Granules India’s subsidiary, Granules Life Sciences Private Limited (GLS) in Hyderabad, has received its first U.S. Food and Drug Administration (FDA) approval. The approval follows a Pre-Approval Inspection (PAI) conducted between July 28 and August 1, 2025. The company plans to soon launch the approved product in the U.S. market, complementing existing production at its Gagillapur facility. This marks a significant milestone for expanding manufacturing capabilities.
Hyderabad Facility Gains Approval
Granules India Limited announced that its wholly owned subsidiary, Granules Life Sciences Private Limited (GLS), has received U.S. FDA approval for a product following a successful Pre-Approval Inspection (PAI) conducted between July 28th and August 1st, 2025.
Inspection Details
During the inspection, there was one observation, to which GLS promptly submitted its response within the stipulated timeframe.
Significance of the Approval
The FDA approval signifies a major achievement for Granules India, enhancing its finished dosage manufacturing capabilities. This marks the first FDA approval for the GLS site.
Launch Plans
The company plans to launch the approved product in the U.S. market shortly. This product is already manufactured at Granules’ Gagillapur facility. This approval will help increase market share and support business continuity across multiple manufacturing locations.
Executive Commentary
Dr. Krishna Prasad Chigurupati, Chairman & Managing Director of Granules India Limited, commented, “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. 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.”
Source: BSE
