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

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$ API Ref.Price (USD/KG) : 5,895Xls
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01 1Polpharma

02 1Aarti Pharmalabs

03 1Dr. Reddy's Laboratories

04 1Actavis Inc

05 1Aurisco Pharmaceutical

06 1Catalent Pharma Solutions

07 1Cdymax

08 1Cipla

09 1Glenmark Life Sciences

10 1Hetero Drugs

11 1Laurus Labs

12 1MSN Laboratories

13 1Qingfeng Pharmaceutical Group

14 1Sai Life Sciences Limited

15 2ScinoPharm Taiwan, Ltd

16 1Shandong Anhong Pharmaceutical

17 1Shilpa Medicare

18 1Sun Pharmaceutical Industries Limited

19 1Synthon Pharmaceuticals

20 1Viatris

21 1Zhejiang Jingsheng Pharmaceutical

22 2Zydus Lifesciences

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PharmaCompass

01

AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39560

Submission : 2024-04-04

Status : Active

Type : II

Polpharma CB

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35618

Submission : 2021-04-28

Status : Active

Type : II

Aarti Industries 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 : Complete

Rev. Date : 2015-06-11

Pay. Date : 2014-12-30

DMF Number : 29117

Submission : 2015-03-31

Status : Active

Type : II

Dr Reddy Company Banner

10

AAPS 2024
Not Confirmed