Taro Pharmaceutical Industries Ltd.

Overview

Taro Pharmaceutical Industries Ltd. is a research-based international pharmaceutical company that develops, manufactures, and markets affordable prescription and over-the-counter pharmaceutical products. It operates primarily in the U.S., Canada, and Israel, with a strong focus on dermatology, topical, and oral medications.

Therapeutic areas

API / Drug Master Files

Taro Pharmaceutical Industries Ltd. holds 80 active (160 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.

  • TAPINAROFActive2026-01-15
  • TIRBANIBULINActive2024-08-01
  • IMIQUIMOD, USP (NEW ROS)Active2024-03-31
  • TRIFAROTENEActive2023-03-31
  • IVOSIDENIBActive2022-02-04
  • NILOTINIB HYDROCHLORIDE FORM ALPHAActive2020-07-14
  • DOCOSANOLActive2019-03-18
  • UMECLIDINIUM BROMIDEActive2018-08-12
  • TICAGRELORActive2018-03-30
  • TAVABOROLEActive2018-03-26
  • LULICONAZOLEActive2017-03-30
  • TERBINAFINE HYDROCHLORIDE USPActive2017-03-23
  • PERAMPANEL 3/4 HYDRATE, MICRONIZEDActive2016-06-30
  • DAPSONE USPActive2016-03-31
  • AZELAIC ACID, MICRONIZEDActive2015-12-01

Showing 15 of 160 Drug Master Files.

FDA compliance signals

1 FDA enforcement record linked to this company.

  • 4832019-07-11

    Extent of discrepancy, failure investigations

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