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).

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

No FDA recalls, Warning Letters, or Form 483 observations are linked to MEGAFINE PHARMA P LTD in our records. PharmaTek screens the full directory against live FDA enforcement data.