Zydus Cadila has got the tentative approval from the US health regulator for marketing anti-diabetic sitagliptin and metformin hydrochloride in the US market.
Cadila Healthcare has said in a BSE filing that the company has received tentative approval from the United States Food and Drug Administration (USFDA) to market sitagliptin and metformin hydrochloride in the strength of 50mg/500 mg and 50mg/1000 mg.
It further said that the group has now nearly 120 approvals from the USFDA and so far filed 300 abbreviated new drug applications (ANDAs).