Zydus gets USFDA tentative nod for Empagliflozin Tablets
Ahmedabad: Zydus Cadila has received tentative approval from the USFDA to market Empagliflozin Tablets, in the strengths of 10 mg and 25 mg (US RLD: Jardiance® Tablets).
The medication is used together with diet and exercise to improve blood sugar control in adults with Type 2 diabetes mellitus. It is also used to reduce the risk of cardiovascular death in adult patients with Type 2 diabetes mellitus and established cardiovascular disease.
The drug will be manufactured at the group's manufacturing facility at SEZ, Ahmedabad.
The group now has 286 approvals and has so far filed over 386 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Cadila is an innovative, global pharmaceutical company headquartered in Ahmedabad, India. The company discovers, develops, manufactures and markets a broad range of healthcare therapies.
The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.