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Aurobindo Pharma receives USFDA Approval for Flecainide Acetate Tablets

10 Jul 2015 Evaluate

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Flecainide Acetate Tablets USP 50 mg, 100 mg and 150 mg (ANDA 202821). The company will commence shipping shortly. This is the 40th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-betalactam products.

Flecainide Acetate Tablets are an antiarrhythmic agent with an estimated market size of $61 Million for the twelve months ending April 2015. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Tambocor Tablets, 50 mg, 100 mg, 150 mg.

Aurobindo is a 'Vertically Integrated' pharmaceutical companies in India, It has robust product portfolio spread over major product areas encompassing CVS, CNS, Anti-Retroviral, Antibiotics, Gastroenterologicals, Anti-Diabetics and Anti-Allergic with approved manufacturing facilities by USFDA, UKMHRA, WHO, MCC-SA, ANVISA-Brazil for both APIs & Formulations.

Aurobindo Pharma Share Price

1371.90 -13.75 (-0.99%)
20-Apr-2026 12:47 View Price Chart
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