AMI LIFESCIENCES PRIVATE LTD

Overview

AMI LIFESCIENCES PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 44 active FDA Type II Drug Master Files, covering AVATROMBOPAG MALEATE; BEMPEDOIC ACID; BENZONATATE; BRIVARACETAM; BRIVARACETAM (PROCESS-II); DAPAGLIFLOZIN AMORPHOUS.

API / Drug Master Files

AMI LIFESCIENCES PRIVATE LTD holds 44 active (44 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.

• DESVENLAFAXINEActive2026-03-31
• FEZOLINETANTActive2026-03-27
• RESMETIROMActive2026-02-27
• FLUVOXAMINE MALEATEActive2026-01-30
• AVATROMBOPAG MALEATEActive2026-01-06
• OLAPARIBActive2025-09-27
• VADADUSTATActive2025-09-25
• BRIVARACETAM (PROCESS-II)Active2025-05-30
• HYDRALAZINE HYDROCHLORIDEActive2025-03-27
• FINERENONE (PROCESS-II)Active2025-02-25
• MIROGABALIN BESYLATE (PROCESS-II)Active2025-02-12
• TOLVAPTANActive2024-12-04
• MIRABEGRONActive2024-10-24
• TEGOPRAZAN (CRYSTALLINE)Active2024-10-07
• ENZALUTAMIDEActive2024-09-23

Showing 15 of 44 Drug Master Files.

FDA compliance signals

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