Ranbaxy Laboratories has received approval from the US Food and Drug Administration (FDA) to manufacture and market Glycopyrrolate Tablets USP, 1mg and 2mg. The Ranbaxy formulations is bioequivalent and have the same therapeutic effect as that of the drug – Robinul 1mg and Robinul Forte tablets 2mg, respectively, of Sciele Pharma.
Glycopyrrolate tablets are indicated for use as an adjunctive therapy in the treatment of peptic ulcer.
Jim Meehan, vice president of sales and distribution for Ranbaxy Pharmaceuticals, said: We are pleased to receive this final approval for Glycopyrrolate Tablets. The product formulation will be launched in the Oct – Dec 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.