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

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$ API Ref.Price (USD/KG) : 3,015Xls
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01 2Hubei Gedian Humanwell Pharmaceutical

02 1Dr. Reddy's Laboratories

03 1Aurobindo Pharma Limited

04 2Cipla

05 1Gedeon Richter

06 1Hetero Drugs

07 1MSN Laboratories

08 1Sterling Spa

09 1Sun Pharmaceutical Industries Limited

10 1YUAN XINYAN

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : Complete

Rev. Date : 2022-09-27

Pay. Date : 2022-08-04

DMF Number : 25056

Submission : 2011-06-17

Status : Active

Type : II

Hubei Gedian Humanwell Pharmaceutical

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16010

Submission : 2002-06-11

Status : Active

Type : II

Dr Reddy Company Banner

03

  • 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 : 29764

Submission : 2015-09-20

Status : Active

Type : II

Hubei Gedian Humanwell Pharmaceutical

05

AAPS 2024
Not Confirmed

07

AAPS 2024
Not Confirmed

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