RANBAXY RECEIVES FINAL APPROVAL
TO MANUFACTURE AND MARKET GLYCOPYRROLATE TABLETS
Princeton, NJ – August 24, 2009
-- 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® 1 mg and Robinul® 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.
“We are pleased to receive this final approval
for Glycopyrrolate Tablets. This product formulation
will be launched in the October – December quarter
to all classes of trade and further expands the number
of affordable generic product formulation 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, 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 is a subsidiary
of Daiichi Sankyo Company, Ltd.
*Robinul® is a registered trademark of Sciele
Pharma, Inc.
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