Ranbaxy Pharmaceuticals Inc (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), has received final approval from the U.S. Food and Drug Administration to manufacture and market Amoxicillin for Oral Suspension USP, 200 mg/5 ml and 400 mg/5 ml. Based on bioequivalent studies, the formulation has been deemed to be bioequivalent and therefore therapeutically equivalent to Amoxil for Oral Suspension 200 mg/5 ml and 400 mg/5 ml manufactured by GlaxoSmithKline.

Amoxicillin is indicated in the treatment of infections due to susceptible strains of the designated micro-organisms in the following conditions: infections of the ear, nose and throat, the genitourinary tract, the skin and skin structure, the lower respiratory tract, gonorrhea and acute uncomplicated (ano-genital and urethral) infections, and H. pylori eradication to reduce the risk of duodenal ulcer recurrence.

Amoxicillin is ranked second in antibiotic sales in the U.S. market. The total Amoxicillin market is estimated to be $ 235.4 million with suspensions accounting for $ 104.1 million and the Amoxicillin in both the 200 and 400 mg per 5 ml strengths totalling $ 63.4 million (IMS - MAT, Sept. 02). The approval received by Ranbaxy represents the first approval for any generic company to market this dosage form as an alternative to the brand. RPI has already received approvals for other forms of Amoxicillin viz: Amoxicillin 500mg & 875mg tablets; 250 mg & 500 mg capsules; 125 mg & 250 mg chewable tablets. With this new approval RPI is uniquely positioned to offer multiple dosage forms of Amoxicillin that includes capsules, tablets, chewable tablets, and suspensions in multiple strengths and package sizes. By offering these additional strengths as a liquid, RPI will provide pharmacists with a cost effective, generic alternative that will meet the clinical needs of the patient/care giver and support the prescribing patterns of physicians.

This product was developed and will be manufactured at RLL in their dedicated facilities to support the market requirements for this product. RLL is a backwardly integrated company and all aspects of the Active Pharmaceutical Ingredient (API) and formulation and development are undertaken utilizing the capabilities and competencies residing within RLL.

Sales and marketing for this product will be supported by the Ranbaxy sales and marketing group and product will be made available to all dispensing outlets located throughout the U.S. including chain pharmacies, wholesalers, and generic distributors. Product will be made available as soon as inventories are achieved to support market requirements.

According to Dipak Chattaraj, President of RPI, "We were delighted to make yet another dosage form of Amoxicillin available based on the skills and talents that are available through our parent company, Ranbaxy Laboratories Limited. This again demonstrates our depth and breadth of expertise to add to our expanding product portfolio, along with our commitment to bring generic alternatives to the U.S. healthcare system. We are adding yet another product that has clinical utility and value, and as such, will distinguish Ranbaxy in the years to come."