PortugalPortugal30/11/2018Non-Beta LactamNon-Beta Lactam Hard-Gelatin Capsules Semi-solids TabletsNon-Beta Lactam Hard-Gelatin Capsules Semi-solids TabletsNoneCompliantKaleebu Frank
292IRF/F/380/09/2018 R12 008/GMP/2019 GMP Cert No.Sparsh Bio-Tech Pvt. LtdPlot No. 1, Survey No.242/243/244, Lakhabavad, Jamnagar Gujarat- 361006, IndiaIndia31/07/201831/07/2021Beta lactam (Penicillin)Beta lactam (Penicillin) • Tablets • Hard Gelatin capsules • Powders for oral suspensionBeta lactam (Penicillin) • Tablets • Hard Gelatin capsules • Powders for oral suspensionNone26/10/2018 CAPA SUBMITTEDCompliantEtuko Daniel
293IRF/F/332/06/2018 R10 173/GMP/2018 GMP Cert No.Specpharm Holdings (Pty) Ltd15th Roads, Half way house 1685, Midrand South AfricaSouth Africa26/04/201826/04/2021Non Beta-lactamNon Beta-lactam • Tablets • External Semi Solids (creams and Ointment)Non Beta-lactam • Tablets • External Semi Solids (creams and Ointment)NoneCAPA SubmittedCompliantNambasa Victoria
294IRF/F/409/10/2018 156/GMP/2018 GMP Cert No.Square Pharmaceuticals LimitedDhaka Unit Kaliakoir Gazipur, 1750 BangladeshBangladesh27/09/2018Beta Lactam preparations (Cephalosporins) Non-beta lactam preparationsTablets Capsules Powders for oral suspension SVP powders for injection Eye/Ear drops Nasal drops Nebulizer solutions Insulin (Vials and Cartridges) Preparations in Prefilled Syringes Metered Dose InhalersTablets Capsules Powders for oral suspension SVP powders for injection Eye/Ear drops Nasal drops Nebulizer solutions Insulin (Vials and Cartridges) Preparations in Prefilled Syringes Metered Dose InhalersNone18/10/2018 GMP Report DateCompliant
295IRF/F/024/02/2019 085/GMP/2019 GMP Cert No.Stanford Laboratories Pvt. Limited8 Industrial area, Mehatpur- 174315, Himachal Pradesh- IndiaIndia13/12/2018Non-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 sachetsNone13th February 2019 Report dateCompliantNambasa Victoria
296IRF/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, IndiaIndia07/05/201907/05/2022Non-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 / gelsNone30th July 2019 Report dateCompliantNasser Lubowa
297IRF/F/046/02/2019 155/GMP/2019 GMP Cert No.Sun Pharmaceutical Industries LimitedB-2 Madkai Industrial Estate Madkai Ponda-Goa-403404 IndiaIndia07/12/201807/12/2021Non-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-steroidNone21st February 2019 Report DateCompliantZaid Mwonda
298IRF/F/109/07/2019 109/GMP/2019 GMP Cert No.Sun Pharmaceutical Industries LimitedIndustrial Area 3, A.B. Road, Dewas 455001, Madhya Pradesh, IndiaIndia10/05/2019Penem 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 SuspensionsNone16th July 2019 Report dateCompliantVictoria Kwesiga
299IRF/F/147/11/2017- R6 024/GMP/2018Surge Laboratories (Pvt.) Ltd10th Km, Faisalabad Road, Bikhi, District Sheikhupura, PakistanPakistan13/10/201713/10/2020non-beta-lactam Cephalosporin beta-lactam• Small volume parenteral solutions (in ampoules) non-beta-lactam. • Small volume parenteral (powders for injection) Cephalosporin beta-lactam.• Small volume parenteral solutions (in ampoules) non-beta-lactam. • Small volume parenteral (powders for injection) Cephalosporin beta-lactam.None19/01/2018 CAPA SUBMITTEDCompliantZaidi Mwondha
300IRF/F/219/04/2018 R10 100/GMP/2018Svizera Laboratories Private LimitedD16/6 TCC Industrial Area, Turbhe, Navi Mumbai, India.India27/02/201827/02/2021Non Beta-lactamNon Beta-lactam • Tablets (Coated and Uncoated) • Capsules (Hard Gelatin Shell)Non Beta-lactam • Tablets (Coated and Uncoated) • Capsules (Hard Gelatin Shell)None27th Feb 2018 Report DateCompliantDavid Nahamya
301IRF/F/121/10/2017 - R5 011/GMP/2018 GMP CertSwiss Garnier Life Sciences21-23 Industrial Area Mehatpur Dist Una, Himachal Pradesh 174315 IndiaIndia13/10/201713/10/2020NBLNon beta-lactam. • Tablets • Hard gelatin capsules • Oral liquid • Oral powder in sachets • Ointments, gels and creamsNon beta-lactam. • Tablets • Hard gelatin capsules • Oral liquid • Oral powder in sachets • Ointments, gels and creamsNone28/11/2017 CAPA SubmittedCompliantOkello Andrew
302IRF/F/405/10/2018 R12 181/GMP/2018 GMP Cert NoSwiss Parenterals ltd-Unit I808,809 & 810 Kerala Industrial Estate, GIDC, 382 220 Gujarat- IndiaIndia28/08/201828/08/2021Penicillin parenteral formulations Non-beta lactam parenteral formulationsPenicillin SVP (Dry powders for inj; excluding diluents and adjuncts). Non-beta lactam SVP (liquids for inj in ampoules, vials). SVP (dry powder for inj in vials; excluding diluents and adjuncts). Sterile Ophthalmic and ear prepns.Penicillin SVP (Dry powders for inj; excluding diluents and adjuncts). Non-beta lactam SVP (liquids for inj in ampoules, vials). SVP (dry powder for inj in vials; excluding diluents and adjuncts). Sterile Ophthalmic and ear prepns.NoneCAPA SubmittedCompliantDennis Mwesigwa
303IRF/F/406/10/2018 R12 182/GMP/2018 GMP Cert NoSwiss Parenterals ltd-Unit II402, 412-414 Kerala Industrial Estate, GIDC, Gujarat- IndiaIndia21/08/201821/08/2021Beta-Lactam CephalosporinBeta-Lactam Cephalosporin • SVP (Dry powder for injection)Beta-Lactam Cephalosporin • SVP (Dry powder for injection)NoneCAPA SubmittedCompliantDenis Mwesigwa
304047/GMP/2019 DRTECHPharm GmbHDraisstr. 14 76646 BruschsalGermany18/02/201918/02/2022Quality Control Testing Stability studiesQuality Control Testing Stability studiesQuality Control Testing Stability studiesNoneCompliant
305IRF/F/357/08/2018 R12 100/GMP/2019 GMP Cert No.Tenth Of Ramadan for Pharmaceutical Industries and Diagnostic Reagents (Rameda).Second Industrial Zone Plot No. 5 Six of October City, EgyptEgypt10/07/201810/07/2021Non ?-lactam Penicillin CephalosporinsNon ?-lactam Ophthalmic line (Eye drops, SVP injection solution in Vials and water for injection – FFS) Oral liquid Dry powder filled in sachets. Oral Dry powder Tab Caps Penicillin Tab Caps Cephalosporins SVP powder sterileNon ?-lactam Ophthalmic line (Eye drops, SVP injection solution in Vials and water for injection – FFS) Oral liquid Dry powder filled in sachets. Oral Dry powder Tab Caps Penicillin Tab Caps Cephalosporins SVP powder sterileNone27th August 2018 Report DateCompliantKenneth Kiiza
306IRF/F/315/06/2018 R10 148/GMP/2018The Arab Pesticide & Veterinary Drugs Manufacturing Company.Al Hassan Industrial Estate P.O. Box 45- Irbid- Jordan.Jordan09/04/201809/04/2021Non Beta-lactamNon Beta-lactam • Water Soluble Powders for Oral Solutions • Oral liquids • Small volume parenteral solutions • Ectoparasiticides. • Aerosol.Non Beta-lactam • Water Soluble Powders for Oral Solutions • Oral liquids • Small volume parenteral solutions • Ectoparasiticides. • Aerosol.NoneCAPA SUBMISSIONCompliantZaid Mwonda
307IRF/F/132/11/2017- R5, Gmp Cert 001/GMP/2018The Madras Pharmaceuticals137-B, old Mahabalipuram Road, Karapakkam, Chennai-600 096, Tamil Nadu state- INDIAIndia13/10/201713/10/2020Non beta lactam• Tablets (coated and uncoated) • Hard Gelatin Capsules • Dry Syrups • Oral Liquids • Ointments, gels and Creams• Tablets (coated and uncoated) • Hard Gelatin Capsules • Dry Syrups • Oral Liquids • Ointments, gels and CreamsNone08/01/2018 Issued GMP CertCompliantNsereko Henry
308IRF/F/345/07/2018 R11Theon Pharmaceuticals LtdVillage Saini Majra, Tehsil Nalagarh District, Solan – 174101, Himachal Pradesh state – IndiaIndia01/06/201801/06/2021Non Beta Lactam Beta Lactam (Penicillin) Beta Lactam (Cephalosporin)NBL Tab HG Caps Dry powder for Oral Suspension Creams and Ointments BL(Penicillin) Tab HG Caps BL(Cephalosporin): Tabs HG Caps Dry powder for Oral Suspension Dry powder for injection (SVP)NBL Tab HG Caps Dry powder for Oral Suspension Creams and Ointments BL(Penicillin) Tab HG Caps BL(Cephalosporin): Tabs HG Caps Dry powder for Oral Suspension Dry powder for injection (SVP)None05/09/2018 CAPA SUBMITTEDCompliantDennis Mwesigwa
309IRF/F/200/02/2018- R9 018/GMP/2018TIL Healthcare Pvt LimitedPlot 100, west R-5, South, Sricity Sez, Cherive9 (Vi), District: Chitoor 517588 Andhra Pradesh- IndiaIndia17/11/2017Non-beta lactam:Non-beta lactam: Tablets Hard gelatin capsules Oral liquids Dry powders for oral suspensions in bottles Dry powders for oral suspension in SacketsNon-beta lactam: Tablets Hard gelatin capsules Oral liquids Dry powders for oral suspensions in bottles Dry powders for oral suspension in SacketsNone08/02/2018 GMP CERT ISSUE dateCompliantEtuko Daniel
310IRF/F/139/11/2017- R6Torrent Pharmaceuticals LtdIndrad-382721, Tal: Kadi, City: Indrad, Dist Mehsana Gujarat State, IndiaIndia04/10/2017Non Beta Lactam• Tablets • Hard Gelatin capsules• Tablets • Hard Gelatin capsulesNoneCompliantOnen Solomon L.
