Ambrisentan tablets would be manufactured at Zydus Cadila’s formulations manufacturing facility at SEZ, Ahmedabad.
New Delhi: Drug maker Zydus Cadila Friday said it has received the final approval from the US health regulator to market Ambrisentan tablets, used to treat high blood pressure in the lungs, in the American market.
The Ahmedabad-based group has received the approval from the US Food and Drug Administration (USFDA) to market the drug in strengths of 5 mg and 10 mg, Zydus Cadila said in a statement.
The product would be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. The sales of Ambrisentan tablets USP in the US market stood at USD 943 million (about Rs 6,500 crore) last year.
Zydus said it now has 258 approvals from the USFDA and has so far filed over 350 abbreviated new drug applications (ANDAs) since the commencement of its filing process in 2003-04.