Aurobindo Pharma Ltd. announced the obtaining of final approval from the US FDA to manufacture and market of Quinapril tablets USP 5mg, 10 mg, 20mg and 40mg covered under ANDA 202725.
Quinapril tablets USP 5mg, 10 mg, 20mg and 40mg is the generic equivalent of Pfizer Pharmaceuticals Ltd.'s Accupril tablets 5mg, 10 mg, 20mg and 40mg respectively.
Quinapril tablets 5mg, 10 mg, 20mg and 40mg are indicated for the treatment of hypertension and fall under the Cardiovascular (CVS) therapeutic category.
At the IMS data, the market size of the product was estimated to be $49 million for the twelve months ended September 2012.
The company said the product had been approved out of Unit VII (SEZ) formulations facility in Hyderabad, India.
At the BSE, Aurobindo Pharma shares are currently trading at Rs.188.95, down 1.59 percent from the previous close.
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