Granules India share price up 3% on USFDA approval

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Granules India share price added 3 percent intraday on January 13 after the company received an approval from the US Food & Drug Administration (US FDA).

Company announced that the 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 LLC (Bausch).

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 tablets had US sales of approximately USD 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, Inc. or its affiliates.

At 12:12 hrs Granules India was quoting at Rs 368.45, up Rs 6.90, or 1.91 percent on the BSE.

The share touched its 52-week high Rs 438.00 and 52-week low Rs 114.50 on 01 December 2020 and 23 March 2020, respectively.