Aurobindo Pharma has received final approval from the US Food & Drug Administration (US FDA) to manufacture and Quinapril tablets USP 5mg, 10mg, 20mg and 40mg (ANDA 202725).
Quinapril Tablets USP 5mg, 10mg, 20mg and 40mg is the generic equivalent of Pfizer Pharmaceutical’s Accupril tablets 5mg, 10mg, 20mg and 40mg respectively, indicated for the treatment of hypertension and falls under the Cardiovascular (CVS) therapeutic category. The market size of the product is estimated to be $49 million for the twelve months ending September 2012 according to IMS.
The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad.
Aurobindo now has a total of 188 ANDA approvals (161 final approvals including four from Aurolife Pharma and 27 tentative approvals) from US FDA.
EP News Bureau – Mumbai
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