Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Valsartan Tablets USP, 40mg, 80mg, 160mg and 320mg. The product is ready for launch. The company now has a total of 195 ANDA approvals (170 Final approvals including 7 from Aurolife Pharma LLC and 25 tentative approvals) from USFDA.
Valsartan Tablets USP, 40mg, 80mg, 160mg and 320mg are the generic equivalent to the reference listed drug product (RLD) Diovan Tablets, 40mg, 80mg, 160mg and 320mg respectively of Novartis Pharmaceuticals Corporation (Novartis) and indicated for the treatment of hypertension, to lower blood pressure. The product falls under the therapeutic category of CVS (Cardio Vascular) has a market size of approximately $2 billion for the twelve months ending October 2014 according to IMS.
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.
