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Our Bureau

New Delhi, Oct. 30 Dabur Pharma Ltd, the Delhi-based company specialising in cancer treatment drugs, has received tentative approval to market the generic version of Pfizer’s Camptosar (Irinotecan Hydrochloride) injection.

The company said in a statement that the US Food and Drug Administration had granted it tentative approval for two strengths of its Abbreviated New Drug Application.

Irinotecan has sales of over $500 million in the US and the approval provides Dabur Pharma with a big business opportunity. The company expects to start marketing the drug in the US upon expiry of Pfizer’s Camptosar’s patent in February 2008.

“This marks a major milestone for Dabur Pharma, which is vertically integrated in the product and is already one of the largest producers of Irinotecan Active Pharmaceutical Ingredient in the world. The company is one of the most cost effective producers of Irinotecan and the approval and subsequent launch will provide a quantum jump to our aggressive growth plans,” said Mr Ajay Kumar Vij, CEO, Dabur Pharma.

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