Drug Master Files
West maintains an extensive portfolio of Drug Master Files (DMFs) with both the FDA and Health Canada, some of which are acknowledged to be the most heavily accessed DMFs at either agency. Upon request, West can provide Letters of Authorization/Access (LOAs) to customers for inclusion in their drug applications. Each year, West provides over 1500 LOAs to its DMFs, using a convenient online request system, Customer Connection. West Regulatory Affairs has recently worked with both FDA and Health Canada to define industry standards for conversion of packaging and process DMFs to electronic format (eCTD). We’re in the process of transitioning our portfolio to eCTD in advance of agency expectations for the industry.
Our portfolio of DMFs includes the following West products and processes.
- Contract laboratory test methods
- Daikyo Crystal Zenith® vials
- Daikyo Crystal Zenith® cartridge
- Daikyo Crystal Zenith® syringe system
- Elastomer formulations, films and coatings
- NovaPure® System
- Steam sterilization process
- Westar® RS Wash process
- Westar® RS washed Lined Seals
- Westar® RU Steam Sterilization process
- Westar® RU Gamma Sterilization Process