Zydus Cadila has received tentative approval from the US health regulator to market Sitagliptin tablets, indicated for treating diabetes, in the American market. The company has received tentative approval from the United States Food and Drug Administration (USFDA) for Sitagliptin tablets in strengths of 25 mg, 50 mg, and 100 mg, Zydus Cadila said in a BSE filing.
Cadila Healthcare is an Indian pharmaceutical company headquartered at Ahmedabad in Gujarat state of western India. It said the drug will be produced at the group’s formulations facility at SEZ, Ahmedabad.
The group has more than 217 approvals, and so far filed over 330 abbreviated new drug applications (ANDAs).