Granules India Limited has achieved a key milestone with its wholly owned subsidiary, Granules Life Sciences Private Limited (GLS), receiving U.S. Food and Drug Administration (FDA) approval for a product inspected during a Pre-Approval Inspection (PAI) held between July 28 and August 1, 2025.
The inspection concluded with only one observation, to which GLS responded within the stipulated time frame. With this approval, the Hyderabad-based GLS facility (FEI: 3030495702) is now officially recognized by the U.S. FDA — marking its first-ever FDA approval and a major step forward in Granules India’s expansion of finished dosage manufacturing capabilities.
According to the company, the approved product is already manufactured and marketed from Granules India’s Gagillapur facility, and this new approval will enable multi-site manufacturing, ensuring business continuity and strengthening its U.S. market presence.
“We plan on launching the product into the U.S. market soon. It is an already approved product at our Gagillapur facility, but we plan on building market share with this approval,” said Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India Limited. “We also have other products filed from this site and expect the U.S. FDA to approve them following necessary audits if required. This marks the first approval from our second Hyderabad facility with finished dosage capabilities.”
This FDA nod underscores Granules India’s strong regulatory track record and its commitment to global quality standards. It also enhances the company’s capacity to meet growing demand in the U.S. pharmaceutical market, one of its key revenue drivers.
