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Drug maker Aurobindo Pharma Ltd today said the company has received final approval from the US health regulator to manufacture and market Quinapril tablets in the American market.
The company has received the approval from the US Food and Drug Administration (USFDA) to manufacture the drug, which is indicated for the treatment of hypertension and falls under the cardiovascular (CVS) therapeutic category, in strengths of 5mg, 10mg, 20mg and 40mg, it said in a release.
The market size of the product is estimated to be $49 million for the 12 months ended September 2012, according to IMS, it said.
The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad, it said.
Aurobindo now has a total of 188 ANDA approvals (161 final approvals including 4 from Aurolife Pharma LLC and 27 tentative approvals) from USFDA, the release added.
Shares of Aurobindo were quoting at Rs 187.70 apiece, down 2.24%, in the late afternoon trade on the BSE.
