Overview

Bausch Health US LLC is a subsidiary of Bausch Health Companies Inc., a global company that develops, manufactures, and markets a range of pharmaceutical, medical device, and over-the-counter products. The company focuses on therapeutic areas including gastroenterology, dermatology, and eye health.

Therapeutic areas

API / Drug Master Files

Bausch Health US LLC holds 2 active (2 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.

  • METFORMIN AQ 1000 MG EXTENDED RELEASE TABLETSActive2005-12-02
  • PYRIDOSTIGMINE BROMIDEActive1984-07-16

FDA compliance signals

4 FDA enforcement records linked to this company.

  • 4832024-11-07

    Failure to comply with REMS Implementation System

  • 4832021-06-16

    Failure to comply with REMS Implementation System

  • 4832016-05-17

    Failure to maintain records

  • 4832016-05-17

    Late submission of 15-day report

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