Ranbaxy Laboratories Limited (Ranbaxy) has received approval from the US Food and Drug Administration to commercialize Minocycline Hydrochloride Tablets USP, 50 mg (base), 75 mg (base), and 100 mg (base). The Office of Generic Drugs, US Food and Drug Administration, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug. Total market sales for Minocycline were $206.5 million (IMS - MAT: September 2003).
Marketing of this product will be directed on an exclusive basis by Stiefel Laboratories Inc., located in Coral Gables, Florida, USA. "Efforts to provide an alternate dosage form to Stiefel's product portfolio utilizing Ranbaxy's technical skills demonstrates synergy between the two companies that has been gained through this strategic alliance," according to Dipak Chattaraj, president of Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy.
Charles W Stiefel, chairman, president and CEO of Stiefel Laboratories stated, "This is a cooperative effort between Stiefel and Ranbaxy that is mutually beneficial to both organizations and of value to prescribers and patients."
Based in Princeton, New Jersey, RPI is a wholly owned subsidiary of RLL, India having established operations in the US in 1994 and launching its first prescription product in January 1998, following FDA approval in August 1997. For the year 2002, US operations achieved sales of US $296 Mn, a growth of 162 per cent over the corresponding year. During 2002, RPI filed 23 ANDAs (surpassing its target of 15-20 ANDA filings annually) and received 11 approvals. RPI markets a basket of generic products covering major therapeutic areas. In 2002, RPI was ranked as the 9th largest company in the US generics market.