West’s Competitive Edge
Unmatched experience/expertise: drug material interface
Ability to source components from multiple locations
Protected IP: West’s components and systems
Regulatory barrier to entry: NDA and ANDA filing must include reference to all packaging/components in contact with the drug:
- West Drug Master File (DMF) 1546 is confidential
- West DMF includes functionality data (multi-year studies)
- All primary package changes require new stability/ functionality studies for new filing