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List of Certificates of Suitability (CEPs) for Esomeprazole Magnesium Dihydrate Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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01 2MINAKEM Dunkerque FR

02 2METROCHEM API PRIVATE LIMITED Hyderabad IN

03 3DR. REDDY'S LABORATORIES LIMITED Hyderabad IN

04 2APITORIA PHARMA PRIVATE LIMITED Hyderabad IN

05 1CHROMO LABORATORIES INDIA PRIVATE LIMITED Pashamylaram IN

06 2CIPLA LIMITED Mumbai IN

07 1EVEREST ORGANICS LIMITED Aroor Village IN

08 1F.I.S. - Fabbrica Italiana Sintetici S.p.A. Montecchio Maggiore IT

09 1GLENMARK LIFE SCIENCES LIMITED Mumbai IN

10 1GRANULES INDIA LIMITED Hyderabad IN

11 1HEC PHARM CO., LTD. Yidu City CN

12 2HETERO DRUGS LIMITED Hyderabad IN

13 1JIANGSU ZHONGBANG PHARMACEUTICAL CO., LTD. Gaochun CN

14 2JUBILANT PHARMOVA LIMITED Nanjangud IN

15 1KRKA, d.d., Novo mesto Novo mesto SI

16 2LEE PHARMA LIMITED Hyderabad IN

17 1LUPIN LIMITED Mumbai IN

18 2MSN LIFE SCIENCES PRIVATE LIMITED Chandampet Village IN

19 1NIFTY LABS PVT. LTD. Hyderabad IN

20 1NINGBO MENOVO PHARMACEUTICAL CO., LTD. Ningbo CN

21 1NINGBO MENOVO PHARMACEUTICAL CO., LTD. Ningbo Hi-Tech District CN

22 5NOSCH LABS PRIVATE LIMITED Hyderabad IN

23 1PCAS Ecully FR

24 1QILU PHARMACEUTICAL CO., LTD. Jinan CN

25 3SHOUGUANG FUKANG PHARMACEUTICAL CO., LTD. Shouguang City CN

26 1SRINI PHARMACEUTICALS PRIVATE LIMITED Choutuppal IN

27 1Sandoz Syntek Ilaç Hammaddeleri Sanayi Ve Ticaret A.S. Istanbul TR

28 2TIANISH LABORATORIES PRIVATE LIMITED Hyderabad IN

29 1Union Quimico Farmaceutica, S.A. (Uquifa S.A.) Barcelona ES

30 1VASUDHA PHARMA CHEM LIMITED Hyderabad IN

31 1ZHEJIANG HUAYI PHARMACEUTICAL CO., LTD. Yiwu CN

32 1ZYDUS LIFESCIENCES LIMITED Vadodara IN

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PharmaCompass
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

R1-CEP 2012-256 - Rev 02
Valid
Chemical
2021-06-03
2372
Minakem Comapny Banner

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

Esomeprazole magnesium trihydrate, Micronised, non-micronised

Certificate Number : R1-CEP 2012-256 - Rev 02

Status : Valid

Issue Date : 2021-06-03

Type : Chemical

Substance Number : 2372

Minakem Comapny Banner
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

CEP 2021-022 - Rev 01
Valid
Chemical
2024-06-20
2787
Metrochem

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

Esomeprazole magnesium dihydrate

Certificate Number : CEP 2021-022 - Rev 01

Status : Valid

Issue Date : 2024-06-20

Type : Chemical

Substance Number : 2787

Metrochem
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

R0-CEP 2023-070 - Rev 00
Valid
Chemical
2023-06-15
2372
Dr Reddy Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Esomeprazole magnesium trihydrate, EMT-2 Process

Certificate Number : R0-CEP 2023-070 - Rev 00

Status : Valid

Issue Date : 2023-06-15

Type : Chemical

Substance Number : 2372

Dr Reddy Company Banner
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

R1-CEP 2015-086 - Rev 00
Valid
Chemical
2020-08-31
2787
Minakem Comapny Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

Esomeprazole magnesium dihydrate, Micronised, non-micronised

Certificate Number : R1-CEP 2015-086 - Rev 00

Status : Valid

Issue Date : 2020-08-31

Type : Chemical

Substance Number : 2787

Minakem Comapny Banner
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

CEP 2020-386 - Rev 02
Valid
Chemical
2024-08-26
2372
Metrochem

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

Esomeprazole magnesium trihydrate

Certificate Number : CEP 2020-386 - Rev 02

Status : Valid

Issue Date : 2024-08-26

Type : Chemical

Substance Number : 2372

Metrochem
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

R0-CEP 2021-243 - Rev 00
Valid
Chemical
2022-01-03
2372
Dr Reddy Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Esomeprazole magnesium trihydrate, Process II

Certificate Number : R0-CEP 2021-243 - Rev 00

Status : Valid

Issue Date : 2022-01-03

Type : Chemical

Substance Number : 2372

Dr Reddy Company Banner
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

R1-CEP 2012-395 - Rev 01
Valid
Chemical
2023-06-05
2372
Dr Reddy Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Esomeprazole magnesium trihydrate

Certificate Number : R1-CEP 2012-395 - Rev 01

Status : Valid

Issue Date : 2023-06-05

Type : Chemical

Substance Number : 2372

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