Granules India gets USFDA approval of Metformin Hydrochloride ER Tablets

Granules India announced that the US Food & Drug Administration (US FDA) has granted final approval for its Abbreviated New Drug Application (ANDA) for Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 1000 mg, generic equivalent of Glumetza ER Tablets, 500 mg and 1000 mg, of Bausch Health US.

Metformin Hydrochloride ER Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Metformin Hydrochloride ER Tablets had US sales of approximately $192 million for the most recent twelve months ending in November 2020 according to IQVIA Health.

Granules now has a total of 35 ANDA approvals from US FDA (34 final approvals and 1 tentative approval). Glumetza is a trademark of Salix Pharmaceuticals or its affiliates.