311IRF/F/307/04/2018 R10 177/GMP/2018 Cert No.Triveni Formulations LtdPlot 52-ALEAP Industrial Estate, Surampali, Vijayawada 520010 – IndiaIndia09/03/201809/03/2021Non Beta Lactam linesNon Beta Lactam lines; • Tablets (Coated and Uncoated) • Capsules (Hard Gelatin Shell) • Creams and OintmentsNon Beta Lactam lines; • Tablets (Coated and Uncoated) • Capsules (Hard Gelatin Shell) • Creams and OintmentsNon Beta Lactam line; • Oral Liquids10/10/2018 CAPA SUBMITTEDCompliantNahamya David
312IRF/F/419/10/2018 207/GMP/2018 GMP Cert No.Troikaa Pharmaceuticals Limited - Thol PlantKadi Road Thol 382728 Dist Mehsana Gujarat - India.India18/09/201818/09/2021Non beta lactamNon beta lactam: • Small Volume liquids for injection (Ampoules & vials) • Powders for injection (vials) • Liquids for inhalation • Tablets • Liquids for external useNon beta lactam: • Small Volume liquids for injection (Ampoules & vials) • Powders for injection (vials) • Liquids for inhalation • Tablets • Liquids for external useNone26/11/2018 CAPA SUBMITTEDCompliantAtumanya Amos
313IRF/F/141/11/2017- R6 027/GMP/2018Troikaa Pharmaceuticals LtdC-1 Sara Industrial Estate, Selaqui, Dehradun- 248197, Uttarakhand, IndiaIndia13/10/201713/10/2020Non Beta lactam• Tablets (Coated and uncoated) • Hard gelatin capsules (solid filled and liquid filled) • Small Volume Parenteral liquids (vials and ampoules)• Tablets (Coated and uncoated) • Hard gelatin capsules (solid filled and liquid filled) • Small Volume Parenteral liquids (vials and ampoules)None08/01/2018 CAPA SubmittedCompliantMuhammad I. Lukwago
314IRF/F/353/08/2018 R12Troikaa Pharmaceuticals LtdSanand, District Ahmedabad 382170 India.India26/06/201826/06/2021Non-beta lactamNon-beta lactam • Topical ointments, creams and gels • Topical solutionsNon-beta lactam • Topical ointments, creams and gels • Topical solutionsNoneCAPA SubmittedCompliantLukwago Mohammad
315IRF/F/381/09/2018 R12Twenty First Century Pharmaceutical Pvt LtdKhasra No. 282, Nalheri Dehviran, Nalhera Anantpor, Puhana Iqbalpur Road, Roorkee 247668 Dist Haridwar Uttarakhand, IndiaIndia27/07/201827/07/2021Beta lactam (Cephalosporin) Beta lactam (Penicillins)Beta lactam (Cephalosporin) • Tablets • Dry Powders for oral suspension Beta lactam (Penicillins) • Tablets • Dry Powders for oral suspensionBeta lactam (Cephalosporin) • Tablets • Dry Powders for oral suspension Beta lactam (Penicillins) • Tablets • Dry Powders for oral suspensionNone23/10/2018 CAPA SUBMITTEDCompliantEtuko Daniel
316IRF/F/303/04/2018 R10 108/GMP/2018Umedica Laboratories Pvt. LtdPlot 221-GIDC, 2nd Phase, Vapi 396195 Gujarat – IndiaIndia06/03/201806/03/2021Non Beta-lactamNon Beta-lactam • Tablets (Coated and Uncoated) • Capsules (Hard Gelatin Shell) • Dry powder for reconstitution • Vaginal tablets • SVP- Liquid Injection (Vials and Ampoules) • SVP- Dry powder for Injection (Vials)Non Beta-lactam • Tablets (Coated and Uncoated) • Capsules (Hard Gelatin Shell) • Dry powder for reconstitution • Vaginal tablets • SVP- Liquid Injection (Vials and Ampoules) • SVP- Dry powder for Injection (Vials)None04/07/2018 CAPA SUBMISSIONCompliantNahamya David
317IRF/F/157/01/2018- R6 086/GMP/2018Uni medicolabs21-22, Pharma City, Selaqui, Dehradun-248011, Uttarakhand, India.India25/10/201725/10/2020Non-beta lactam Beta lactam(penicillin)Non-beta lactam; • Tablets • Hard Gelatin capsules. Beta lactam(penicillin) • Tablets. • Hard gelatin capsules. • Oral dry powder for suspension • Small volume parenteral (powders)Non-beta lactam; • Tablets • Hard Gelatin capsules. Beta lactam(penicillin) • Tablets. • Hard gelatin capsules. • Oral dry powder for suspension • Small volume parenteral (powders)None09/03/2018 CAPA SubmittedCompliantOnen Solomon L.
318IRF/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.India14/12/2018Non-?eta LactamNon-?eta Lactam: • Tablets (coated and uncoated) • Hard gelatin capsulesNon-?eta Lactam: • Tablets (coated and uncoated) • Hard gelatin capsulesNone20th March 2019 Report dateCompliantZaid Mwonda
319IRF/F/175/01/2018- R8 014/GMP/2018Unichem Laboratories LimitedC–31,32 & D-10, Industrial Area, Meerut Road, Ghaziabad, U.P. India.India21/11/2017Non-beta lactamNon-beta lactam • Tablets • Hard Gelatin Capsules • Oral liquids • SVP in AmpoulesNon-beta lactam • Tablets • Hard Gelatin Capsules • Oral liquids • SVP in AmpoulesNONE22/01/2018 GMP Issue dateCompliantEtuko Daniel
320IRF/F/029/02/2019 091/GMP/2019 Cert No.Unique Pharmaceutical LaboratoriesPlot No. 215-219 and 304-308, GIDC Industrial Estate Panoli-394116. Gujarat, Indiauganda11/12/201811/12/2021Non-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 ointmentsNone14th February 2019 Report DateCompliantOnen Solomon L.
