Wockhardt gets US FDA nod for Bupropion HCI

03 Sep 2012 Evaluate

Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 100mg, 150mg and 200mg 12-Hr extended release tablets of Bupropion HCI, which is used in the treatment of depression. Bupropion is the generic name for the brand Wellbutrin SR, marketed in the US by Glaxo Smithkline. The company is launching the product immediately.

The total market for this product in the US is about $268 million. Depression is a rapidly growing condition globally and Bupropion is one of the more used drug for treating this condition.

In the US generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. The company will be manufacturing the extended release tablets of Bupropion 12-Hr at its facility in Walju in India. The technology for the tablets was 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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