Ranbaxy Pharmaceuticals Inc (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced that RLL has received tentative approval from the Food and Drug Administration for Fluconazole Tablets, 50 mg, 100 mg, 150 mg, and 200 mg to the reference listed drug Diflucan Tablets of Pfizer Central Research.

Diflucan (Fluconazole) is indicated for the treatment of vaginal candidiasis (vaginal yeast infections due to Candida), oropharyngeal and esophageal candidiasis, and cryptococcal meningitis. Fluconazole is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.

Sales for Fluconazole Tablets totaled $422.2 million (IMS, MAT - December 2002), which represents 68% of the total $624.7 million market for Fluconazole.

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.

According to Dipak Chattaraj, President of RPI, "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."

For the year 2002, US operations achieved sales of US$296 Mn, a growth of 162% over the corresponding year. During 2002, RPI filed 23 ANDAs (surpassing its target of 15-20 ANDA filings annually) and received 11 approvals taking the cumulative number of approvals to 65 with 31 awaiting approvals. RPI markets a basket of generic products covering major therapeutic areas. RLL established operations in the U.S. in 1994 and launched its first prescription product, following FDA approval, in January 1998. Today, RPI is the 9th largest in the US generics market.