The Hindu Business Line : Ranbaxy gets US nod to make, market Cefprozil

Ranbaxy Laboratories Ltd said it has US Food and Drug Administration (US FDA) approval to manufacture and market Cefprozil tablets. The drugs will come in 250 mg and 500 mg, and treat pharyngitis or tonsillitis, otitis media, acute sinusitis, bronchitis and uncomplicated skin infections.

According to the company, the total annual market sales for Cefprozil tablets are $76.6 million.

A statement released by the company quotes Mr Jim Meehan, Vice-President of Sales and Marketing of its wholly owned subsidiary Ranbaxy Pharmaceuticals Inc based in Jacksonville, Florida, stating that this represented yet another addition to their product portfolio of anti-infectives, that will be available as an affordable generic alternative to the brand equivalent.

The company claims that the US FDA has determined its formulations to be bioequivalent and have the same therapeutic effect as that of Cefzil, a registered trademark of Bristol Myers Squibb Company Pharmaceutical Research Institute.

The formulation is to be produced in their facility located in Dewas, in Madhya Pradesh. The company plans to bring the product to the US market in early 2007.

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