Unichem Laboratories Limited 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) for a generic version of Januvia (sitagliptin) tablets, 25 mg, 50 mg, and 100 mg, of Merck Sharp 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.

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. In India, the company has strong skills in product development, process chemistry and manufacturing complex API as well as dosage forms.