Granules India today announced that its wholly owned subsidiary, Granules Life Sciences(GLS), located in Hyderabad (FEI: 3030495702), has received U.S. Food and Drug Administration (FDA) approval for a product that was the subject of a Pre Approval Inspection (PAI) conducted between 28 July and 01 August 2025.
There was one observation during that inspection, and the GLS had submitted its response within the stipulated time.
With this approval, the GLS facility is now deemed approved by the U.S. FDA, marking a major milestone for Granules India as it expands its finished dosage manufacturing capabilities. This is the first FDA approval for the GLS site.
The company plans to launch the approved product in the U.S. market soon. The same product is already approved and manufactured at Granules' Gagillapur facility. The new approval will help strengthen market share and support business continuity through multi-site manufacturing.
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