Ranbaxy Laboratories Limited (Ranbaxy) has received approval from the US Food and Drug Administration to manufacture and commercialize Metformin HCl Oral Solution 100 mg/mL under the brand name Riomet, stated a company release.
This New Drug Application (NDA) provides for the use of Riomet (Metformin HCl) Oral Solution as monotherapy as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. It will offer an alternate dosage form to the tablet dose that has been in the U.S. marketplace for a number of years. Total market sales for all forms of Metformin were $1.6 billion (IMS - MAT: June 2003).
Riomet will be marketed and distributed by the Brand Products Division (B.P.D.) of Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy. RPI 's BPD has been created with the specific mission of marketing brand name products that will materialize through the Ranbaxy pipeline in the years to come. B.P.D. will promote Riomet to prescribers and the product will be available through wholesalers, distributors and pharmacies on a nationwide basis as inventories are created to support market demands, the statement said.
According to Dipak Chattaraj, President of RPI, "With this new dosage form, Ranbaxy is adding clinical utility and value to a well-established and accepted molecule that is employed in the management of patients with diabetes. This 'value-added' product offering is intended to provide utility and prescribing flexibility to both patients and prescribers. We strongly believe that this dosage form demonstrates Ranbaxy's commitment and measurable contribution to the U.S. healthcare system."
Based in Princeton, New Jersey, RPI is a wholly owned subsidiary of RLL, India having established operations in the U.S. in 1994 and launching its first prescription product in January 1998, following FDA approval in August 1997. For the year 2002, U.S. operations achieved sales of U.S. $ 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. RPI markets a basket of generic products covering major therapeutic areas. In 2002, RPI was ranked as the 9th largest in the U.S. generics market.