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List of Drug Master Files (DMF) of Ambap5429 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 68,727Xls
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01 1Fishfa Biogenics

02 1Farmhispania

03 3Chunghwa Chemical Synthesis & Biotech

04 1ACS DOBFAR SPA

05 1Apotex Fermentation Inc.

06 1Astellas Pharma

07 4Biocon

08 1CKD Bio Corporation

09 2Concord Biotech

10 1Hangzhou Huadong Medicine Group Kangrun Pharmaceutical

11 1Hangzhou Zhongmei Huadong Pharmaceutical

12 1JOYANG LABORATORIES

13 2Lek Pharmaceuticals

14 2Lunan Pharmaceutical

15 1Murli Krishna Pharma

16 1North China Pharmaceutical Huasheng Co Ltd

17 1Teva API

18 1Wuxi Fortune Pharmaceutical Co., Ltd

19 2Zhejiang Hisun Pharmaceutical

20 1Blank

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39667

Submission : 2024-03-19

Status : Active

Type : II

Fishfa Biogenics

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFarmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35852

Submission : 2021-04-23

Status : Active

Type : II

Farmhispania

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

GDUFA

DMF Review : Complete

Rev. Date : 2016-04-01

Pay. Date : 2016-03-09

DMF Number : 18985

Submission : 2005-11-28

Status : Active

Type : II

CCSB Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38310

Submission : 2023-04-26

Status : Active

Type : II

CCSB Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 23213

Submission : 2009-10-26

Status : Active

Type : II

CCSB Company Banner

09

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10

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