Granules Life Sciences, a subsidiary of Granules India, has completed an FDA inspection at its Hyderabad facility (FEI: 3030495702). The inspection, conducted from December 15th to 19th, 2025, concluded with five observations related to procedural requirements. The company is committed to addressing the observations and will submit its response to the USFDA within the stipulated timeframe. No data integrity or product safety concerns were raised.
FDA Inspection Update
Granules Life Sciences Private Limited (GLS), a wholly-owned subsidiary of Granules India, has successfully completed a Good Manufacturing Practices (GMP) and Prior Approval Inspection by the U.S. Food and Drug Administration (FDA) at its Hyderabad facility.
Inspection Details and Findings
The inspection, conducted between December 15th and 19th, 2025, resulted in five observations pertaining to procedural matters. Importantly, none of the observations raised concerns regarding data integrity or product safety.
Company Response and Commitment
Granules India has stated its commitment to promptly addressing the observations and submitting a comprehensive response to the USFDA within the designated timeframe. The company is dedicated to maintaining compliance with all regulatory standards.
About Granules Life Sciences
Granules Life Sciences Private Limited is focused on the manufacturing of PFI (Pharmaceutical Formulation Intermediates) and Finished Dosages. The conclusion of this inspection signifies the company’s dedication to quality and compliance in its manufacturing processes.
Source: BSE