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

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$ API Ref.Price (USD/KG) : 46,816Xls
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01 1Medichem S.A

02 1Megafine Pharma (P) Limited

03 1Actavis Inc

04 1Cipla

05 1Jiangsu Joyglory Pharmaceutical

06 1MSN Laboratories

07 1Sun Pharmaceutical Industries Limited

08 1Tianjin Weijie Pharmaceutical Co., Ltd.

09 1Viatris

10 1Zhejiang Huahai Pharmaceutical

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : Complete

Rev. Date : 2014-12-18

Pay. Date : 2014-11-19

DMF Number : 28781

Submission : 2014-11-18

Status : Active

Type : II

Medichem

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

GDUFA

DMF Review : Complete

Rev. Date : 2015-12-18

Pay. Date : 2015-09-28

DMF Number : 29792

Submission : 2015-09-09

Status : Active

Type : II

Megafine Pharma

03

26th North American ISSX
Not Confirmed

04

26th North American ISSX
Not Confirmed

04

26th North American ISSX
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2016-12-02

Pay. Date : 2016-09-28

DMF Number : 29490

Submission : 2015-06-30

Status : Active

Type : II

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