Ranbaxy Laboratories Limited (RLL), has received approval from the US Food and Drug Administration (US FDA) to manufacture and market glycopyrrolate tablets USP, 1 mg and 2 mg. The Office of Generic Drugs, US FDA, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Robinul 1 mg and Robinul Forte tablets, 2 mg, respectively, of Sciele Pharma, Inc.

The total annual market sales for glycopyrrolate tablets were $26 million. glycopyrrolate tablets are indicated for use as adjunctive therapy in the treatment of peptic ulcer.

"We are pleased to receive this final approval for glycopyrrolate tablets. The product formulation will be launched in the October- December quarter to all classes of trade and further expands the number of affordable generic product formulations offered by RPI, that will be of benefit to patients, healthcare professionals and the US healthcare system," according to Jim Meehan, vice president of sales and distribution for RPI.