Zydus Cadila has received the final approval from the US FDA to market olmesartan medoxomil tablets in strengths of 5 mg, 20 mg and 40 mg. This is a day one approval after the expiry of 181 day exclusivity.
The drug is an anti-hypertensive and will be produced at the group’s formulations manufacturing facility at the Pharma SEZ in Ahmedabad. The estimated sales for olmesartan is $982 million (IMS MAT February 2017).
The group now has more than 110 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.