NAVINTA LLC

United States navinta.com

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.

Core services & business areas

API ManufacturingPharmaceutical Manufacturing

Active pharmaceutical ingredients supplied

Substances NAVINTA LLC is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

HydralazineSevelamer CarbonateCyclophosphamideIron SucroseSodium NitroprussideSevelamer HydrochlorideBendamustineFosaprepitant DimeglumineTafamidis MeglumineRopivacaineColesevelam HydrochlorideNicardipineTrientinePenicillamineMelphalan HydrochlorideRilpivirine HydrochlorideGlycerol PhenylbutyratePhytonadioneDiazepamBenztropineCisatracuriumPhenoxybenzamineFomepizoleTriheptanoinSodium PhenylbutyrateRemifentanil HydrochlorideMiglustatCrizotinibMaravirocDeferoxamineSodium Ferric Gluconate ComplexTaurolidine

API / Drug Master Files

NAVINTA LLC holds 37 active (39 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.

  • RILPIVIRINE HYDROCHLORIDEActive2026-04-28
  • 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

Showing 15 of 39 Drug Master Files.

FDA compliance signals

10 FDA enforcement records linked to this company.

  • 4832019-03-28

    Failure to submit scientific article

  • 4832017-08-18

    Failure to maintain records

  • 4832017-08-18

    Late submission of an ICSR

  • 4832017-08-18

    Incomplete periodic safety report

  • 4832017-08-18

    Late submission of 15-day report

  • warning_letter2016-09-26

    FDA Warning Letter (drug product)

  • 4832016-05-16

    Interval

  • 4832016-05-16

    Failure to develop written procedures

  • 4832016-05-16

    Timely submission

  • recall — Class II2015-04-15

    Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.

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