Granules India Arm Gets US FDA Nod for Product from Hyderabad, India Unit

MT Newswires Live

2025/11/11

Granules Life Sciences, a wholly-owned subsidiary Granules India (NSE:GRANULES, BOM:532482) has received US Food and Drug Administration (US FDA) approval for a product that was the subject of a pre-approval inspection (PAI) at its unit in Hyderabad, India, according to a Tuesday filing to the Indian stock exchanges.

The inspection was conducted between July 28 and Aug. 1, which conculded with was one observation during that inspection.

With this approval, the Granules Life facility is now deemed approved by the US FDA. It is the first approval from the American regulator for the Granules Life site.

The same product is already approved and manufactured at Granules' Gagillapur facility and the company plans to launch the approved product in the US market soon.

The comapny's shares were down over 1% in recent trade.

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