321IRF/F/091/07/2019 101/GMP/2019 GM Cert No.Unique Pharmaceutical LaboratoriesPlot No. 4, GIDC Industrial Area Panoli-394116. Bharuch Gujarat, IndiaIndia05/03/2019Non-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 InjectionNone05th July 2019 Report DateCompliantKenneth Kiiza
322IRF/F/082/05/2019 171/GMP/2019 Cert No.United Pharmaceuticals Manufacturing Limited CompanyAl-Rageem, Sahab, P.O.Box 69, Amman 11591- JordanJordan12/04/201912/04/2022Non-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) SuppositoriesNone29th May 2019 Report DateCompliantKaleebu Frank
323067/GMP/2018 DRUniversal Corporation LimitedPlot No 13777, P. O. BOX 1748-00902 Kikuyu Club Road.Kenya17/05/201817/05/2021Non Beta LactamTablets (Coated and Uncoated) Capsules Oral Liquids Powders for Oral Suspension Creams, Ointment and Gels Oral Rehydration SaltsTablets (Coated and Uncoated) Capsules Oral Liquids Powders for Oral Suspension Creams, Ointment and Gels Oral Rehydration SaltsNone17th May 2018 Report DateCompliantDenis Mwesigwa
324IRF/F/040/02/2019 184/GMP/2019 Cert No.Venus Remedies LimitedHill Top Industrial Estate Tharmajiri EP.IP.Phase 1; Baddi; Himachal Pradesh, India.India23/11/201823/11/2021Beta Lactam Cabapenems Beta Lactam Cephalosporin Non-Beta Lactam OncologyBL Cabapenems SVP Powders for injections. BL Cephalosporin SVP Powders for injections. NBL SVP Liquids (Prefilled syringes, Vials and Ampules) SVP Liquids and lyophilized Oncology SVP Liquids and lyophilized injectionsBL Cabapenems SVP Powders for injections. BL Cephalosporin SVP Powders for injections. NBL SVP Liquids (Prefilled syringes, Vials and Ampules) SVP Liquids and lyophilized Oncology SVP Liquids and lyophilized injectionsNone22nd February 2019 Report DateCompliantAnnet Ssekindu
325021/GMP/2019 DRVet Pharma Friesoythe Gmbh, GermanyVet PharmaFriesoythe Gmbh, Seelsberger Street @-4, 26169, GermanyGermany24/01/201924/01/2022Aseptically 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 LiquidsNoneCompliantKaleebu Frank
326IRF/F/081/05/2019 176/GMP/2019 Cert No.Veterinary and Agricultural Products Manufacturing Company Limited (VAPCO)Dhulail Province, King Hussein St. 120/Zarka- JordanJordan28/04/201928/04/2022Non-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 useNone29th May 2019 Report DateCompliantKaleebu Frank
327IRF/F/057/03/2019 134/GMP/2019 Cert No.Virchow Biotech Pvt. LimitedSurvey No 172 part, Gagillapur, Dundigal, Medchal District, Telangana- 500 043, IndiaIndia21/11/201821/11/2021Biologicals Non-Beta Lactam ActivitiesBiologicals Injectable Proteins Blood and sera Oral liquids-Probiotics Non-Beta Lactam SVP Solutions in Catridges, Syringes and Vials SVP Powders Creams and ointments Hard Gelatin Capsules TabletsBiologicals Injectable Proteins Blood and sera Oral liquids-Probiotics Non-Beta Lactam SVP Solutions in Catridges, Syringes and Vials SVP Powders Creams and ointments Hard Gelatin Capsules TabletsNone21st March 2019 Report dateCompliantNasser Lubowa
328IRF/F/100/07/2019 137/GMP/2019 Cert No.Wallace Pharmaceuticals Pvt LimitedBhatian, Nalagarh, Dist. Solan HP 174101, IndiaIndia09/04/201909/04/2022Non-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)None10th July 2019 Report dateCompliantZaidi Mwondha
329IRF/F/022/02/2019 119/GMP/2019 Cert No.Win-Medicare Private LimitedPlot Meerut Muzaffarnager Road, Modipuram- 250 110 Uttar Pradesh, India.India23/11/201823/11/2021Non-beta LactamNon-beta Lactam • Tablets (coated and uncoated) • Hard Gelatin Capsules • SVP Liquids: Ampoules • Powders/granules in sachetsNon-beta Lactam • Tablets (coated and uncoated) • Hard Gelatin Capsules • SVP Liquids: Ampoules • Powders/granules in sachetsNone11th February 2019 Report DateCompliantOkello Andrew
330IRF/F/098/07/2019 133/GMP/2019 Cert No.Wockhardt LimitedBiotech Park, H-14/2, MIDC., Waluj, Aurangabad-431136 Maharashtra IndiaIndia26/04/201926/04/2022Biological productsBiological products: • Small volume parenterals (vials, cartridges and pre-filled syringes)Biological products: • Small volume parenterals (vials, cartridges and pre-filled syringes)None10th July 2019 Report dateCompliantAtumanya Amos
331IRF/F/128/11/2017- R5Wockhardt LimitedPlot 57 Village Kunjhal, Jhamajri, Barotiwala, Baddi, Tehsil-Nalagarh, District Solan, 174103 Himachal Pradesh, IndiaIndia27/10/201727/10/2020Non Beta Lactam• Tablets(Coated and Uncoated) • Hard gelatin capsules • Oral liquids • Creams and ointments• Tablets(Coated and Uncoated) • Hard gelatin capsules • Oral liquids • Creams and ointmentsNoneCompliantNsereko Henry
332IRF/F/218/04/2018 R10 124/GMP/2018Wuhan Fuxing Biopharmaceutical Co., LtdNo.9, Fuxing Road, Hancuan Economic & Development District, Hubei Province, ChinaChina13/03/201813/03/2021Non Beta-lactamNon Beta-lactam • SVP solutions (Ampoules &Vials) aseptically filled/filtered and terminally sterilized. • LVP solutions (Plastic & Glass bottles) Aseptically filled/filtered and terminally sterilizedNon Beta-lactam • SVP solutions (Ampoules &Vials) aseptically filled/filtered and terminally sterilized. • LVP solutions (Plastic & Glass bottles) Aseptically filled/filtered and terminally sterilizedNone13/07/2018 CAPA SUBMITTEDCompliantEtuko Daniel
333IRF/F/374/09/2018 R12 135/GMP/2018Wyeth Pharmaceuticals32, New Lane, Havant, Hampshire, United KingdomUnited Kingdom15/06/2018Non beta-lactam.Non beta-lactam. • Secondary packaging of VaccinesNon beta-lactam. • Secondary packaging of VaccinesNONE07th September 2018 Report DateCompliantWilberforce Kwiringira
334IRF/F/140/11/2017- R6 099/GMP/2018Yeluri Formulations Pvt LtdSy.No. 296/7/6 IDA Bollaram Medak Dist 502 325, IndiaIndia17/10/201717/10/2020Beta lactam dosage forms(penicillin) Beta lactam (cephalosporin)Beta lactam dosage forms(penicillin) Hard gelatin capsules Coated and uncoated tablets Oral dry powder for suspension Beta lactam (cephalosporin) SVP(powders)Beta lactam dosage forms(penicillin) Hard gelatin capsules Coated and uncoated tablets Oral dry powder for suspension Beta lactam (cephalosporin) SVP(powders)None19/01/2018 CAPA SubmittedCompliantOnen Solomon L.
