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Zydus Cadila gets USFDA nod for diabetes drug Sitagliptin

Drug firm Zydus Cadila on Monday said it has received approval from the US health regulator to market Sitagliptin, a medicine indicated to treat diabetes.

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USFDA issues 3 observations to Zydus Lifesciences, Vadodara plant
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6 Sep 2021 5:07 PM GMT

New Delhi: Drug firm Zydus Cadila on Monday said it has received approval from the US health regulator to market Sitagliptin, a medicine indicated to treat diabetes. The company said its subsidiary has received tentative approval from the US Food and Drug Administration (FDA) for its new drug application for Sitagliptin base 25, 50 and 100 mg tablets.

Last year in October,The pharma company had filed a new drug application (NDA) with the USFDA seeking approval to market Sitagliptin base 25, 50 and 100 mg tablets. The NDA received tentative approval upon completion of the first review cycle on September 2, 2021, Zydus Cadila stated.

The firm discovers, develops, manufactures, and markets a broad range of healthcare therapies including small molecule drugs, biologic therapeutics, and vaccines.

Drug firm Zydus Cadila NDA new drug application 
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