Wockhardt receives USFDA's tentative approval for Duloxetine hydrochloride

08 Jul 2011 Evaluate

Pharmaceuticals and biotechnology major Wockhardt has received tentative approval from the United States Food & Drug Administration (USFDA) for marketing 20 mg, 30 mg and 60 mg delayed release capsules of Duloxetine hydrochloride which is used in the treatment of depression.

Duloxetine is the generic name for the brand Cymbalta marketed in the United States by Eli Lilly and Company. The patent covering is under litigation in the US courts and the company will launch the product after resolution of the same. According to IMS Health, the total market for this product in US is about $3.3 billion.

Duloxetine is amongst the most widely used drug in treating depression and generalized anxiety disorders. The company would be manufacturing Duloxetine HCI API at its FDA approved facility in Ankleshwar, Gujarat and the capsules at its facility in Aurangabad. Further, the technology for the API as well as for the delayed release capsules 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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