Aurobindo Pharma has received final approval from US health regulator to make and sell in America the generic Telmisartan tablets used for treating hypertension.
“The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Telmisartan tablets USP in the strengths of 20mg, 40mg, and 80mg,” Aurobindo Pharma said in a statement.
The approved Abbreviated New Drug Application (ANDA) is bioequivalent to Boehringer Ingelheim Pharmaceuticals Inc’s Micardis tablets, it added.
Telmisartan tablets are indicated in the treatment of essential hypertension and has an estimated market size of USD 92 million for the 12 months ending July 2015 according to IMS health, Aurobindo Pharma said.
“This is the 46th ANDA to be approved out of Unit VII formulation facility in Hyderabad for manufacturing oral non- antibiotic products,” it added.
Aurobindo now has a total of 211 ANDA approvals (183 final approvals including 9 from Aurolife Pharma LLC and 28 tentative approvals) from the USFDA, the company said.
The company’s stock was trading at Rs 721.80, down 1.85 per cent, on the BSE.