Ranbaxy granted final USFDA approval to manufacture & market Cefprozil Anti-Infective Tablets

Ranbaxy Laboratories Ltd on December 14, 2006 has announced that the Company has received approval from the US Food and Drug Administration to manufacture and market Cefprozil Tablets USP, 250 mg and 500 mg. The Office of Generic Drugs, US Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Cefzil® Tablets, 250 mg and 500 mg, respectively, of Bristol Myers Squibb Company Pharmaceutical Research Institute. Total annual market sales for Cefprozil Tablets were $76.6 million (IMS - MAT: September 2006).

Cefprozil Tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in certain conditions, including: Pharyngitis / tonsillitis, Otitis Media, Acute Sinusitis, secondary bacterial infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis and uncomplicated skin and skin-structure infections.

"Ranbaxy is pleased to be granted approval for Cefprozil tablets which represents yet another addition to our ever-growing product portfolio of anti-infectives that will be available as an affordable generic alternative to the brand equivalent. This formulation will he produced in our cGMP compliant, cephalosporin dedicated facility located in Dewas, India. Our plans are to bring this product to the market in early 2007 during the height of the respiratory season," according to Jim Mcehan, Vice President of Sales and Marketing for RPI, USA.

Ranbaxy Pharmaceuticals Inc (RPI) based in Jacksonville, Florida, USA, is a wholly owned subsidiary of the Company. RPI is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.

Source : Equity Bulls

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