Sun Pharma’s Halol site remains under an FDA import alert after eight CGMP observations; compliance efforts continue for approval.

• FDA inspection in June 2025 resulted in eight CGMP observations, keeping the Halol facility under import alert restrictions.
• Sun Pharma confirmed certain drug shortage products are exempted, but other US shipments remain blocked until compliance is achieved.
• The company pledged to work with the FDA, addressing all issues quickly to restore full CGMP compliance and lift the import alert.