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

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$ API Ref.Price (USD/KG) : 635Xls
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01 1Centrient Pharmaceuticals

02 1Minakem (formerly Delmar Chemicals)

03 2Amoli Organics

04 1Apotex Pharmachem

05 1Aurobindo Pharma Limited

06 2Biocon

07 1CTX Lifesciences

08 3Changzhou Pharmaceutical Factory

09 2Chromo Laboratories

10 2Glenmark Life Sciences

11 1HEC Pharm

12 1Hetero Drugs

13 1Innovare Labs

14 1Jiangsu Alpha Pharmaceutical Co., Ltd.

15 1Jubilant Generics

16 1KOLON Life Science, Inc

17 1Lee Pharma

18 3Lek Pharmaceuticals

19 1Lewens Labs

20 1Lupin Ltd

21 3MSN Laboratories

22 1Macleods Pharmaceuticals Limited

23 1Mankind Pharma

24 1Melody Healthcare Pvt Ltd

25 2Morepen Laboratories

26 1Nenter & Co., Inc.

27 2Ningbo Menovo Pharmaceutical

28 1Shanghai Desano Bio-Pharmaceutical

29 1Shanghai Wonder Pharmaceutical

30 1Sun Pharmaceutical Industries Limited

31 3Teva API

32 1Viatris

33 1ZHEJIANG HONGYUAN PHARMACEUTICAL CO. - LTD

34 1Zhejiang Hisun Pharmaceutical

35 3Zhejiang Neo-Dankong Pharm. Co.,Ltd.

36 1Zhejiang Yongtai Technology

37 1Zydus Lifesciences

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCentrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

GDUFA

DMF Review : Complete

Rev. Date : 2017-11-17

Pay. Date : 2017-05-23

DMF Number : 31410

Submission : 2017-03-28

Status : Active

Type : II

Centrient Pharmaceuticals

02

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

Virtual BoothMinakem is manufacturing small molecules APIs including corticosteroids

GDUFA

DMF Review : Complete

Rev. Date : 2016-04-08

Pay. Date : 2015-09-25

DMF Number : 29190

Submission : 2015-12-03

Status : Active

Type : II

Minakem Delmar