Granules India’s wholly owned subsidiary -- Granules Life Sciences (GLS) has received U.S. Food and Drug Administration (USFDA) approval for a product that was the subject of a Pre-Approval Inspection (PAI) conducted between July 28 and August 1, 2025.
There was one observation during that inspection, and the GLS had submitted its response within the stipulated time. With this approval, the GLS Hyderabad facility is now deemed approved by the U.S. FDA, marking a major milestone for Granules India as it expands its finished dosage manufacturing capabilities. This is the first USFDA approval for the GLS site. The company plans to launch the approved product in the U.S. market soon. The same product is already approved and manufactured at Granules’ Gagillapur facility. The new approval will help strengthen market share and support business continuity through multi-site manufacturing.
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