335076/GMP/2019 DRYuria Pharm LLC Manufacturing Site No. 1108, Kobzarska street, Cherkasy, 18030 - UkraineUkraine16/05/201916/05/2022Non-Beta LactamNon-Beta Lactam: LVP Liquids SVP Liquids in Vials Oral LiquidsNon-Beta Lactam: LVP Liquids SVP Liquids in Vials Oral LiquidsNoneCompliantKaleebu Frank
336IRF/F/389/09/2018 R12 205/GMP/2018Zeiss Pharmaceuticals Pvt. LtdPlot No. 72, EPIP I, Jharmajiri, Baddi Himachal Pradesh- IndiaIndia24/07/201824/07/2021Beta Lactam (Cephalosporin) Beta Lactam (Carbapenems)Beta Lactam (Cephalosporin) • SVP Powders Vials Beta Lactam (Carbapenems) • SVP Powders VialsBeta Lactam (Cephalosporin) • SVP Powders Vials Beta Lactam (Carbapenems) • SVP Powders VialsNone21/11/2018 CAPA SUBMITTEDCompliantNasser Lubowa
337IRF/F/162/01/2018- R7 017/GMP/2018 GMP CERTZen Pharma Pvt Ltd.75/1, GIDC. Vapi-396 195 Gujarat, India.India21/11/201721/11/2020Non- Beta lactam Beta lactam cephalosporinNon- Beta lactam; • Small Volume Parenterals (Ampoule and Vial) • External preparations (Ointments and Topical solutions) Beta lactam cephalosporin; • Small Volume Parenterals (Dry powder for Injection)Non- Beta lactam; • Small Volume Parenterals (Ampoule and Vial) • External preparations (Ointments and Topical solutions) Beta lactam cephalosporin; • Small Volume Parenterals (Dry powder for Injection)None06/02/2018 CAPA SUBMITTED 08/02/2018 CAPAEVALUATEDCompliantVictoria Kwesiga
338036/GMP/2019 DRZoetis2000 Rockford Road, Charles City, lowa 50616-9101, United States of America.United States Of America04/02/201904/02/2022Vaccines BiologicalsVaccines Small Volume Parenterals Biologicals Small Volume ParenteralsVaccines Small Volume Parenterals Biologicals Small Volume ParenteralsNoneCompliant
339IRF/F/007/01/2019 013/GMP/2019 GMp Cert No.Zoetis Belgium SARue Laid Burniat 1, Louvain-La-Neuve, 1348, BelgiumBelgium19/10/2018Non-beta lactam Biologicals & VaccinesNon-beta lactam: • SVP liquids packed in vials and prefilled syringes. • SVP lyophilized powders packed in vials. Biologicals & Vaccines: • SVP liquids packed in vials and prefilled syringes. • SVP lyophilized powders packed in vials.Non-beta lactam: • SVP liquids packed in vials and prefilled syringes. • SVP lyophilized powders packed in vials. Biologicals & Vaccines: • SVP liquids packed in vials and prefilled syringes. • SVP lyophilized powders packed in vials.None21/01/2019 Report DateCompliantEtuko Daniel
340IRF/F/431/11/2018 059/GMP/2019 GMP Cert No.Zoetis Industria De Produtos Veterinarios LtdaRua Luiz Fernando Rodriguez 1701-Campinas-Sao Paulo-Brazil.Brazil02/10/2018Immunological productsImmunological products: • Vaccines (Veterinary)Immunological products: • Vaccines (Veterinary)None26th November 2018 Report dateCompliantMutyaba Michael
341IRF/F/305/04/2018 R10 119/GMP/2018Zoetis Manufacturing And Research Spain, S.LCtra. De Camprodin, S/N, Finca La Riba, Vall De Bianya, 17813, Girona Spain.Spain20/03/201820/03/2021Non Beta-lactamNon Beta-lactam • Aseptically filled Small Volume Parenteral • Aseptically filled Small volume parenteral lyophilisate (Poulvac IB QX live vaccine)Non Beta-lactam • Aseptically filled Small Volume Parenteral • Aseptically filled Small volume parenteral lyophilisate (Poulvac IB QX live vaccine)None23rd April 2018 Report dateCompliantKaleebu Frank
342IRF/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-IndiaIndia30/04/201930/04/2022Non ?-lactamNon ?-lactam: Tablets (Coated and uncoated) Capsules (Hard gelatin)Non ?-lactam: Tablets (Coated and uncoated) Capsules (Hard gelatin)None05th July 2019 Report DateCompliantNasser Lubowa
343IRF/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) IndiaIndia03/05/201903/05/2022Beta-Lactam (Cephalosporin)Beta-Lactam (Cephalosporin): Sterile Powder for injection (Aseptically filled)Beta-Lactam (Cephalosporin): Sterile Powder for injection (Aseptically filled)None05th July 2019 Report DateCompliantVictoria Kwesiga
344IRF/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 500078India03/05/201903/05/2022Oncology, 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 producedNone08th August 2019 Report dateCompliantMr. Lubowa Nasser
345IRF/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, IndiaIndia02/04/201902/04/2022Non beta-lactamNon beta-lactam: Tablets, Capsules (hard gelatine)Non beta-lactam: Tablets, Capsules (hard gelatine)None09th August 2019 Report dateCompliantZaidi Mwondha
346IRF/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, IndiaIndia26/03/201926/03/2022Hormones, 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: TabletNone09th August 2019 Report dateCompliantZaidi Mwondha
347IRF/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 IndiaIndia28/06/201928/06/2022Non-beta Lactam (Human)Non-beta Lactam (Human): Oral liquidsNon-beta Lactam (Human): Oral liquidsNone09th August 2019 Report dateCompliantNakimuli Eunice Lukakamwa
348IRF/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 India21/06/201921/06/2022Non-beta LactamNon-beta Lactam: Transdermal PatchesNon-beta Lactam: Transdermal PatchesNone15th August 2019 Report dateCompliantNakimuli Eunice Lukakamwa
349IRF/F/118/08/2019 168/GMP/2019 GMP CertSai Mirra Innopharm Pvt. Limited288 & 299 Sidco Estate, Ambattur, Chennai-600098. IndiaIndia17/05/201917/05/2022Non-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 None15th August 2019 Report dateCompliantFarida Khaukha
350IRF/F/119/08/2019 065/GMP/2020 GMP Cert No.Aurolab - IndiaNo. 1, Sivagangai main road, Veerapanjan, Madurai-625020, Tamil Nadu- IndiaIndia21/06/201921/06/2022Non-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 liquidsNone23rd August 2019 Report dateCompliantAmos Mulera Atumanya
351IRF/F/120/08/2019 183/GMP/2019 Cert No.Micropure Parenterals Private LimitedPlot 136 Neharoli village, Taluka , Wada district, Maharashtra IndiaIndia14/05/201914/05/2022Non-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) – VialsNone23rd August 2019 Report dateCompliantFarida Khaukha
352IRF/F/124/09/2019 Cert No. 012/GMP/2020VHB Medi Sciences LimitedPlot No 20-22 & 49-51 Industrial Estate, Sector 5, Sidcul Rudrapur Uttarakhand, IndiaIndia10/05/201910/05/2022Non-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
None06th September 2019 Report dateCompliantFarida Khaukha
353IRF/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, IndiaIndia21/05/201921/05/2022Non-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)
None06th September 2019 Report dateCompliantFarida Khaukha
354IRF/F/126/09/2019 GMP Cert No. 004/GMP/2020Torque Pharmaceuticals Pvt LimitedUnit 1, Village- Issapur, Post: Dappar, Distt-Mohali, Punjab- 140506, IndiaIndia24/05/201924/05/2022Non-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)None11th September 2019 Report dateCompliantMwesigwa Denis
355IRF/F/127/09/2019 GMP Cert No. 007/GMP/2020Brawn Laboratories Limited13, NIT, Industrial Area, Faridabad- 121001, Haryana, IndiaIndia06/06/201906/06/2022Non-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: 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: Dry powder for oral suspension, SVP-powders, Hard Gelatin capsules. Beta lactam-Penicillin: Dry powder for oral suspension, Hard Gelatin capsulesNone11th September 2019 Report dateCompliantMwesigwa Denis
356IRF/F/128/09/2019 GMp Cert No. 016/GMP/2020Nanz Med Science Pharma Pvt. LimitedRampur Ghat, Paonta Sahib, District Sirmour-173025, Himachal Pradesh, IndiaIndia28/05/201928/05/2022Non-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 powdersNone11th September 2019 Report dateCompliantMwesigwa Denis
357IRF/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)-IndiaIndia31/05/201931/05/2022Non-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.
None11th September 2019 Report dateCompliantMwesigwa Denis
358IRF/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 396210India08/03/201908/03/2022Non-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.
None30th July 2019 Report dateCompliantKenneth Kiiza
359IRF/F/131/07/2019 GMP Cert No. 078/GMP/2020Franco Indian Pharmaceuticals Pvt. Limited54B, Sir M.V. Road, Andheri (E) Mumbai 400-093-IndiaIndia27/08/201927/08/2022Hormones (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).
None20th September 2019 Report dateCompliantKaleebu Frank
360IRF/F/132/09/2019 136/GMP/2019 GMP Cert dateBeacon Pharmaceuticals LimitedKathali, Bhaluka, Mymensingh, BangladeshBangladesh15/05/201915/05/2022Non-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.
