Granules India Limited announced that its wholly owned subsidiary, Granules Life Sciences Private Limited (GLS), based in Hyderabad (FEI: 3030495702), has received approval from the U.S. Food and Drug Administration (FDA) for a finished dosage product. The approval follows a Pre-Approval Inspection (PAI) conducted from July 28 to August 1, 2025.
During the inspection, the FDA issued one observation, to which GLS responded within the stipulated timeframe. After reviewing the response, the FDA deemed the GLS facility approved and compliant, marking a significant achievement for Granules India.
A Major Milestone for Granules India
As per the press release, this is the first U.S. FDA approval for the GLS Hyderabad site, highlighting Granules India’s ongoing commitment to expanding its finished dosage manufacturing capabilities. The approval strengthens the company’s global manufacturing footprint and reinforces its dedication to maintaining high-quality standards across facilities.
Strengthening Market Presence and Business Continuity
Granules India plans to launch the approved product in the U.S. market soon. The same product is already approved and manufactured at the company’s Gagillapur facility. With this new approval, Granules aims to enhance market share and ensure business continuity through multi-site manufacturing, allowing greater flexibility and reliability in supply.
Leadership Commentary
Commenting on the milestone, Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India Limited, said,
“We plan on launching the product into the U.S. market soon. It is an already approved product at our Gagillapur facility, but we aim to build greater market share with this approval. We also have other products filed from this site and expect the U.S. FDA to approve them following the necessary audits. This marks the first approval from our second Hyderabad facility with finished dosage capabilities.”
Expanding Global Capabilities
This milestone underscores Granules India’s strategic vision of expanding its manufacturing network and enhancing global regulatory compliance. With multiple FDA-approved facilities, the company continues to strengthen its position as a trusted global pharmaceutical manufacturer delivering high-quality, affordable medicines worldwide.