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.
