Unichem Laboratories announced that it has received tentative approval for ANDA of Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg from the United States Food and Drug Administration (USFDA).
The product is generic version of Januvia (sitagliptin) tablets, 25 mg, 50 mg, and 100 mg, of Merck Sharpe and Dohme Corp (Merck).
Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Product will be commercialized from Unichem's Goa Plant on receipt of full approval.
The announcement was made on Saturday, 10 July 2021. Shares of Unichem Laboratories fell 0.2% to settle at Rs 327.80 on Friday, 9 July 2021.
Unichem Laboratories 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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