Overview

Bausch Health Americas, Inc. is a subsidiary of Bausch Health Companies Inc., a global company focused on improving people’s lives with its health care products. It is involved in the development, manufacture, and market of a wide range of pharmaceuticals, focusing on therapeutic areas such as eye health, gastroenterology, and dermatology.

Therapeutic areas

API / Drug Master Files

Bausch Health Americas, Inc. holds 1 active (1 total) FDA Type II Drug Master File — 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.

  • PENICILLAMINE USPActive2010-07-30

FDA compliance signals

7 FDA enforcement records linked to this company.

  • 4832024-04-12

    Procedures not in writing, fully followed

  • 4832015-07-28

    Determination not to conduct investigation of complaint

  • 4832015-07-28

    Labeling: documentation of exam and review

  • 4832015-07-28

    Investigations of discrepancies, failures

  • 4832015-07-28

    Testing of reconstituted drugs

  • 4832015-07-28

    Quarantine - actual practice

  • 4832015-07-28

    Written procedures followed

Ready to Accelerate Your
Discovery Workflow?

Find, vet, and source drug-manufacturing partners faster — with FDA compliance screening built in. Start free for 14 days.