Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market its Quinapril Tablets USP 5mg, 10mg, 20mg and 40mg (ANDA 202725). Quinapril Tablets USP 5mg, 10mg, 20mg and 40mg is the generic equivalent of Pfizer Pharmaceuticals’ 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, India. Aurobindo now has a total of 188 ANDA approvals (161 Final approvals including 4 from Aurolife Pharma LLC and 27 Tentative approvals) from USFDA.
Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s robust product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics, supported by an outstanding R&D set-up.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1675.20 |
| Dr. Reddys Lab | 1235.40 |
| Cipla | 1238.30 |
| Zydus Lifesciences | 942.55 |
| Lupin | 2324.25 |
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