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

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$ API Ref.Price (USD/KG) : 16,069Xls
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01 1Minakem (formerly Delmar Chemicals)

02 2Metrochem API Private Limited

03 1Dr. Reddy\'s Laboratories

04 1Chunghwa Chemical Synthesis & Biotech

05 1Apotex Pharmachem

06 1Aurore Life Sciences

07 1Beijing Mesochem Technology

08 1Beijing Sjar Technology Development

09 1Changzhou Pharmaceutical Factory

10 1Glenmark Life Sciences

11 1HONOUR LAB LTD

12 1Hunan Warrant Chiral Pharmaceutical

13 1Intas Pharmaceuticals

14 1Lee Pharma

15 1MSN Laboratories

16 1Macleods Pharmaceuticals Limited

17 1Micro Labs Limited

18 1Olon S.p.A

19 1PharmaBlock Sciences

20 1Qilu Tianhe Pharmaceutical Co., Ltd.

21 1SINTENOVO, S.A. DE C.V.

22 1Sun Pharmaceutical Industries Limited

23 1Unichem Laboratories Limited

24 1Viatris

25 1Yabao Pharmaceutical Group Co. Ltd

26 1Zhejiang Ausun Pharmaceutical

27 1Zhejiang Huahai Pharmaceutical

28 1Zydus Lifesciences

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PharmaCompass

01

Luxepack
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 33332

Submission : 2018-12-21

Status : Active

Type : II

Minakem Delmar

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35976

Submission : 2021-05-29

Status : Active

Type : II

Metrochem

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 : 2023-12-20

Pay. Date : 2023-11-15

DMF Number : 37164

Submission : 2022-07-29

Status : Active

Type : II

Dr Reddy Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37532

Submission : 2022-10-28

Status : Active

Type : II

CCSB Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

GDUFA

DMF Review : Complete

Rev. Date : 2024-03-06

Pay. Date : 2024-01-31

DMF Number : 38994

Submission : 2023-12-02

Status : Active

Type : II

Metrochem

10

Luxepack
Not Confirmed