NAVINTA LLC

Overview

NAVINTA LLC is an active pharmaceutical ingredient (API) supplier with 36 active FDA Type II Drug Master Files, covering BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE; BENZTROPINE MESYLATE USP; CISATRACURIUM BESYLATE USP; COLESEVELAM HYDROCHLORIDE; CRIZOTINIB; CYCLOPHOSPHAMIDE USP.

API / Drug Master Files

NAVINTA LLC holds 36 active (38 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.

• CISATRACURIUM BESYLATE USPActive2025-06-18
• GLYCEROL PHENYLBUTYRATEActive2025-04-03
• SODIUM PHENYLBUTYRATE USPActive2025-02-24
• TAFAMIDIS MEGLUMINEActive2024-07-29
• TRIHEPTANOINActive2024-03-26
• CRIZOTINIBActive2024-01-08
• DIAZEPAM USPActive2023-09-27
• COLESEVELAM HYDROCHLORIDEActive2023-07-18
• CYCLOPHOSPHAMIDE USPActive2023-03-31
• MARAVIROCActive2022-03-30
• DS166 DRUG SUBSTANCEActive2022-03-25
• MIGLUSTATActive2021-11-10
• CYCLOPHOSPHAMIDE USP (STERILE)Active2021-09-28
• PENICILLAMINE USPActive2018-09-28
• DS108 DRUG SUBSTANCEActive2018-09-27

Showing 15 of 38 Drug Master Files.

FDA compliance signals

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