Granules India gets USFDA nod to Metformin Hydrochloride ER tablets for diabetes management
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New Delhi: Drug firm Granules India on Wednesday said it has received the US health regulator's approval for Metformin Hydrochloride extended-release (ER) tablets, used in the management of type-2 diabetes.
The approved product is the generic equivalent of Glumetza ER tablets, 500 mg and 1000 mg, of Bausch Health US LLC.
The US Food and Drug Administration (USFDA) has granted final approval for the company''s abbreviated new drug application (ANDA) for Metformin Hydrochloride extended-release tablets USP, 500 mg and 1000 mg, Granules said in a regulatory filing.
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