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

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$ API Ref.Price (USD/KG) : 295Xls
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01 1EUROAPI

02 1Nortec Quimica

03 1ACS DOBFAR SPA

04 1Bayer AG

05 1Dasami Lab

06 1Fujifilm Diosynth Biotechnologies

07 1Gedeon Richter

08 1Medimpex

09 1Olon S.p.A

10 1Piramal Pharma Solutions

11 1Roche Diagnostics GmbH

12 1Tianjin Jinjin Pharmaceutical Co Ltd

13 1Tianjin Tianyao Pharmaceuticals Co., Ltd.

14 1Yicheng Goto Pharmaceuticals Co Ltd

15 1ZHEJIANG LANGHUA PHARMACEUTICAL CO., LTD.

16 1Zhejiang Shenzhou Pharmaceutical

17 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 : Complete

Rev. Date : 2013-02-06

Pay. Date : 2013-01-23

DMF Number : 17264

Submission : 2004-03-26

Status : Active

Type : II

EUROAPI Compnay Banner

02

34th IFSCC
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNortec Quimica is the largest API manufacturer in Latin America.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37708

Submission : 2024-06-06

Status : Active

Type : II

Nortec Quimica

04

34th IFSCC
Not Confirmed

04

34th IFSCC
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2022-05-09

Pay. Date : 2022-01-31

DMF Number : 36678

Submission : 2022-02-04

Status : Active

Type : II

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06

34th IFSCC
Not Confirmed

09

34th IFSCC
Not Confirmed

09

10

34th IFSCC
Not Confirmed

10