Unichem Laboratories Limited Approval for ANDA from United States Food and Drug Administration (USFDA) for Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg.

 

Unichem Laboratories Limited is pleased to announce 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) for a 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.

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