Granules Life Sciences’ Hyderabad Site Wins First USFDA Nod

’s subsidiary, Granules Life Sciences (GLS) in Hyderabad, has secured its first approval from the U.S. FDA for a product inspected during a Pre-Approval Inspection conducted between July 28 and August 1, 2025, marking a key milestone in the company’s expansion of finished dosage manufacturing capabilities in the U.S. market . The inspection resulted in a single observation, which GLS addressed within the stipulated timeframe, leading to the facility being deemed approved by the regulator . The approved product had already cleared and manufactured at Granules’ Gagillapur plant will be launched in the U.S. soon, enabling multi-site production that strengthens market share, ensures business continuity, and reduces supply risk through redundancy. Disclaimer: This post is for informational purposes only and not a recommendation to buy or sell any securities. I, or my family, associates, or relatives, may have a financial interest in the securities mentioned.