METROCHEM API PRIVATE LTD

Overview

METROCHEM API PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 81 active FDA Type II Drug Master Files, covering ALOGLIPTIN BENZOATE; ANTAZOLINE PHOSPHATE USP; APIXABAN; BEMPEDOIC ACID; BILASTINE; BILASTINE (BTN).

API / Drug Master Files

METROCHEM API PRIVATE LTD holds 81 active (84 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.

• BILASTINE (BTN)Active2025-12-31
• MAVACAMTENActive2025-12-30
• DEXLANSOPRAZOLE ANHYDROUS (DXM)Active2025-12-30
• RIMEGEPANT SULFATEActive2025-12-29
• MIGALASTAT HYDROCHLORIDE (MAL)Active2025-12-29
• SAXAGLIPTIN HYDROCHLORIDE DIHYDRATEActive2025-09-25
• RESMETIROMActive2025-08-08
• ETORICOXIBActive2025-06-24
• TAPINAROFActive2025-03-31
• VORTIOXETINE HYDROCHLORIDEActive2024-12-31
• VORTIOXETINE HYDROBROMIDEActive2024-12-31
• TRELAGLIPTIN SUCCINATEActive2024-11-20
• CENOBAMATEActive2024-10-28
• SILODOSIN GAMMA FORMActive2024-10-01
• NICARDIPINE HYDROCHLORIDE USPActive2024-08-31

Showing 15 of 84 Drug Master Files.

FDA compliance signals

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