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

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01 1Megafine Pharma (P) Limited

02 1Pharmathen SA

03 1Amino Chemicals

04 1Apotex Pharmachem

05 1Aurobindo Pharma Limited

06 1Cadila Pharmaceuticals

07 1Cipla

08 1Emcure Pharmaceuticals

09 1Glenmark Life Sciences

10 1Johnson & Johnson Innovative Medicine

11 1Jubilant Generics

12 1Lupin Ltd

13 1MSN Laboratories

14 1Macleods Pharmaceuticals Limited

15 1Orchid Pharma

16 1Par Pharmaceutical

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

18 1Sun Pharmaceutical Industries Limited

19 1Teva API

20 1Torrent Pharmaceuticals Limited

21 1Unichem Laboratories Limited

22 1Unimark Remedies Limited

23 1Viatris

24 1Wockhardt

25 1Zhejiang Huahai Pharmaceutical

26 1Zydus Lifesciences

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PharmaCompass

01

  • 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 : 2013-10-07

Pay. Date : 2013-09-26

DMF Number : 25642

Submission : 2011-12-28

Status : Active

Type : II

Megafine Pharma

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

GDUFA

DMF Review : Complete

Rev. Date : 2017-02-27

Pay. Date : 2016-12-01

DMF Number : 31062

Submission : 2016-12-27

Status : Active

Type : II

Pharmathen

03

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05

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06

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