Aurobindo Pharma gets USFDA approval for Telmisartan Tablets

04 Sep 2015 Evaluate

Aurobindo Pharma has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Telmisartan Tablets USP 20mg, 40mg, and 80mg (ANDA 206511). The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Micardis Tablets of Boehringer Ingelheim Pharmaceuticals.

Telmisartan Tablets are indicated in the treatment of essential hypertension and has an estimated market size of $92 Million 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, India 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 USFDA.

Aurobindo Pharma, headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, Japan PMDA, WHO, Health Canada, MCC South Africa, ANVISA Brazil.


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