Granules Life Sciences Secures First U.S. FDA Approval for Hyderabad Facility
Mumbai: Granules India Limited has announced a significant regulatory milestone with its wholly owned subsidiary, Granules Life Sciences Private Limited (GLS), receiving its first-ever U.S. Food and Drug Administration (FDA) approval. The Hyderabad-based facility (FEI: 3030495702) underwent a Pre-Approval Inspection (PAI) from July 28 to August 1, 2025, resulting in one observation, which was promptly addressed within the stipulated timeframe.
With this approval, the GLS site is now officially recognized by the U.S. FDA, marking a key step in Granules India’s expansion of its finished dosage manufacturing capabilities. The company plans to launch the approved product in the U.S. market shortly. The same product is already manufactured at Granules’ Gagillapur facility, and the new site approval will enhance market share and ensure business continuity through multi-site production.
“This approval strengthens our U.S. market presence and supports our multi-site manufacturing strategy,” said Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India Limited. “We have additional products filed from this facility and expect further approvals following requisite audits. This marks the first FDA nod for our second Hyderabad site with finished dosage capabilities.”
The approval reinforces Granules India’s commitment to global quality standards and its strategic focus on regulatory compliance and manufacturing excellence.
