by NR Indran / INT

MUMBAI : Pharmaceutical and biotechnology major Wockhardt has receivedtentative approval from the United States Food & Drug Administration (US FDA)for marketing 20mg, 30mg and 60mg delayed release capsules of Duloxetinehydrochloride which is used in treatment of depression. Duloxetine is thegeneric name for the brand Cymbalta, marketed in the United States by EliLilly and Company. The patent covering this product is under litigation in theUS courts and Wockhardt will launch the product after resolution of the same.According to IMS Health, the total market for this product in the US is about$3.3 billion.

“Wockhardtwas amongst the first-to-file companies with a paragraph-IV certification forDuloxetine DR capsules” said Wockhardt Chairman Habil Khorakiwala. “We will nowbe amongst the first-to-market this product, as and when the generic marketopens up. Wockhardt plans to sustain its rapid growth in the US market througha series of such first-to-market launches”, he commented further.

Duloxetine is amongst the most widely used drugs in treatingdepression and generalized anxiety disorder.

In the US generic pharmaceutical market, Wockhardt has beenconsistently growing market shares for all its products. In many instances,Wockhardt, by virtue of being amongst the first to market, has reaped theadvantage of being an early entrant.

Wockhardtwill be manufacturing the Duloxetine HCl API at its FDA approved facility inAnkleshwar, Gujarat and the capsules at its facility in Aurangabad. Thetechnology for the API as well as for the delayed release capsules wasdeveloped in-house.

Wockhardtis one of the few companies with end-to-end integrated capabilities for itsproducts, starting with manufacture of the oral and sterile API’s, the doseforms and marketing through the wholly-owned subsidiary in the US, enabling thecompany to capture maximum value.

Wockhardt is ahigh technology global pharmaceuticals and biotechnology major with innovativemulti-disciplinary research and development programmes. It has 5 researchcentres and 21 world-class manufacturing plants in India, USA, UK, France andIreland. Wockhardt has a multi-ethnicworkforce of over 6500 people from 14 different nationalities.

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