Ranbaxy Laboratories Limited (RLL) has received tentative approval from the Food and Drug Administration, USA, for manufacturing and marketing, Fluconazole for Oral Suspension, 10 mg/ml and 40 mg/ml to the reference listed drug Diflucan for Oral Suspension of Pfizer Central Research. Sales for Fluconazole for Oral Suspension totaled $23.9 Mn (IMS, MAT - April 2003), which represents 3.5% of the total $682.9 Mn market for Fluconazole.

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 and marketing for this product will be supported by the Sales and Marketing Group of Ranbaxy Pharmaceuticals Inc. (RPI), and the product will be made available to dispensing outlets throughout USA, including chain pharmacies, wholesalers, and generic distributors.

According to Dipak Chattaraj, President, RPI, "Adding an anti-fungal molecule as a liquid formulation to our expanding product portfolio reflects our breadth of expertise and demonstrates our commitment to bring generic alternatives to the U.S. healthcare system that have clinical utility and value to prescribers and patients."

The Company had recently received tentative approval for manufacturing and marketing, Fluconazole Tablets, 50 mg, 100 mg, 150 mg, and 200 mg.