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.
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