Wockhardt Receives Tentative FDA Approval for Generic Version of Anti-Psychotic Drug Geodon®
8/22/2012 10:05:43 AM
PARSIPPANY, N.J. and MUMBAI, India, Aug. 22, 2012 /PRNewswire/ -- Pharmaceutical and biotechnology major Wockhardt has received tentative US FDA approval 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. Ziprasidone capsule is the generic name for the brand Geodon®, marketed in the US by Pfizer. Wockhardt will launch the product on Sept 02, 2012.
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According to IMS Health, the total market for this product in the US is about $1.3 billion.
"This is the fifth US FDA approval for Wockhardt in the past 8 days," said Dr. Habil Khorakiwala, Wockhardt Founder Chairman & Group CEO. "Wockhardt's R&D has ensured a steady stream of new products, which has translated into a varied product offering in the US markets," he further added.
In the US generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. In many instances, Wockhardt, by virtue of being amongst the few players to market technically challenging products has reaped the advantage of being an early entrant.
Wockhardt will be manufacturing the Ziprasidone HCl API in its facility at Ankleshwar, India and the capsules of Ziprasidone at its facility in Aurangabad, India. The technology for the API and the capsules were developed in-house.
Wockhardt is a high-technology intensive global pharmaceutical and biotechnology company with multi-disciplinary and innovative R&D programmes. It has 3 research centres globally and manufacturing facilities across India, USA, UK and Ireland. Wockhardt has a significant presence in USA, Europe and India, with 75% of its global revenues coming from international businesses. With a large pool of Patents and Intellectual Property knowhow, Wockhardt is home to 578 scientists, of whom 80 are doctorates. In all, Wockhardt has 164 Patents granted worldwide. In biotechnology research, it has built a competent 'Concept to Market' capabilities in all facets of development and manufacture of recombinant biopharmaceuticals. Wockhardt boasts of a multi-ethnic workforce of more than 7,900 people from 21 different nationalities.
Geodon® is a registered trademark of Pfizer Inc..
Visit us at: www.wockhardt.com