None27th September 2019 Report dateCompliantKariuki Gachoki (EAC)
361IRF/F/133/09/2019 173/GMP/2019 Cert No.Alphalytik Pharmaservice GmbhGrunberger Str.44 10245 Berlin, GermanyGermany04/06/201904/06/2022Laboratory testingLaboratory testing: TabletsLaboratory testing: TabletsNone24th September 2019 Report dateCompliantJuliet Awori Okecho
362IRF/F/136/09/2019 GMP Cert No. 024/GMP/2020Liorad LaboratoriesAve.27A, No.26402e/ 264&268 San Agustin. La Lisa, Havana -CubaCuba11/06/201911/06/2022Aseptically 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.None30th September 2019 Report dateCompliantJuliet Awori Okecho
363IRF/F/137/10/2019 GMP Cert No. 033/GMP/2020Rusan Pharma LimitedKhasra No. 122MI, Central Hope Town, Behind Pharma City, Selaqui, Dehradun-248197, Uttarakhand, IndiaIndia21/05/201921/05/2022Non-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 lyophizesNone02nd October 2019 Report dateCompliantDenis William Mwesigwa
364IRF/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, IndiaIndia19/06/201919/06/2022Non-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.None02nd October 2019 Report dateCompliantNakimuli Eunice Lukakamwa
365IRF/F/139/10/2019 GMP Cert No. 039/GMP/2020Human Biologicals Institute (A division of Indian Immunologicals Limited)Rakshapuram, Gachibowli post, Hyderabad- 500032, Telangana, IndiaIndia04/07/201904/07/2022VaccinesVaccines: 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)None03rd October 2019 Report dateCompliantAmos Mulera Atumanya
366IRF/F/140/10/2019 GMP Cert No. 022/GMP/2020Artepharm Company LimitedFengshun Economic and Technological Development Zone Industrial Park, Meizhou, Guangdon, ChinaChina17/05/201917/05/2022Non-beta lactamNon-beta lactam: Tablets (coated and uncoated)Non-beta lactam: Tablets (coated and uncoated)None03rd October 2019 Report dateCompliantMichael Romeo Mutyaba
367IRF/F/143/10/2019 002/GMP/2020 Cert No.Modi-Mundipharma Private LimitedMeerut- Muzaffamagar Road, Modipuram - 250110, U.P. IndiaIndia25/06/201925/06/2022Non-beta lactam (Human)Non-beta lactam (Human): TabletsNon-beta lactam (Human): TabletsNone04th October 2019 Report dateCompliantNakimuli Eunice Lukakamwa
368IRF/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, IndiaIndia30/08/201930/08/2022Non-beta lactamNon-beta lactam: Tablets, Hard gelatin capsulesNon-beta lactam: Tablets, Hard gelatin capsulesNone04th October 2019 Report dateCompliantKaleebu Frank
369087/GMP/2019 DRHelsin Birex Pharmaceuticals LimitedDamastown, Mulhuddart, Dublin 15 - IrelandIreland05/06/201905/06/2022Secondary Packaging Chemical/Physical testingSecondary Packaging Chemical/Physical testingSecondary Packaging Chemical/Physical testingNoneCompliantAmos Mulera Atumanya
370088/GMP/2019 DRLek Pharmaceuticals d. d., Lendava Solids SiteTrimlini 2D, 9220 Lendava – SloveniaSlovenia05/06/201905/06/2022Non-Beta LactamNon-Beta Lactam: Tablets
Hard gelatin capsules
Soft gelatin capsules
Non-Beta Lactam: Tablets
Hard gelatin capsules
Soft gelatin capsules
NoneCompliantAmos Mulera Atumanya
371089/GMP/2019 DRActavis LimitedBLB015-016, Bulebel Industrial Estate, Zejtun ZTN3000 Malta Germany06/06/201906/06/2022Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneCompliantAmos Mulera Atumanya
372094/GMP/2019 DRSanofi Winthdrop Industrie56, route de Choisy au Bac – 60205 Compiegne, France France14/06/201914/06/2022CephalosporinCephalosporin: Tablets,
Other solid dosage forms
Cephalosporin: Tablets,
Other solid dosage forms
NoneCompliantKaleebu Frank
373095/GMP/2019 DRSANOFI PASTEUR - Marcy l'etoileCampus Merieux 1541 avenue marcel merieux 69280, Marcy l'etoile - FranceFrance06/06/201906/06/2022SVP Liquids (Non-Beta Lactam)SVP Liquids (Non-Beta Lactam): VaccinesSVP Liquids (Non-Beta Lactam): VaccinesNoneCompliantKaleebu Frank
374096/GMP/2019 DRWest-Ward Columbus Inc1809 Wilson Road, Columbus Ohio 43228 – USAUnited States Of America19/06/201919/06/2022Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneCompliantKaleebu Frank
375097/GMP/2019 DRSiegfried Hameln GmbHLanges Feld 13, 31789 Hameln - GermanyGermany20/06/201920/06/2022Non-Beta LactamNon-Beta Lactam: SVP Liquids in Ampoules & Vials,
LVP Liquids
Non-Beta Lactam: SVP Liquids in Ampoules & Vials,
LVP Liquids
NoneCompliantEmurwon Kosiya
376098/GMP/2019 DRGlaxoSmithKline BiologicalsRue de l'institut 89 - 1330 Rixensart - BelgiumBelgium20/06/201920/06/2022Non-Beta LactamNon-Beta Lactam: SVP Liquids in Vials, LVP Liquids, SVP Lyophilisates
Non-Beta Lactam: SVP Liquids in Vials, LVP Liquids, SVP Lyophilisates
NoneCompliantEmurwon Kosiya
377099/GMP/2019 DRKaiseraugst (Pharma)CH 4303 Kaiseraugst, Wurmisweg - SwitzerlandSwitzerland25/06/201925/06/2022Non-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
NoneCompliantKaleebu Frank
378105/GMP/2019 DRSofarimex Industria Quimica e Farmaceutica, S. A.Av das Industrias-Alto do Colaride, 2735-213 Agualva Cacem - PortugalPortugal10/07/201910/07/2022Non-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
NoneCompliantEmurwon Kosiya
379110/GMP/2019 DRBoehringer Ingelheim Pharma GmbH and Company KGBinger Str. 173,55216 Ingelheim Am Rhein - GermanyGermany22/07/201922/07/2022Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsule
Metered Dose Inhalers
Non-Beta Lactam: Tablets
Hard Gelatin Capsule
Metered Dose Inhalers
NoneCompliantEmurwon Kosiya
380125/GMP/2019 DRAbbVie, Inc (North Chicago Facility)1401 Sheridan Road, North Chicago, IL 60064-4000United States Of America08/09/201908/09/2022Animal Extracted ProductsAnimal Extracted Products: Intratracheal SuspensionsAnimal Extracted Products: Intratracheal SuspensionsNoneCompliantEmurwon Kosiya
381126/GMP/2019 DRBoehringer Ingelheim Ellas AE5th km Paiania – Markopoulo, Koropi Attiki, 19400 - GreeceGreece08/09/201908/09/2022Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneCompliantEmurwon Kosiya
382132/GMP/2019 DRBesins Manufacturing Belgium (BMB)Groot Bijgaardenstraat, 128. 1620 Drogenbos - BelgiumBelgium10/09/201910/09/2022Non ?-lactam (Hormones)Non ?-lactam (Hormones): Semi-solid gelsNon ?-lactam (Hormones): Semi-solid gelsNoneCompliantAmos Mulera Atumanya
383142/GMP/2019 DRV.M.D. n.v.Hoge Mauw 900 – 2370 ArendonkBelgium04/10/201904/10/2022Non ?-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.
