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Aurobindo Pharma Ltd has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Telmisartan tablets.
The approved Abbreviated New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product Micardis tablets of Boehringer Ingelheim Pharmaceuticals, Inc.
The drug is indicated for the treatment of essential hypertension and has an estimated market size of $92 million for the 12 months ended July 31, 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,''’ the Hyderabad-based company said in a release issued here on Friday.
Aurobindo now has 211 ANDA approvals (183 final approvals, including 9 from Aurolife Pharma LLC and 28 tentative approvals) from the US regulator.
Aurobindo’s scrip lost 1.52 per cent and was trading at Rs 724.20 after the noon on the Bombay Stock Exchange on Friday.
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