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
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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