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Granules India climbs after USFDA approval for type 2 diabetes drug

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Granules India gained 2.21% to Rs 369.50 after the company said it received US drug regulator's approval of metformin hydrochloride ER tablets USP, 500 mg and 1000 mg.

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. The product is generic equivalent of Glumetza ER tablets of Bausch Health US LLC (Bausch). Glumetza is a trademark of Salix Pharmaceuticals, Inc. or its affiliates.

The drug is 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 USFDA (34 final approvals and 1 tentative approval).

Granules India is a pharmaceutical manufacturing company. The company produces Finished Dosages (FDs), Pharmaceutical Formulation Intermediates (PFIs) and Active Pharmaceutical Ingredients (APIs) which gives the customers flexibility and choice.

On a consolidated basis, Granules India reported 70.8% jump in net profit to Rs 164 crore on a 22.7% rise in income from operations to Rs 858 crore in Q2 FY21 over Q2 FY20.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

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First Published: Wed, January 13 2021. 12:00 IST