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

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01 2IOL Chemicals and Pharmaceuticals

02 1Polpharma

03 1Cohance Lifesciences

04 1Taro Pharmaceutical Industries

05 1Medichem S.A

06 1Adare Pharma Solutions

07 1Alembic Pharmaceuticals Limited

08 1Alkem Laboratories

09 1Apotex Pharmachem

10 1Aragen Life Sciences

11 1Aurobindo Pharma Limited

12 1CTX Lifesciences

13 1Cambrex Corporation

14 1Cipla

15 1Gedeon Richter

16 1Jubilant Generics

17 1Lupin Ltd

18 1SEQUEL PHARMACHEM PRIVATE LTD. IN 400 706 Nerul

19 1SMS Pharmaceuticals

20 1Sun Pharmaceutical Industries Limited

21 1Suven Life Sciences Limited

22 1Syn-Tech Chem. & Pharm

23 1Synthexim

24 1Teva API

25 1Torrent Pharmaceuticals Limited

26 1UQUIFA

27 1Unichem Laboratories Limited

28 1Unimark Remedies Limited

29 1Viatris

30 1Waterstone Pharmaceuticals Inc.

31 1Zhejiang Huahai Pharmaceutical

32 1Zhejiang Supor Pharmaceuticals Co., LTD

33 1Zydus Lifesciences

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 26627

Submission : 2012-11-15

Status : Active

Type : II

IOL Chemicals

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

GDUFA

DMF Review : Complete

Rev. Date : 2015-02-25

Pay. Date : 2014-06-11

DMF Number : 20548

Submission : 2007-05-23

Status : Active

Type : II

Polpharma CB

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

GDUFA

DMF Review : Complete

Rev. Date : 2013-08-29

Pay. Date : 2013-03-20

DMF Number : 23251

Submission : 2009-11-04

Status : Active

Type : II

Cohance

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17231

Submission : 2004-03-12

Status : Active

Type : II

Medichem

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36531

Submission : 2021-12-20

Status : Active

Type : II

IOL Chemicals

07

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Not Confirmed

08

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Not Confirmed