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

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$ API Ref.Price (USD/KG) : 5,814Xls
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01 1Polpharma

02 1Dr. Reddy\'s Laboratories

03 1Minakem (formerly Delmar Chemicals)

04 1Metrochem API Private Limited

05 1Cohance Lifesciences

06 1Aarti Pharmalabs

07 1Medichem S.A

08 2Neuland Laboratories

09 1ALP Pharm

10 1Actavis Inc

11 1Alembic Pharmaceuticals Limited

12 1Amoli Organics

13 1Apotex Pharmachem

14 1Aurobindo Pharma Limited

15 1Biocon

16 1Changzhou Pharmaceutical Factory

17 1Glenmark Life Sciences

18 1HEC Pharm

19 1HONOUR LAB LTD

20 1Hikal

21 1Indoco Remedies Limited

22 1Jiangxi Synergy Pharmaceutical

23 1Jubilant Generics

24 1Lee Pharma

25 2MSN Laboratories

26 1Macleods Pharmaceuticals Limited

27 1Micro Labs Limited

28 3Morepen Laboratories

29 1Natco Pharma

30 1Ningbo Menovo Pharmaceutical

31 1Optimus Pharma

32 1SINTENOVO, S.A. DE C.V.

33 1SMS Pharmaceuticals

34 2ScinoPharm Taiwan, Ltd

35 1Sichuan Qingmu Pharmaceutical

36 1Sigmapharm Laboratories, LLC

37 2Srini Pharmaceuticals

38 1Sun Pharmaceutical Industries Limited

39 1Teva API

40 1Unichem Laboratories Limited

41 1Viatris

42 1Viyash Life Sciences

43 1Zhejiang Hisun Pharmaceutical

44 1Zhejiang Huahai Pharmaceutical

45 1Zhejiang Supor Pharmaceuticals Co., LTD

46 1Zhejiang Tianyu Pharmaceutical Co., Ltd

47 1Zydus Lifesciences

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PharmaCompass

01

  • 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 : Complete

Rev. Date : 2017-02-10

Pay. Date : 2016-12-20

DMF Number : 31166

Submission : 2016-11-16

Status : Active

Type : II

Polpharma CB

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 : 2016-03-11

Pay. Date : 2015-09-30

DMF Number : 29707

Submission : 2015-09-22

Status : Active

Type : II

Dr Reddy Company Banner

03

Discovery on Target
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

GDUFA

DMF Review : Complete

Rev. Date : 2016-08-15

Pay. Date : 2016-03-28

DMF Number : 30336

Submission : 2016-03-14

Status : Active

Type : II

Minakem Delmar

04

  • 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 : 35518

Submission : 2020-12-30

Status : Active

Type : II

Metrochem

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 34988

Submission : 2020-07-02

Status : Active

Type : II

Cohance

06

  • 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 : 35969

Submission : 2021-07-01

Status : Active

Type : II

Aarti Industries Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

GDUFA

DMF Review : Complete

Rev. Date : 2016-09-20

Pay. Date : 2016-06-30

DMF Number : 30646

Submission : 2016-06-30

Status : Active

Type : II

Medichem

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : Complete

Rev. Date : 2018-07-16

Pay. Date : 2018-06-13

DMF Number : 32422

Submission : 2018-01-31

Status : Active

Type : II

Neuland

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39444

Submission : 2024-01-31

Status : Active

Type : II

Neuland