Zydus Cadila gets tentative USFDA nod for Linagliptin and Metformin Hydrochloride tablets
New Delhi: Drug firm Zydus Cadila Friday said it has received tentative approval from the US health regulator to market Linagliptin and Metformin Hydrochloride tablets, used to control of blood sugar levels in diabetic patients.
The United States Food and Drug Administration (USFDA) has granted tentative approval to market the drug in strengths of 2.5 mg/500 mg, 2.5 mg/850 mg and 2.5 mg/ 1,000 mg, Cadila Healthcare said in a BSE filing.
Zydus Cadila said the drug will be produced at the group's formulations manufacturing facility at special economic zone (SEZ), Ahmedabad.
The group has more than 221 approvals, and so far filed over 330 abbreviated new drug applications (ANDAs) since it started filings in 2003-04.