Unichem Labs diabetes drug Sitagliptin gets USFDA approval

Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Published On 2021-07-11 06:30 GMT   |   Update On 2021-07-11 06:30 GMT
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Mumbai: Unichem Laboratories Limited has recently announced that the company has received tentative approval for Abbreviated New Drug Application (ANDA) of Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg from the United States Food and Drug Administration (USFDA).

The product is a generic version of Januvia (sitagliptin) tablets, 25 mg, 50 mg, and 100 mg, of Merck Sharpe and Dohme Corp (Merck).

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Read also: Unichem Labs gets USFDA nod for Amitriptyline HCl Tablets

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.

Read also: Unichem Labs secures USFDA nod for Aripiprazole Tablets

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.




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