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

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01 2EUROAPI

02 1Pfizer CentreOne

03 1Axplora

04 1Sanofi

05 2Symbiotec Pharmalab

06 1Bayer AG

07 3Curia

08 2Fujifilm Diosynth Biotechnologies

09 3Henan Lihua Pharmaceutical

10 1Hikma Pharmaceuticals

11 1Jiangsu Lianhuan Pharmaceutical

12 1Reliable Biopharmaceutical Corporation

13 2Shandong Xinhua Pharmaceutical

14 1Shanghai New Hualian Pharmaceutical

15 2Tianjin Jinjin Pharmaceutical Co Ltd

16 1Tianjin Pharmaceutical Holdings Ltd

17 1Tianjin Tianyao Pharmaceuticals Co., Ltd.

18 2Yangzhou Pharmaceutical

19 1Zhejiang Xianju Pharmaceutical Co. Ltd

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 2789

Submission : 1976-11-11

Status : Active

Type : II

EUROAPI Compnay Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2013-02-26

Pay. Date : 2013-02-13

DMF Number : 1413

Submission : 1969-09-02

Status : Active

Type : II

Pfizer centreOne

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAxplora- The partner of choice for complex APIs.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37639

Submission : 2023-01-24

Status : Active

Type : II

Axplora CB

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7416

Submission : 1988-04-04

Status : Inactive

Type : II

Sanofi Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2016-02-09

Pay. Date : 2015-06-09

DMF Number : 29221

Submission : 2015-03-30

Status : Active

Type : II

Symbiotec Pharmalab

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

GDUFA

DMF Review : Complete

Rev. Date : 2016-08-04

Pay. Date : 2016-04-08

DMF Number : 30373

Submission : 2016-03-03

Status : Active

Type : II

EUROAPI Compnay Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2019-12-27

Pay. Date : 2019-12-03

DMF Number : 31349

Submission : 2017-01-12

Status : Active

Type : II

Symbiotec Pharmalab

08

Pharmaconex 2024
Not Confirmed

10

Pharmaconex 2024
Not Confirmed

10

Pharmaconex 2024
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2015-07-02

Pay. Date : 2014-12-16

DMF Number : 19734

Submission : 2006-09-06

Status : Active

Type : II

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