Healthcare player Zydus Cadila on Tuesday informed about receiving the final approval from the US Food and Drug Administration (USFDA) to market Olmesartan Medoxomil tablets in the US market.
The approval will allow the company to sell the drug in strengths of 5 mg, 20 mg and 40 mg. This is a day one approval after the expiry of 181 day exclusivity, Zydus said.
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), it added.
The group now has more than 110 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in fiscal 2003-04.
Cadila Healthcare (Zydus Cadila) shares were trading up by 1.26 per cent at Rs 456.90 on the BSE.