TIANISH LABORATORIES PRIVATE LTD

Overview

TIANISH LABORATORIES PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 38 active FDA Type II Drug Master Files, covering APIXABAN USP; AVATROMBOPAG MALEATE; AVATROMBOPAG MALEATE [ROUTE CODE AAV]; AZATHIOPRINE USP; BEMPEDOIC ACID; BETAHISTINE HYDROCHLORIDE USP.

API / Drug Master Files

TIANISH LABORATORIES PRIVATE LTD holds 38 active (40 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.

• ELAFIBRANORActive2026-03-30
• REBAMIPIDEActive2026-03-30
• SUVOREXANTActive2026-03-29
• APIXABAN USPActive2026-03-29
• DARIDOREXANT HYDROCHLORIDEActive2026-03-28
• AVATROMBOPAG MALEATE [ROUTE CODE AAV]Active2026-03-27
• RABEPRAZOLE SODIUM USPActive2026-03-27
• RESMETIROM [ROUTE CODE ART]Active2025-12-31
• XANOMELINE TARTRATEActive2025-11-29
• RESMETIROMActive2025-10-04
• BETAHISTINE HYDROCHLORIDE USPActive2025-03-29
• LERCANIDIPINE HYDROCHLORIDE [ROUTE CODE ALPA]Active2025-03-28
• GEPIRONE HYDROCHLORIDEActive2025-03-25
• ESCITALOPRAM OXALATE USPActive2025-03-20
• MAVACAMTENActive2025-03-20

Showing 15 of 40 Drug Master Files.

FDA compliance signals

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