Granules Life Sciences Private Limited, a wholly owned subsidiary of Granules India Limited, has obtained its first approval from the US Food and Drug Administration (US FDA) for Metformin HCl tablets.

The product is already approved and manufactured at the company’s existing Gagillapur facility. The approval followed a Pre-Approval Inspection conducted in late July and early August 2025, during which the regulator issued one observation.

Granules plans to launch the approved product in the US market soon and aims to bolster its market share and ensure business continuity by implementing multi-site manufacturing. This latest milestone strengthens the company’s presence in the highly regulated US generics market and underscores its commitment to global expansion and regulatory compliance.