The drug maker on Monday announced that its subsidiary has received tentative approval from the US drug regulator for its new drug application for sitagliptin base 25, 50 and 100 mg tablets.
The drug is an anti-diabetic medication used to treat type 2 diabetes. Zydus' sitagliptin base contains the active moiety sitagliptin in a different form than used in the branded reference product, Januvia (sitagliptin phosphate).On 31 October 2020, Zydus filed a New Drug Application (NDA) under section 505(b)(2) of the Federal Food and Drug Cosmetic Act (FD&C Act) with the United States Food and Drug Administration (USFDA) seeking approval to market sitagliptin base 25, 50 and 100 mg tablets. Subsequently, it received tentative approval upon completion of the first review cycle on 2 September 2021.
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies including small molecule drugs, biologic therapeutics, and vaccines.
On a consolidated basis, the drug major posted a 35.2% rise in net profit to Rs 635.50 crore on 14.4% rise in net sales to Rs 3,917.40 crore in Q1 FY22 over Q1 FY21.
Shares of Cadila Healthcare were down 0.02% at Rs 555.60 on BSE.
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