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

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01 1Olpha

02 1Cohance Lifesciences

03 1Dr. Reddy\'s Laboratories

04 1Megafine Pharma (P) Limited

05 1Alembic Pharmaceuticals Limited

06 1Amsa Spa

07 1Apotex Pharmachem

08 1Emcure Pharmaceuticals

09 1Esteve Quimica

10 2Hainan Poly Pharm

11 1Hetero Drugs

12 1Hikal

13 1Industriale Chimica

14 1Lupin Ltd

15 1MSN Laboratories

16 2Macleods Pharmaceuticals Limited

17 1Olon S.p.A

18 1Orchid Pharma

19 1Procos

20 1RANBAXY LABORATORIES LIMITED

21 1Sharon Bio-Medicine Limited

22 1Sun Pharmaceutical Industries Limited

23 1Tai Heng Industry Co., Ltd

24 1Teva API

25 1Teva Pharmaceutical Industries

26 1UQUIFA

27 1Unichem Laboratories Limited

28 1Viatris

29 1Zhejiang Supor Pharmaceuticals Co., LTD

30 2Zydus Lifesciences

31 1Blank

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOlpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.

GDUFA

DMF Review : Complete

Rev. Date : 2013-02-07

Pay. Date : 2012-11-27

DMF Number : 20543

Submission : 2007-05-09

Status : Active

Type : II

Olpha

02

  • 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 : Complete

Rev. Date : 2019-04-22

Pay. Date : 2019-02-11

DMF Number : 29180

Submission : 2015-03-16

Status : Active

Type : II

Cohance

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 : 2015-11-13

Pay. Date : 2015-11-05

DMF Number : 20841

Submission : 2007-09-07

Status : Active

Type : II

Dr Reddy Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

GDUFA

DMF Review : Complete

Rev. Date : 2013-08-22

Pay. Date : 2013-04-15

DMF Number : 25402

Submission : 2011-10-14

Status : Active

Type : II

Megafine Pharma

05

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Not Confirmed

06

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06

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Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2013-11-21

Pay. Date : 2013-04-23

DMF Number : 19465

Submission : 2006-05-22

Status : Active

Type : II

blank

07

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Not Confirmed

08

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