The U.S. Food & Drug Administration (USFDA) has concluded Pre-Approval Inspection (PAI) at Granules India’s wholly owned Indian subsidiary -- M/s Granules Life Sciences’ Hyderabad facility. The USFDA has conducted inspection from July 28, 2025 to August 01, 2025. The said facility has received one 483 observation, which is procedural in nature.
The Company will respond to this observation within the stipulated time. Granules Life Sciences is engaged in the manufacturing of PFI & Finished Dosages.
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages.
