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List of Drug Master Files (DMF) of MolPort-002-054-532 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 2Biophore India Pharmaceuticals Pvt Ltd

02 1Ahk Tech

03 1Axitec

04 2Cilag AG

05 1Guangzhou Henovcom Biosciences

06 1Hubei Biocause Heilen Pharmaceutical Co., Ltd

07 2MSN Laboratories

08 1Reliable Biopharmaceutical Corporation

09 1ScinoPharm Taiwan, Ltd

10 1Zhejiang Hisun Pharmaceutical

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

GDUFA

DMF Review : Complete

Rev. Date : 2021-11-09

Pay. Date : 2021-09-28

DMF Number : 36221

Submission : 2021-08-30

Status : Active

Type : II

Biophore

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36222

Submission : 2021-08-31

Status : Active

Type : II

Biophore

08

AAPS 2024
Not Confirmed

08

AAPS 2024
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2018-10-15

Pay. Date : 2018-06-27

DMF Number : 13006

Submission : 1998-05-28

Status : Active

Type : II

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