Sun Pharmaceutical Industries Ltd.

Sun Pharmaceutical Industries’ subsidiary  has been granted two tentative approvals by USFDA for its Abbreviated New Drug Applications (ANDA) for generic version of Januvia, Sitagliptin Tablets and generic version of Glumetza, Metformin HCI Extended-release tablets. Sitagliptin tablets, 25 mg, 50 mg and 100 mg are therapeutic equivalents of Merck Sharp & Dohme Corporation’s Januvia tablets. Sitagliptin tablets have annual sales of approximately $2.7 billion in the US. Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus.

Metformin HCI Extended-release tablets, 500 mg and 1000 mg are therapeutic equivalents of Santarus Inc.’s Glumetza tablets. Metformin HCI Extended-release tablets have annual sales of approximately $140 million in the US. Metformin HCI Extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus.

Sun Pharmaceuticals Industries 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 India, US and several other markets across the world.