Overview

KALINTIS HEALTHCARE PVT LTD is an active pharmaceutical ingredient (API) supplier with 12 active FDA Type II Drug Master Files, covering BENZTROPINE MESYLATE USP; CEVIMELINE HYDROCHLORIDE USP; DIPHENOXYLATE HYDROCHLORIDE; DIPHENOXYLATE HYDROCHLORIDE USP + ATROPINE SULPHATE USP MIXTURE; FUROSEMIDE USP; LORAZEPAM USP.

Core services & business areas

API Manufacturing

Active pharmaceutical ingredients supplied

Substances KALINTIS HEALTHCARE PVT LTD 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.

API / Drug Master Files

KALINTIS HEALTHCARE PVT LTD holds 10 active (10 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.

  • KETOTIFEN FUMARATEActive2026-06-10
  • METHYLENE BLUEActive2026-04-06
  • METHENAMINE HIPPURATE USPActive2025-12-06
  • METHIMAZOLE USPActive2024-12-02
  • CEVIMELINE HYDROCHLORIDE USPActive2023-09-25
  • OXAZEPAM USPActive2022-12-10
  • LORAZEPAM USPActive2020-12-11
  • MEXILETINE HYDROCHLORIDE USPActive2020-09-23
  • BENZTROPINE MESYLATE USPActive2020-07-29
  • FUROSEMIDE USPActive2018-08-06

FDA compliance signals

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

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