Navigation Links
Ranbaxy Receives Final Approval to Manufacture and Market Glycopyrrolate Tablets

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.

"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 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, 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(R) is a registered trademark of Sciele Pharma, Inc.

    CONTACTS:  Charles M. Caprariello
               Vice President, Corporate Communications
               Ranbaxy Inc.
               (609) 720-5615

               Edwige Buteau
               RF Binder Partners Inc.
               (212) 994-7517

               Andrea Pavone
               RF Binder Partners Inc.
               (212) 994-7568

SOURCE Ranbaxy Pharmaceuticals Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Ranbaxy Receives Tentative Approval to Manufacture and Market Galantamine Tablets on an Exclusive Basis
2. Ranbaxy Gains Approval to Manufacture and Market Carvedilol Tablets in the U.S. Market
3. Ranbaxy First to Gain Approval to Manufacture and Market Clarithromycin for Oral Suspension, USP
4. Ranbaxy Receives Tentative Approval For Valsartan Tablets
5. Ranbaxy Receives Final Approval to Manufacture and Market Cetirizine Hydrochloride Tablets (OTC), 5mg and 10mg
6. Ranbaxy Gains Approval to Manufacture and Market Cefuroxime Axetil for Oral Suspension
7. Ranbaxy Receives Final Approval to Manufacture and Market Cetirizine Hydrochloride Oral Solution
8. Ranbaxy to Bring in Daiichi Sankyo as Majority Partner; Strategic Combination Creates Innovator and Generic Pharma Powerhouse
9. Ranbaxy and Pfizer Settle Lipitor Litigation Worldwide
10. Cipher Pharmaceuticals announces U.S. distribution and supply agreement with Ranbaxy for CIP-ISOTRETINOIN
11. Press Statement Issued by Ranbaxy Laboratories Limited
Post Your Comments:
(Date:11/30/2015)... ... November 30, 2015 , ... ... four states in the U.S. require dental technicians to be certified or obtain ... industry, NADL created the “What’s In Your Mouth?” campaign to inform dentists that ...
(Date:11/30/2015)... MN (PRWEB) , ... November 30, 2015 , ... ... at . The directory is specialized and only includes chiropractic clinics ... to find a competent and trustworthy alternative health practitioner when back pain sets ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... experience this summer, ushering in a new era of publicly accessible automated technology. ... shuttle, will continue to offer guests an up-close look at the shuttle at ...
(Date:11/30/2015)... (PRWEB) , ... November 30, 2015 , ... ... and fun atmosphere for Halloween festivities, the Word of Life Christian Church of ... board game, and featuring a giant 1.25 ton pile of candy dubbed “Candy ...
(Date:11/30/2015)... (PRWEB) , ... November 30, 2015 , ... ... community across the United States to access life-saving information provided directly ... Mesothelioma will consist of three individual conferences in three major cities: Houston, ...
Breaking Medicine News(10 mins):
(Date:11/30/2015)... Die MEDTEC Japan 2016, ... Entwicklung und Herstellung medizinischer Geräte, findet ... in Tokyo ... Foto: ... --> ...
(Date:11/30/2015)... SINGAPORE , Nov. 30, 2015  QT Vascular ... Vascular", and together with its subsidiaries, TriReme Medical LLC ... global company engaged in the design, assembly and distribution ... of vascular disease, is pleased to announce that a ... Court of Appeals for the Federal Circuit ("Federal ...
(Date:11/30/2015)... 30, 2015 Diplomat Pharmacy, Inc. (NYSE: ... the Detroit Free Press as a Top Workplace , ... to work for in 2015. ... 100 winners annually, based on employee surveys rating company leadership, ... Workplaces are based solely on employee feedback. The survey is ...
Breaking Medicine Technology: