India, Nov. 11 -- Granules India Limited announced that its wholly owned subsidiary, Granules Life Sciences Pvt. Ltd. (GLS), has received its first U.S. Food and Drug Administration (FDA) approval for a product following a Pre-Approval Inspection (PAI) conducted from July 28 to August 1, 2025 at its Hyderabad facility.
The inspection resulted in a single observation, which the company addressed within the stipulated timeframe. With this approval, the GLS facility is now deemed U.S. FDA-approved, marking a significant milestone in expanding Granules India's finished dosage manufacturing capabilities.
The approved product, already manufactured at the company's Gagillapur facility, will soon be launched in the U.S. market. The new approval w...