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Ranbaxy Labs gets USFDA approval for Cefprozil
Ranbaxy Laboratories received an approval from the US Food and Drug Administration to manufacture and market Cefprozil Tablets USP, in 250 mg and 500 mg strengths.
The office of generic drugs, US Food and Drug Administration, concluded that the company`s formulations are bioequivalent and have the same therapeutic effect as that of Cefzil tablets, 250 mg and 500 mg, respectively, of Bristol Myers Squibb Company Pharmaceutical Research Institute.
Cefprozil Tablets are suggested 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.
The company plans to bring this product to the market in early 2007, said Jim Mcehan, vice president of sales and marketing for RPI, USA.
Ranbaxy Pharmaceuticals (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.
Shares of the company closed up Rs 4.05, or 1.10%, at Rs 370.80 Thursday. Total volumes of shares traded were 120,849.