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

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$ API Ref.Price (USD/KG) : 1,134Xls
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01 1Minakem (formerly Delmar Chemicals)

02 1Dr. Reddy\'s Laboratories

03 1Apotex Pharmachem

04 1Aurobindo Pharma Limited

05 1China Gateway Pharmaceutical Co Ltd

06 1Cipla

07 1Formosa Laboratories

08 1Hetero Drugs

09 1LG Life Sciences

10 1Laurus Labs

11 1Linhai Huanan Chemicals Co., Ltd.

12 1Lunan Pharmaceutical

13 3MSN Laboratories

14 1Macleods Pharmaceuticals Limited

15 1Melody Healthcare Pvt Ltd

16 1Morepen Laboratories

17 1SINTENOVO, S.A. DE C.V.

18 1Sun Pharmaceutical Industries Limited

19 2Teva API

20 1Torrent Pharmaceuticals Limited

21 1Unichem Laboratories Limited

22 5Unimark Remedies Limited

23 1Viatris

24 1Zenfold Sustainable Technologies

25 2Zhejiang Tianyu Pharmaceutical Co., Ltd

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PharmaCompass

01

Discovery on Target
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 : 16243

Submission : 2002-11-15

Status : Active

Type : II

Minakem Delmar

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 : 2015-02-18

Pay. Date : 2012-12-31

DMF Number : 24516

Submission : 2010-12-31

Status : Active

Type : II

Dr Reddy Company Banner

05

Discovery on Target
Not Confirmed

10

Discovery on Target
Not Confirmed