Granules Life Sciences secures first U.S. FDA approval

Generic drugmaker Granules India subsidiary Granules Life Sciences (GLS), located in Hyderabad, has received U.S. Food and Drug Administration (U.S. FDA) approval for a product that earlier this year was the subject of a pre-approval inspection (PAI).

The GLS facility is now deemed approved by the U.S. FDA, marking a milestone as Granules India expands its finished dosage manufacturing capabilities. This is the first FDA approval for the GLS site, the parent company said on Tuesday (November 11, 2025). There was one observation from the U.S. FDA during the inspection conducted between July 28 and August 1. The company had submitted its response within the stipulated time, it said.

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The company plans to launch the approved product in the U.S. market soon. The product is already approved and manufactured at Granules’ Gagillapur facility, near Hyderabad. The new approval will help strengthen market share and support business continuity through multi-site manufacturing, Granules said, without specifying the product.

“We plan on launching the product in 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,” Granules India CMD Krishna Prasad Chigurupati said in a release.

There are also other products filed from the same site and expect the U.S. FDA to approve them following necessary audits if required. “The development marks the first approval from Granules’ second Hyderabad facility with finished dosage capabilities,” he said.