MEGAFINE PHARMA P LTD

Overview

MEGAFINE PHARMA P LTD is an active pharmaceutical ingredient (API) supplier with 27 active FDA Type II Drug Master Files, covering 1-(3-HYDROXY METHYL PYRIDYL-2-)-2-PHENYL-4-METHYL PIPERAZINE (HMPPMP) (NON-STERILE DRUG SUBSTANCE INTERMEDIATE); AMBRISENTAN; APIXABAN (NON-STERILE DRUG SUBSTANCE); APREMILAST (NON-STERILE DRUG SUBSTANCE); ASENAPINE MALEATE (NON-STERILE DRUG SUBSTANCE); BOSENTAN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE).

Core services & business areas

API Manufacturing

Active pharmaceutical ingredients supplied

Substances MEGAFINE PHARMA P LTD is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

API / Drug Master Files

MEGAFINE PHARMA P LTD holds 27 active (28 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

  • DESVENLAFAXINE SUCCINATE MONOHYDRATE USP (NON-STERILE DRUG SUBSTANCE)Active2025-08-27
  • APIXABAN (NON-STERILE DRUG SUBSTANCE)Active2025-01-05
  • APREMILAST (NON-STERILE DRUG SUBSTANCE)Active2024-12-27
  • VORTIOXETINE HYDROBROMIDE (NON-STERILE DRUG SUBSTANCE)Active2024-11-27
  • EDOXABAN TOSYLATE MONOHYDRATE (NON-STERILE DRUG SUBSTANCE)Active2024-11-27
  • LURASIDONE HYDROCHLORIDEActive2024-10-08
  • TERIFLUNOMIDE DRUG SUBSTANCEActive2015-09-29
  • MIRABEGRON DRUG SUBSTANCEActive2015-09-25
  • AMBRISENTANActive2015-09-09
  • PRASUGREL HYDROCHLORIDEActive2015-08-14
  • RIVAROXABAN (NON-STERILE DRUG SUBSTANCE)Active2014-12-10
  • ASENAPINE MALEATE (NON-STERILE DRUG SUBSTANCE)Active2013-06-30
  • DARIFENACIN HYDROBROMIDE (NON STERILE DRUG SUBSTANCE)Active2012-09-30
  • PALIPERIDONE USP (NON- STERILE DRUG SUBSTANCE)Active2011-12-28
  • MEMANTINE HYDROCHLORIDE USPActive2011-10-14

Showing 15 of 28 Drug Master Files.

FDA compliance signals

2 FDA enforcement records linked to this company.

  • warning_letter2017-02-24

    FDA Warning Letter (drug product)

  • warning_letter2016-05-19

    FDA Warning Letter (drug product)

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