Unichem Labs gets USFDA nod for Metformin Hydrochloride ER Tablets
Mumbai: Drugmaker, Unichem Laboratories Limited, has recently announced that the company has received Abbreviated New Drug Application (ANDA) approval for its Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg from the United States Food and Drug Administration (USFDA).
The product is 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.
Read also: Unichem Labs diabetes drug Sitagliptin gets USFDA approval
Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company.
It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in several markets across the world.
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