The nod by US Food and Drug Administration (USFDA) is for multiple strengths of the tablets 5mg/40mg; 10mg/20mmg and 10mg/40 mg, the company said in a BSE filing.
"The drug is indicated for the treatment of hypertension, alone or with other anti-hypertensive agents to lower blood pressure and will be manufactured at the group's formulations manufacturing facility at Pharma SEZ Ahmedabad," Cadila Healthcare added.
The group has now more than 150 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs) since the commencement of filing process in FY2003-04, it added.