Indian pharmaceutical major Zydus Cadila has received final nod for its anti-hypertensive drug Olmesartan Medoxomil from USFDA, the company said in a BSE filing on Tuesday.
The drug will be produced at the group’s formulations manufacturing facility at the pharma SEZ in Ahmedabad.
The estimated sales of Olmesartan is $982 million.
With this latest approval, Zydus Cadila 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.
Zydus Cadila is one of the top pharma companies in India. Recently, the group launched Exemptia, the world’s first biosimilar for Adalimumab, the largest selling therapy worldwide for inflammatory arthritis.
Zydus is also the only Indian pharma company to launch its own patented NCE – Lipaglyn, the world’s first drug to be approved for the treatment of diabetic dyslipidemia.