Ranbaxy Laboratories Limited (RLL), announced today, that the Company 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® 1 mg and Robinul® Forte Tablets, 2 mg, respectively, of Sciele Pharma, Inc. The 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.
“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 U.S. healthcare system,” according to Jim Meehan, Vice President of Sales and Distribution for RPI.
Ranbaxy Pharmaceuticals Inc. (RPI), based in Jacksonville, Florida, USA, 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.
Ranbaxy Laboratories Limited, headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary "platform technologies", resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries. Ranbaxy Laboratories Limited is a subsidiary of Daiichi Sankyo Company, Limited.
Source: Ranbaxy
