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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.
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751