NoneCompliantEmurwon Kosiya
384144/GMP/2019 DRHerd Mundy Richardson LimitedOak House, Bredbury Park way, Ashton Road, Bredbury, Stockport, SK6 2SN – United KingdomUnited Kingdom07/10/201907/10/2022HormonesHormones: GelsHormones: GelsNoneCompliantEmurwon Kosiya
385145/GMP/2019 DRCentral Pharma (Contract Packing) LimitedCaxton Road, Bedford, MK41 OXZ – United KingdomUnited Kingdom07/10/201907/10/2022HormonesHormones: GelsHormones: GelsNoneCompliantEmurwon Kosiya
386IRF/F/147/10/2019 GMP Cert No. 043/GMP/2020Shanghai Desano Biopharmaceutical Company Limited1479 Zhangheng Road, Shanghai, ChinaChina14/05/201914/05/2022Non-beta lactamTablets, Hard gelatin capsulesTablets, Hard gelatin capsulesNone08th October 2019 Report DateCompliantOkello Andrew
387IRF/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.India07/09/201907/09/2022Steroidal 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 suspensionsNone14th October 2019 Report DateCompliantKaleebu Frank
388IRF/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, IndiaIndia03/07/201903/07/2022Non-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 None14th October 2019 Report DateCompliantNakimuli Eunice Lukakamwa
389IRF/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. ChinaChina11/05/201911/05/2022Non-beta lactamLiquids for external use (acaricide), Liquids for internal use, Powder – PremixLiquids for external use (acaricide), Liquids for internal use, Powder – PremixNone17th October 2019 Report DateCompliantOkello Andrew
390IRF/F/151/10/2019 GMP Cert No. 014/GMP/2020Elanco (Shanghai) Animal Health Limited1 Changzhong Road, Wusi Farm, Fengxian District, Shanghai 201423, ChinaChina06/08/201906/08/2022Non-beta lactamOral Veterinary Powder, Oral Veterinary PremixesOral Veterinary Powder, Oral Veterinary PremixesNone17th October 2019 Report DateCompliantWilberforce Kwiringira
391IRF/F/154/11/2019 GMP Cert No. 041/GMP/2020Aurochem Laboratories (I) Pvt LimitedPlot 08 Palghar 40104 Maharashtra, IndiaIndia24/09/201924/09/2022Non-beta lactamNon-beta lactam: Oral liquid line, External creams and ointmentsNon-beta lactam: Oral liquid line, External creams and ointmentsNone20th November 2019 Report dateCompliantNahamya David
392IRF/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, IndiaIndia17/09/201917/09/2022Non-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 liquidsNone20th November 2019 Report dateCompliantNahamya David
393IRF/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, IndiaIndia20/09/201920/09/2022Non-beta lactamTablets, Hard gelatin capsules, Soft gelatin capsulesTablets, Hard gelatin capsules, Soft gelatin capsulesNone21st November 2019 Report dateCompliantNahamya David
394IRF/F/159/11/2019 099/GMP/2020 GMP Cert No.Aculife Healthcare Pvt LimitedVillage Sachana, Taluka, Viramgam, Dist. Ahmedabad 382150, Gujarat - India India17/09/201917/09/2022Non-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 filledNone28th November 2019 Report dateCompliantEtuko Daniel
395IRF/F/162/11/2019 066/GMP/2020 GMP Cert No.Asiatic Agricultural Industries Pte. Limited150 Gul Circle Singapore 629607Singapore15/10/201915/10/2022EctoparasiticideEctoparasiticide: SolutionEctoparasiticide: SolutionNone29th November 2019 Report dateCompliantMwesigwa Denis
396IRF/F/163/11/2019 048/GMP/2020 GMP Cert No.Hebei Bimeda Pharmaceutical Technology Company LimitedNo.60, Ganjiang Road Shijiazhuang Economic & Technological Development ZoneChina18/10/201918/10/2022Non-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 InjectionNone29th November 2019 Report dateCompliantMwesigwa Denis
397IRF/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. ChinaChina23/10/201923/10/2022Non-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, GranulesNone29th November 2019 Report dateCompliantMwesigwa Denis
398IRF/F/166/12/2019 174/GMP/2019 GMP Cert No.Indoco Remedies Limited - Unit IIL-32,33,34, Verna Industrial Area, Verna GOA 403722 - IndiaIndia30/08/201930/08/2022Non-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)None03rd November 2019 Report dateCompliantZaidi Mwondha
399IRF/F/168/12/2019 078/GMP/2020 GMP Cert No.Medreich Limited India - Unit 112th Mile, Old Madras Road, Virgonagar, 560049 BangaloreIndia07/09/201907/09/2022Beta 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 suspensionNone03rd November 2019 Report dateCompliantZaidi Mwondha
400IRF/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) IndiaIndia17/09/201917/09/2022Non-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 suspensionNone11th December 2019 Report dateCompliantLukwago Mohammad
401IRF/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, IndiaIndia10/09/201910/09/2022Non-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)None11th December 2019 Report dateCompliantLukwago Mohammad
402IRF/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, IndiaIndia30/09/201930/09/2022Non ?-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 InjectionNone11th December 2019 Report dateCompliantNahamya David
403IRF/F/174/12/2019 GMP Cert No. 061/GMP/2020AMN Life Science Pvt Limited67/P-1 Malav, Area-Bhilad, Valsad-39105, Gujarat, IndiaIndia27/09/201927/09/2022?-lactam?-lactam: Tablets, Hard Gelatin Capsules, Powder for oral suspension?-lactam: Tablets, Hard Gelatin Capsules, Powder for oral suspensionNone11th December 2019 Report dateCompliantNahamya David
404IRF/F/060/04/2019 156/GMP/2019 Cert No.Shaigan Pharmaceuticals (Pvt.) Limited14 Km, Adyala road post office Dahgal, Rawalpindi, PakistanPakistan27/11/201827/11/2021Non-beta lactam, Cephalosporin, HormonesNon-beta lactam: Tablet (Coated and Uncoated), Hard gelatin capsules, Dry powder for oral suspension, Oral liquid preparations, Small Volume parenteral – Lyophilized powder, Small Volume parenteral – Terminally sterilized, Small Volume parenteral – Ophthalmic solution aseptically prepared
Cephalosporin: Dry powder for oral suspension, Hard gelatin capsules, Dry powder for injection- small volume vials
, Hormones: Tablets, Small volume parenterals – Aseptically prepared, Small Volume parenterals – Lyophilized powder, Creams and lotions
Non-beta lactam: Tablet (Coated and Uncoated), Hard gelatin capsules, Dry powder for oral suspension, Oral liquid preparations, Small Volume parenteral – Lyophilized powder, Small Volume parenteral – Terminally sterilized, Small Volume parenteral – Ophthalmic solution aseptically prepared
Cephalosporin: Dry powder for oral suspension, Hard gelatin capsules, Dry powder for injection- small volume vials
, Hormones: Tablets, Small volume parenterals – Aseptically prepared, Small Volume parenterals – Lyophilized powder, Creams and lotions
None01st April 2019 Report dateCompliantMwesigwa Denis
405158/GMP/2019 DRRubiepharm Arzneimettel GmbHBruder-Grimm-Str. 62, 36396 Steinau a. d. StraBe-GermanyGermany12/11/201912/11/2022Non-Beta LactamNon-Beta Lactam: SuppositoriesNon-Beta Lactam: SuppositoriesNoneCompliantKaleebu Frank
406159/GMP/2019 DRSalutas Pharma GmbHOtto-von-Guericke Alle 1, D-39179 Barleben – GermanyGermany12/11/201912/11/2022Non-Beta LactamNon-Beta Lactam: Hard Gelatin Capsules
Tablets
Non-Beta Lactam: Hard Gelatin Capsules
Tablets
NoneCompliantKaleebu Frank
407160/GMP/2019 DRThe Mentholatum Company Limited1 Redwood Avenue, Peel Park Campus, East Kilbride - ScotlandScotland12/11/201912/11/2022Non-Beta LactamNon-Beta Lactam: Semi solids (Creams, Ointments, Gels)Non-Beta Lactam: Semi solids (Creams, Ointments, Gels)NoneCompliantKaleebu Frank
408161/GMP/2019 DRJanssen Ortho LLCState Road 933 Km 0.1, Mamey Ward, Gurabo, Puerto Rico 00778 – United States of AmericaUnited States Of America12/11/201912/11/2022Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneCompliantKaleebu Frank
