Mumbai: Ranbaxy Laboratories Ltd 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 FDA, 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.
Ranbaxy Pharmaceuticals Inc (RPI), the US arm of the Indian pharmaceutical major, will market the tablets in the US. Cefprozil tablets had total annual sales of $76.6 million last year.
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.
Cefprozil tablets represent another addition to Ranbaxy's product portfolio of anti-infectives that are affordable generic alternatives to their brand equivalents. This formulation will he produced at Ranbaxy's cGMP compliant, cephalosporin dedicated facility in Dewas, the company said in a filing with the Bombay Stock Exchange. (BSE).
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.