Unichem Laboratories gets USFDA’s nod for Metformin Hydrochloride Extended-Release Tablets

13 Aug 2021 Evaluate

Unichem Laboratories has received ANDA approval for its Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Glucophage XR Tablets, 500 mg and 750 mg, of EMD Serono Inc.

Metformin Hydrochloride Extended-Release Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The product will be commercialized from Unichem's Goa Plant.

Unichem Laboratories is an international, integrated, specialty pharmaceutical company.

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