409162/GMP/2019 DRAcino Pharma AGDornacherstrasse 114; 4147 Aesch - SwitzerlandSwitzerland12/11/201912/11/2022Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
NoneCompliantKaleebu Frank
410163/GMP/2019 DRS. M. Farmaceutici S.r.l.Zona Industriale – 85050 Tito (PZ) - ItalyItaly13/11/201913/11/2022Non-Beta LactamNon-Beta Lactam: SVP Liquids in vials
LVP Liquids
Non-Beta Lactam: SVP Liquids in vials
LVP Liquids
NoneCompliantKaleebu Frank
411164/GMP/2019 DRSanofi Winthrop Industrie180 rue Jean Jaures, 94700 Maisons – Alfort, FranceFrance13/11/201913/11/2022BiologicalsBiologicals: Prefilled SyringesBiologicals: Prefilled SyringesNoneCompliantKaleebu Frank
412167/GMP/2019 DRColep Laupheim GmbH and Company KGFockestrasse 12, 88471 Laupheim - GermanyGermany11/11/201911/11/2022Non-Beta LactamNon-Beta Lactam: Pressurised preparations (Inhalers)Non-Beta Lactam: Pressurised preparations (Inhalers)NoneCompliantKaleebu Frank
413001/GMP/2020 DRSandoz GmbHBiochemiestrasse 10, A-6250 Kundl - AustriaAustria02/01/202002/01/2023CephalosporinCephalosporin: Tablets,Hard Gelatin CapsulesCephalosporin: Tablets,Hard Gelatin CapsulesNoneCompliantKitimbo Brenda Clare
414IRF/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 - IndiaIndia05/09/201905/09/2022VaccineVaccine: Small Volume Parenteral Solution, in glass vialsVaccine: Small Volume Parenteral Solution, in glass vialsNone16th December 2019 Report dateCompliantAndrew Okello Okonye
415IRF/F/002/01/2020 008/GMP/2020 GMP Cert No.Sovereign Pharma Private LimitedSurvey No. 46/1-4, Kadaiya village, Nani Daman – 396210, IndiaIndia20/09/201920/09/2022Non ?-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 vialsNone14th January 2020 Report dateCompliantNambasa Victoria
416IRF/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 - IndiaIndia17/09/201917/09/2022Non ?-lactam, HormonesNon ?-lactam: Tablets
(coated and uncoated)
, Hormones: Tablets
(coated and uncoated)
Non ?-lactam: Tablets
(coated and uncoated)
, Hormones: Tablets
(coated and uncoated)
None14th January 2020 Report dateCompliantNambasa Victoria
417IRF/L/009/01/2020 067/GMP/2020 GMP Cert No.Lifeway Pharmaceutical Industries LimitedBlock 198, Plot 478 Nangwa Mukono_UgandaUganda03/11/201903/11/2022Non-Beta LactamNon-Beta Lactam: Tablets (Coated and Uncoated), Capsule (Hard gelatin)Non-Beta Lactam: Tablets (Coated and Uncoated), Capsule (Hard gelatin)None14th January 2020 Report dateCompliantMwesigwa Denis
418IRF/F/010/01/2020 097/GMP/2020 GMP Cert No.Apex Laboratories Pvt. Limited - Plant 1B-23, SIDCO Pharmaceutical Complex Alathur, Kancheepuram District 603,IndiaIndia10/09/201910/09/2022Non-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
None15th January 2020 Report dateCompliantZaidi Mwondha
419IRF/L/013/01/2020 056/GMP/2020 GMP Cert datePanacea Biotec LimitedMalpuri Baddi, District Solan, Himachal Pradesh-173205 - IndiaIndia13/09/201913/09/2022Non-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
None20th January 2020 Report dateCompliantKenneth Kiiza
420IRF/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, TurkeyTurkey08/11/201908/11/2022Beta lactam (cephalosporin)Beta lactam (cephalosporin): TabletsBeta lactam (cephalosporin): TabletsNone20th January 2020 Report dateCompliantJuliet Awori Okecho
421IRF/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 TurkeyTurkey05/11/201905/11/2022Non 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 None20th January 2020 Report dateCompliantJuliet Awori Okecho
422IRF/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, TurkeyTurkey12/11/201912/11/2022Non 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)None20th January 2020 Report dateCompliantJuliet Awori Okecho
423IRF/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, ChinaChina02/11/201902/11/2022Non 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)
None21st January 2020 Report dateCompliantMwesigwa Denis
424IRF/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 ChinaChina12/10/201912/10/2022Cephalosporin, 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
None06th February 2020 Report dateCompliantNasser Lubowa
425IRF/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 ChinaChina09/10/201909/10/2022Non ?-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 VialsNone06th February 2020 Report dateCompliantNasser Lubowa
426IRF/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 Korea15/10/201915/10/2022Non ?-lactam: Tablets (Coated and Uncoated)Non ?-lactam: Tablets (Coated and Uncoated)Non ?-lactam: Tablets (Coated and Uncoated)None06th February 2020 Report dateCompliantNasser Lubowa
427IRF/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, IndiaIndia25/09/201925/09/2022Non-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
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
None14th February 2019 and 07th February 2020 Report datesCompliantMs. Annette .B. Ssenkindu and Kenneth Kiiza
428IRF/F/036/02/2020 080/GMP/2020 GMP Cert No.Acme Formulations Private LimitedRopar Road, Nalagarh, Distt. Solan , Himachal Pradesh -174 101; Baddi, IndiaIndia15/11/201915/11/2022Non 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 capsulesNone11th February 2020 Report dateCompliantAnnet Ssekindu
429IRF/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 IndiaIndia12/11/201912/11/2022Non-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 CreamsNone18th February 2020 Report dateCompliantAmos Mulera Atumanya
430IRF/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 Arabia24/11/201924/11/2022Non-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 solutionNone19th February 2020 Report dateCompliantVictoria Kwesiga
431IRF/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-411057India19/11/201919/11/2022Biologicals, 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)None21st February 2020 Report dateCompliantAmos Mulera Atumanya
432IRF/F/047/02/2020 Cert No. 030/GMP/2020Glenmark Pharmaceuticals LimitedPlot No. S - 7, Colvale Industrial Estate, Colvale, Bardez 403513, Goa, IndiaIndia22/11/201922/11/2022Non-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 CreamsNone21st February 2020 Report dateCompliantAmos Mulera Atumanya
433IRF/F/049/02/2020 053/GMP/2020 GMP Cert No.Zeiss Pharma Limited (Unit II)IGP, SIDCO, Phase II, Samba, Jammu - 184121, (J&K), IndiaIndia17/09/201917/09/2022CephalosporinCephalosporin: Tablet, Sterile Powder for Injection (in glass vials), Powder for Oral SuspensionCephalosporin: Tablet, Sterile Powder for Injection (in glass vials), Powder for Oral SuspensionNone21st February 2020 Report dateCompliantSsali Peter
434IRF/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: 3570Palestine22/08/201922/08/2022Oral 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 vialsNone24th February 2020 Report dateCompliantEAC Team
435IRF/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 PalestinePalestine20/08/201920/08/2022Sterile 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, TabletsNone24th February 2020 Report dateCompliantEAC Team
436IRF/F/054/02/2020 GMP Cert No. 035/GMP/2020Boehringer Ingelheim Pharma GmbH and Company KGBinger Straße 173, 55216 Ingelheim am Rhein, GermanyGermany13/12/201913/12/2022Non-beta lactamNon-beta lactam: Aseptically prepared solutions for inhalation (Respimat), Soft gelatin capsulesNon-beta lactam: Aseptically prepared solutions for inhalation (Respimat), Soft gelatin capsulesNone27th February 2020 Report dateCompliantOnen Solomon L.
437IRF/F/055/02/2020 GMP Cert No. 036/GMP/2020Corden Pharma GmbHOtto-Hahn Strasse, 68723 Plankstadt- GermanyGermany06/12/201906/12/2022Oncology, HormonesOncology: Tablets, Hormones: TabletsOncology: Tablets, Hormones: TabletsNone27th February 2020 Report dateCompliantOnen Solomon L.
