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

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$ API Ref.Price (USD/KG) : 1,536Xls
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01 2Symbiotec Pharmalab

02 1EUROAPI

03 1Aspen API

04 1Hubei Gedian Humanwell Pharmaceutical

05 1Aurisco Pharmaceutical

06 2Bayer AG

07 1DMFs Not Supported

08 3Fujifilm Diosynth Biotechnologies

09 2Henan Lihua Pharmaceutical

10 1Hunan Yuxin Pharmaceutical Co., Ltd.

11 1Laboratorio Syntex S.A

12 1Medimpex

13 1Merck & Co

14 1Pfizer Inc

15 1Tianjin Pharmaceutical Holdings Ltd

16 1Tianjin Tianyao Pharmaceuticals Co., Ltd.

17 1Zhejiang Xianju Pharmaceutical Co. Ltd

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 24630

Submission : 2011-02-11

Status : Active

Type : II

Symbiotec Pharmalab

02

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : Complete

Rev. Date : 2013-01-28

Pay. Date : 2013-01-03

DMF Number : 3535

Submission : 1979-06-04

Status : Active

Type : II

EUROAPI Compnay Banner

03

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 27423

Submission : 2013-08-26

Status : Active

Type : II

Hubei Gedian Humanwell Pharmaceutical

05

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : Complete

Rev. Date : 2021-05-06

Pay. Date : 2021-04-09

DMF Number : 34505

Submission : 2020-02-21

Status : Active

Type : II

Symbiotec Pharmalab