PARSIPPANY, N.J. and MUMBAI, India, June 22, 2015 /PRNewswire/ -- Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 5mg/ 5ml of Oxycodone HCl liquid which is used in treatment of moderate to severe acute and chronic pain. Wockhardt is launching the product soon and will be amongst the few generic versions of this product in the market.
"We are delighted to receive this ANDA approval for our Oxycodone liquid," said Dr. Habil Khorakiwala, Wockhardt Founder Chairman & Group CEO. "We have filed several ANDA's over the last couple of years from our Morton Grove Pharmaceuticals facility in Illinois, USA, especially for liquid products. This is only the first of few others we expect soon," he said.
According to IMS Health, the total market for this product in the US is about $58 million. Oxycodone is used extensively in management of pain, especially in opioid tolerant patients. Wockhardt already markets several other controlled substance products in the United States and generally has a leading presence in the liquid formulations segment.
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 Oxycodone HCl liquid at its facility in Morton Grove, IL. The technology for the product was developed in-house.
Wockhardt is a Research based and technology intensive global pharmaceutical and biotechnology company. It's multi-disciplinary and innovative R&D programmes globally, are strongly focused on creating Intellectual Properties. 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 72% of its global revenues coming from international businesses. With a large pool of Patents and Intellectual Property knowhow, Wockhardt is home to 850 scientists, of whom 80 are doctorates. In all, Wockhardt has 341 Patents granted worldwide. In biotechnology research, it has built competent 'Concept to Market' capability in all facets of development and manufacture of recombinant biopharmaceuticals. Wockhardt boasts of a multi-ethnic workforce of more than 8,600 people from 21 different nationalities.
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