Customers frequently cite West’s Drug Master Files (DMF) in their filings with the U.S. Food and Drug Administration and Health Canada.
West’s DMFs filed with the FDA and Health Canada include:
- Westar® RS washing process – FDA Type V and Health Canada Type II (each Westar plant – Eschweiler, Germany; Jersey Shore, Pa.; LeNouvion, France; and Singapore – has its own DMF)
- Elastomer formulations and coatings – FDA Type III, Health Canada Type II (globally applicable)
- Laboratory Services Test Methods – FDA Type II, Health Canada Type III
Westar® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.