PRINCETON, N.J., Aug. 24 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received approval from the U.S. Food and Drug Administration to manufacture and market Glycopyrrolate Tablets USP, 1 mg and 2 mg. The Office of Generic Drugs, U.S. 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 Robinul(R) 1 mg and Robinul(R) Forte Tablets, 2 mg, respectively, of Sciele Pharma, Inc. Total annual market sales for Glycopyrrolate Tablets were $26 million (IMS - MAT: June 2009). Glycopyrrolate Tablets are indicated for use as adjunctive therapy in the treatment of peptic ulcer.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India’s largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.
*Robinul(R) is a registered trademark of Sciele Pharma, Inc.
SOURCE Ranbaxy Pharmaceuticals Inc.
CONTACT: Charles M. Caprariello, Vice President, Corporate Communications
of Ranbaxy Inc., +1-609-720-5615; or Edwige Buteau, +1-212-994-7517, or
Andrea Pavone, +1-212-994-7568, both of RF Binder Partners Inc.
