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List of Drug Master Files (DMF) of Esomeprazole Magnesium Dihydrate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 203Xls
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01 2Minakem

02 2Granules India Limited

03 2Metrochem API Private Limited

04 3Dr. Reddy\'s Laboratories

05 2Alkem Laboratories

06 2Aurobindo Pharma Limited

07 1Chromo Laboratories

08 2Cipla

09 1Everest Organics

10 3F.I.S. Fabbrica Italiana Sintetici

11 4Glenmark Life Sciences

12 1HEC Pharm

13 5Hetero Drugs

14 5Jubilant Generics

15 1LONZEAL PHARMACEUTICALS CO LTD

16 1Lee Pharma

17 1Lupin Ltd

18 3MSN Laboratories

19 2Macleods Pharmaceuticals Limited

20 1Murli Krishna Pharma

21 1Ningbo Menovo Pharmaceutical

22 1Perrigo API India Private Limited

23 1RANBAXY LABORATORIES LIMITED

24 2Raks Pharma

25 2Shouguang Fukang Pharmaceutical Co., Ltd

26 1Srini Pharmaceuticals

27 2Sun Pharmaceutical Industries Limited

28 2Torrent Pharmaceuticals Limited

29 1UQUIFA

30 1Vasudha Pharma Chem

31 3Viatris

32 1ZHEJIANG JINHUA CONBA BIO-PHARM. CO., LTD.

33 1Zhejiang Yongtai Technology

34 2Zydus Lifesciences

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 28462

Submission : 2014-07-08

Status : Active

Type : II

Minakem Comapny Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : Complete

Rev. Date : 2023-05-26

Pay. Date : 2023-04-18

DMF Number : 36556

Submission : 2021-12-24

Status : Active

Type : II

Granules India

03

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35400

Submission : 2020-11-28

Status : Active

Type : II

Metrochem

04

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : Complete

Rev. Date : 2013-02-07

Pay. Date : 2013-01-16

DMF Number : 23994

Submission : 2010-07-26

Status : Active

Type : II

Dr Reddy Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : Complete

Rev. Date : 2019-11-25

Pay. Date : 2019-10-16

DMF Number : 34026

Submission : 2019-10-04

Status : Active

Type : II

Minakem Comapny Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37233

Submission : 2022-07-01

Status : Active

Type : II

Granules India

07

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35519

Submission : 2020-12-29

Status : Active

Type : II

Metrochem

08

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : Complete

Rev. Date : 2014-07-07

Pay. Date : 2014-04-21

DMF Number : 28127

Submission : 2014-03-31

Status : Active

Type : II

Dr Reddy Company Banner

09

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : Complete

Rev. Date : 2013-11-18

Pay. Date : 2013-01-16

DMF Number : 25858

Submission : 2012-03-30

Status : Active

Type : II

Dr Reddy Company Banner

10

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