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

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$ API Ref.Price (USD/KG) : 6,337Xls
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01 1Biophore India Pharmaceuticals Pvt Ltd

02 1Dr. Reddy\'s Laboratories

03 1Moehs Iberica

04 1Aarti Pharmalabs

05 1Neuland Laboratories

06 1Aurisco Pharmaceutical

07 1Changzhou Pharmaceutical Factory

08 1Chengda Pharmaceuticals

09 1Formosa Laboratories

10 1Glenmark Life Sciences

11 1Hetero Drugs

12 1Lunan Pharmaceutical

13 1Lupin Ltd

14 1MSN Laboratories

15 1Optimus Pharma

16 1ScinoPharm Taiwan, Ltd

17 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.

18 1Sun Pharmaceutical Industries Limited

19 1Teva Pharmaceutical Industries

20 1Zhejiang Huahai 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 : 2022-04-15

Pay. Date : 2022-03-30

DMF Number : 36646

Submission : 2021-12-30

Status : Active

Type : II

Biophore

02

  • 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 : 2022-01-26

Pay. Date : 2021-12-17

DMF Number : 35473

Submission : 2021-01-22

Status : Active

Type : II

Dr Reddy Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38220

Submission : 2023-03-27

Status : Active

Type : II

Moehs Iberica

04

  • 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 : 36636

Submission : 2022-02-25

Status : Active

Type : II

Aarti Industries Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36947

Submission : 2022-03-31

Status : Active

Type : II

Neuland

08

Discovery on Target
Not Confirmed

09

Discovery on Target
Not Confirmed

10

Discovery on Target
Not Confirmed