Granules India on Friday informed stock exchanges that its wholly owned subsidiary, Granules Life Sciences, has successfully completed a Good Manufacturing Practices (GMP) and Prior Approval Inspection conducted by the U.S. Food and Drug Administration (USFDA).
In a regulatory filing dated December 19, 2025, the company said the inspection at Granules Life Sciences’ Hyderabad facility was carried out between December 15 and December 19, 2025. The inspection concluded with five observations, all of which are related to procedural requirements.
The company clarified that none of the observations are linked to data integrity issues or product safety concerns. Granules India stated that it is committed to addressing the observations promptly and will submit its response to the USFDA within the stipulated timeframe.
Granules Life Sciences Private Limited is engaged in the manufacturing of pharmaceutical formulation intermediates (PFI) and finished dosage forms. The facility inspected by the USFDA is located in Hyderabad and operates under the establishment identifier (FEI) number 3030495702.
The disclosure was made under Regulation 30 of the SEBI Listing Obligations and Disclosure Requirements Regulations, 2015.
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