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

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$ API Ref.Price (USD/KG) : 11,232Xls
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01 2Dr. Reddy\'s Laboratories

02 1Porton Pharma Solutions

03 1Alembic Pharmaceuticals Limited

04 1Aurisco Pharmaceutical

05 1Aurobindo Pharma Limited

06 1Hetero Drugs

07 1Laurus Labs

08 1MSN Laboratories

09 1Zydus Lifesciences

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

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

GDUFA

DMF Review : Complete

Rev. Date : 2020-10-28

Pay. Date : 2020-09-30

DMF Number : 34667

Submission : 2020-03-24

Status : Active

Type : II

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPorton Pharma Solutions: Value creation via innovation & discovery through technical platforms.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39029

Submission : 2023-11-02

Status : Active

Type : II

Porton Company Banner

03

  • 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 : 35740

Submission : 2021-03-25

Status : Active

Type : II

Dr Reddy Company Banner

07

FNCE 2024
Not Confirmed

08

FNCE 2024
Not Confirmed

10

FNCE 2024
Not Confirmed

Apalutamide Manufacturers | Traders | Suppliers

Apalutamide Manufacturers, Traders, Suppliers 1