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Wockhardt receives USFDA’s final approval for Alfuzosin hydrochloride tablets

14 Aug 2012 Evaluate

Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 10mg extended release tablets of Alfuzosin hydrochloride, which is used in treatment of Benign Prostatic Hyperplasia or enlarged prostate. Alfuzosin is the generic name for the brand Uroxatral, marketed in the United States by Sanofi-Aventis. The company would be launching this product immediately.

According to IMS Health, the total market for this product in the US is about $81.5 million. Wockhardt will be manufacturing Alfuzosin hydrochloride API in its facility at Ankleshwar, India and the extended release tablets of Alfuzosin at its facility in Aurangabad, India. The technology for the API and the capsules were developed in-house.

Wockhardt is one of the few companies with end to end integrated capabilities for its products, starting with the manufacture of the oral and sterile API’s , the dose forms and marketing through wholly owned subsidiary in the US, enabling the company to capture maximum value.

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