438IRF/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 - IndiaIndia06/09/201906/09/2022VaccineVaccine: Small Volume Parenteral Solution, in glass vialsVaccine: Small Volume Parenteral Solution, in glass vialsNone10th March 2020 Report dateCompliantAndrew Okello Okonye
439IRF/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 ChinaChina29/10/201929/10/2022Non-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)
None12th March 2020 Report dateCompliantMwesigwa Denis
440IRF/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, EgyptEgypt19/11/201919/11/2022Beta-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)
None12th March 2020 Report dateCompliantVictoria Kwesiga
441005/GMP/2020 DRSchering Plough Labo NVHeist-op-den-Berg BelgiumBelgium09/01/202009/01/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneCompliantKaleebu Frank
442013/GMP/2020 DRMedochemie Limited (Cogols Facility)1-10 Constantinoupoleos Street, 3011 Limassol - CyprusCyprus24/01/202024/01/2023Non-Beta LactamNon-Beta Lactam: Oral Liquids
Suppositories
Semi-solids
Non-Beta Lactam: Oral Liquids
Suppositories
Semi-solids
NoneCompliantKaleebu Frank
443020/GMP/2020 DRInterchemie werken “De Adelaar” B. VMetaalweg 8, 5804 CG Venray, The NetherlandsThe Netherlands12/02/202012/02/2023Non-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)
NoneCompliantKaleebu Frank
444021/GMP/2020 DRInterchemie Werken "De Adelaar" Eesti ASVanapere tee 14, Puunsi village, 74013 Viimsi, Harjumaa - EstoniaEstonia12/02/202012/02/2023Non-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
NoneCompliantKaleebu Frank
445026/GMP/2020 DREurofins Lancaster Laboratories Inc.2425 New Holland pike, Pennsylvania, 17601 - United StatesUnited States Of America21/02/202021/02/2023Vaccines (ERVEBO)Vaccines (ERVEBO): SVP Liquids in vialsVaccines (ERVEBO): SVP Liquids in vialsNoneCompliantKaleebu Frank
446027/GMP/2020 DRBioReliance Corporation9900 Blackwell Road, Rockville Maryland 20850 - 3349 - United StatesUnited States Of America21/02/202021/02/2023Vaccines (ERVEBO)Vaccines (ERVEBO): SVP Liquids in vialsVaccines (ERVEBO): SVP Liquids in vialsNoneCompliantKaleebu Frank
447028/GMP/2020 DRBioReliance Corporation9610 Medical Center Drive, Rockville Maryland 20850 - 3349 - United States United States Of America21/02/202021/02/2023Vaccines (ERVEBO)Vaccines (ERVEBO): SVP Liquids in vialsVaccines (ERVEBO): SVP Liquids in vialsNoneCompliantKaleebu Frank
448029/GMP/2020 DRMSD Site – Burgwedel Biotech GmbHIm Langen Felde 5, 30938 Burgwedel - GermanyGermany21/02/202021/02/2023Vaccines (ERVEBO)Vaccines (ERVEBO): SVP Liquids in vialsVaccines (ERVEBO): SVP Liquids in vialsNonwCompliantKaleebu Frank
449034/GMP/2020 DREsapharm s.r.l.Via A. De Gasperi, 13 20066 Melzo (Milan) - Italy.Italy25/02/202025/02/2023Non-Beta LactamNon-Beta Lactam: Semi - SolidsNon-Beta Lactam: Semi - SolidsNoneCompliantKaleebu Frank
450IRF/F/065/05/2020 GMP Cert No. 046/GMP/2020Haupt Pharma Amareg GmbHDonaustaufer Str. 378, D-93055 Regensburg- GermanyGermany17/12/201917/12/2022OncologyOncology: Hard gelatin capsulesOncology: Hard gelatin capsulesNone04th May 2020 Report dateCompliantOnen Solomon L.
451044/GMP/2020 DRSanofi Winthrop Industrie TOURS30-36 Avenue Gustave Eiffel 37100 Tours FranceFrance19/05/202019/05/2023Non- Beta LactamNon- Beta Lactam: TabletsNon- Beta Lactam: TabletsNoneCompliantKaleebu Frank
452058/GMP/2020 DRSchering – Plough Labo nvIndustriepark 30 – Zone A, 2220 Heist-op-den-Berg - BelgiumBelgium05/06/202005/06/2023Non- 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
NoneCompliantKaleebu Frank
453IRF/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 Rico11/02/202011/02/2023Non- Beta LactamNon- Beta Lactam: Tablets (Coated and Uncoated)Non- Beta Lactam: Tablets (Coated and Uncoated)None24th June 2020 Report dateCompliantNasser Lubowa
454063/GMP/2020 EAC InspectionBoehringer Ingelheim Animal HealthS.P.A. Via Baviera 9, Noventa Padova, Padova, Italy - 35027Italy25/10/201925/10/2022Inactivated 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)NoneCompliantAmoreen Naluyima
455064/GMP/2020 EAC InspectionElanco Animal Health also known as Lohmann Animal Health GmbHHenz-Lohmann-Strasse 4, 27472 Cuxhaven; Lower Saxony, Federal Republic of GermanyGermany29/10/201929/10/2022Live 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)NoneCompliantAmoreen Naluyima
456069/GMP/2020 DRUnither Liquid Manufacturing1-3, allee de la Neste – Z.I d’ en Sigal 31770 Colomiers - FranceFrance24/06/202024/06/2023Non-Beta LactamNon-Beta Lactam: Liquids for external use, Oral Liquids, Suppositories
Non-Beta Lactam: Liquids for external use, Oral Liquids, Suppositories
NoneCompliantKaleebu Frank
457070/GMP/2020 DRBayer OyOfficial address: P.O Box 415 FI-20101 Turku, Street address: Pansionatie 47 FIN-20210Turku, FinlandFinland29/06/202029/06/2023HormonesHormones: Solids and implants, Intra uterine devicesHormones: Solids and implants, Intra uterine devicesNoneCompliantKaleebu Frank
458071/GMP/2020 DRDelorbis Pharmaceuticals Limited17, Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia – CyprusCyprus30/06/202030/06/2023Non-Beta LactamNon-Beta Lactam: Tablets, Hard gelatin capsulesNon-Beta Lactam: Tablets, Hard gelatin capsulesNoneCompliantKaleebu Frank
459075/GMP/2020 GMP Cert No (EAC Inspection by Tanzania and Burundi)Ajanta Pharma LimitedMirza - Palashbari Road, Village - Kokjhar, Palashbari – 781128 Kamrup (R. Assam) IndiaIndia03/05/201903/05/2022Non-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)
NoneEAC Report discussed in TanzaniaCompliantTanzania
460083/GMP/2020 DRRottendorf Pharma GmbHOstenfelder Strasse 51-61 Ennigerloh - GermanyGermany30/07/202030/07/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneCompliantKaleebu Frank
461084/GMP/2020 DRNovartis Farma S.p.AVia Provinciale Schito 131,80058 Torre Annunziata - ItalyItaly30/07/202030/07/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneCompliantKaleebu Frank
462085/GMP/2020 DRLek S. A.Domaniewska Str. 50 C, 02-672 Warsaw - PolandPoland30/07/202030/07/2023Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
NoneCompliantKaleebu Frank
463086/GMP/2020 DRGlaxoSmithKline Dungarvan LimitedKnockbrack, Dungarvan, Co. Waterford – IrelandIreland30/07/202030/07/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneCompliantKaleebu Frank
464087/GMP/2020 DRF. Hoffmann – La Roche KaiseraugstWurmisweg CH – 4303 Basel – SwitzerlandSwitzerland30/07/202030/07/2023Biotechnology 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
NoneCompliantKaleebu Frank
465088/GMP/2020 DRRottendorf Pharma GmbHAm Fleigendahl 3, 59320 Ennigerloh – GermanyGermany30/07/202030/07/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneCompliantKaleebu Frank
466089/GMP/2020 DRAllphamed PHARBIL Arzneimittel GmbHHildebrandstr. 10-12, 37081 Gottingen – GermanyGermany30/07/202030/07/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneCompliantKaleebu Frank
467092/GMP/2020 DRSanofi Pasteur (Swiftwater)1 Discovery Drive, Swiftwater, PA, 18370 - United States of AmericaUnited States Of America11/08/202011/08/2023Vaccines (Menactra)Vaccines (Menactra): Small Volume LiquidsVaccines (Menactra): Small Volume LiquidsNoneCompliantKaleebu Frank
468093/GMP/2020 DRAbic Biological Laboratories Limited3 Hamelacha st., West Industrial zone, Beit-Shemesh 9905503 - IsraelIsrael11/08/202011/08/2023VaccinesVaccines: Large Volume Liquids, SVP Liquids in Vials, SVP Lyophilisates, TabletsVaccines: Large Volume Liquids, SVP Liquids in Vials, SVP Lyophilisates, TabletsNoneCompliantKaleebu Frank
469094/GMP/2020 DRAbbVie Deutschland GmbH & Company KG50 Knollstrasse, D-67061, Ludwigshafen - GermanyGermany11/08/202011/08/2023Non-Beta LactamNon-Beta Lactam: TabletsNon-Beta Lactam: TabletsNoneCompliantKaleebu Frank
470095/GMP/2020 DRFARMACLAIR440, Avenue du General de Gaulle 14200 Herouville-Saint Clair - FranceFrance11/08/202011/08/2023Non-Beta LactamNon-Beta Lactam: Oral Liquids, Oral SuspensionsNon-Beta Lactam: Oral Liquids, Oral SuspensionsNoneCompliantKaleebu Frank
471098/GMP/2020 DRLek S. A.Podlipie Str. 16, 95-010 Stryykow - PolandPoland21/08/202021/08/2023Non-Beta LactamNon-Beta Lactam: Tablets
Hard Gelatin Capsules
Non-Beta Lactam: Tablets
Hard Gelatin Capsules
NoneCompliantKaleebu Frank