Wockhardt receives tentative approval from USFDA for generic version of Geodon

22 Aug 2012 Evaluate

Pharmaceutical and biotechnology major Wockhardt has received tentative approval from US Food and Drug Administrator (USFDA) for marketing a generic version of 20mg, 40mg, 60mg & 80mg capsules containing Ziprasidone hydrochloride, which is used in the treatment of bipolar disorders and schizophrenia. The company will be launching the product on September 02, 2012.

Ziprasidone capsule is the generic name for the brand Geodon, marketed in the US by Pfizer. According to IMS Health, the total market for this product in the US is about $1.3 billion.

Wockhardt will be manufacturing the Ziprasidone HCI API in its facility located at Ankleshwar in India and the capsules of Ziprasidone at its facility located at Aurangabad in India. The technology for the API and the capsules were developed in-house.

This is the fifth USFDA approval for Wockhardt in the past 8 days. In the US generic pharmaceutical market, the company has been consistently growing market shares for all its products.

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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