Facility Profile: The facility manufactures generic and authorized generic injectable product for the U.S. market including injectables, intravenous solutions, liposomal injectables, and specialty sterile formulations.
• Products Likely Exposed to Shortages (Based on Market Share >20%, Sales >$3Mn & No Backup Manufacturing): No products identified under shortage-risk criteria.
• Revenue Contribution: The facility contributes significant % of total estimated U.S. sales (excluding Biosimilar Sales). Authorized generic is already genericized with multiple competitors, resulting in limited market exclusivity.
• Backup Coverage: Few of the products from this facility are supported through alternate manufacturing sites.
• Financial Impact: Prolonged remediation timelines could increase compliance costs and impact injectable product supply without backup facility.
• Inspection History: The facility maintained a VAI compliance history across the last three U.S. FDA inspections (Mar 2020, Feb 2023, and Apr 2024).