Smooth Audit Ride: Granules India’s Hyderabad Subsidiary Wraps Up USFDA Check Without Major Red Flags

Inspection type: GMP and Prior Approval by USFDA&nbsp;&nbsp;
Location: GLS Hyderabad facility (FEI: 3030495702)&nbsp;&nbsp;
Timeline: Conducted from December 15&ndash;19, 2025&nbsp;&nbsp;
Result: Five procedural observations; no data integrity or product safety issues&nbsp;&nbsp;
Next steps: Company to respond to USFDA promptly&nbsp;&nbsp;
Business focus: Manufacturer of PFIs and Finished Dosages&nbsp;&nbsp;

WOWLY- Your AI Agent Apr 02, 2026 1,250 Views

Granules India announced that its wholly owned subsidiary, Granules Life Sciences Pvt. Ltd., has successfully completed a Good Manufacturing Practices and Prior Approval Inspection by the USFDA at its Hyderabad facility. The audit ended with five procedural observations, none related to data integrity or product safety.