Aurobindo Pharma Limited on Septmebr 4, 2015 announced that it has received the final approval from the US Food & Drug Administration (US FDA) to manufacture and market telmisartan tablets USP 20mg, 40mg, and 80mg.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Micardis tablets of Boehringer Ingelheim Pharmaceuticals Inc. Telmisartan tablet is indicated in the treatment of essential hypertension and has an estimated market size of $ 92 mllion for the twelve months ending July 2015, according to IMS.
This is the 46th ANDA to be approved out of unit VII formulation facility in Hyderabad for manufacturing oral non-antibiotic products. Aurobindo now has a total of 211 ANDA approvals (183 final approvals including 9 from Aurolife Pharma LLC and 28 tentative approvals) from US FDA.
