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Zydus Cadila arm gets USFDA nod for Sitagliptin base tablets

Published On 2021-09-06T11:00:21+05:30  |  Updated On 2021-09-06T18:26:26+05:30
Zydus Cadila arm gets USFDA nod for Sitagliptin base tablets

Overview

Ahmedabad: Drugmaker, Zydus Cadila, today announced that the company's subsidiary has received tentative approval from the United States Food and Drug Administration (USFDA) for its new drug application for Sitagliptin base 25, 50 and 100 mg tablets.

Zydus' Sitagliptin base contains the active moiety Sitagliptin in a different form than used in the branded reference product, Januvia (Sitagliptin Phosphate). On October 31, 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.

Zydus' NDA received tentative approval upon completion of the first review cycle on September 2, 2021.

Read also: Zydus needle-free COVID vaccine ZyCoV-D expected to be available from October

Zydus Cadila is a global pharmaceutical company headquartered in Ahmedabad, India.

The company discovers, develops, manufactures, and markets a broad range of healthcare therapies.
Read also: Zydus Cadila gets USFDA nod for Tofacitinib ER tablets





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ruchika

Ruchika joined Medical Dialogue an Desk Editor for the Business Section in 2019. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate from Delhi University. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
zydus cadila zydus cadila news sitagliptin base tablets usfda januvia 
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