Navigation Links
Ranbaxy Receives Final Approval to Manufacture and Market Glycopyrrolate Tablets
Date:8/24/2009

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:
*Name:
*Comment:
*Email:
(Date:3/1/2017)... ... ... Financial Recovery Group, Inc. (FRG), is proud to announce it will participate ... company also is offering a special discount for those who attend the event as ... the brightest minds in the healthcare industry to share information on risk adjustment, quality ...
(Date:3/1/2017)... , ... March 01, 2017 , ... The Industrial Designers ... 5, 2017 by raising awareness of the profession of industrial design (ID) and relaunching ... content geared toward high school students and counselors; parents; and the greater public. , ...
(Date:3/1/2017)... ... March 01, 2017 , ... ... embedded anti-odor solution to cotton knit and woven fabrics. , Retail brands ... the luxurious look and feel of cotton. Cotton Incorporated has developed cotton-rich ...
(Date:3/1/2017)... ... March 01, 2017 , ... On January 27, 2017, Laffey, Bucci & Kent ... abuse lawsuit in the Circuit Court of Kanawha County, West Virginia. The lawsuit was ... their initials. See L.B. and T.B. v. Seventh-Day Adventist Church et al. Case #: ...
(Date:3/1/2017)... ... March 01, 2017 , ... Grund® America is proud to ... launching at the March 2017 International Housewares Show in Chicago (Grund Booth N6466). , ... with the highest quality,100% OEKO-TEX and GOTS Organic Cotton material. By adding the ...
Breaking Medicine News(10 mins):
(Date:3/1/2017)... SAN FRANCISCO , March 1, 2017 The global  ... based on a new report by Grand View Research, Inc. The intraoperative neuromonitoring ... be attributed to the hospitals adopting intraoperative monitoring in a wide spectrum of ... ... Grand View Research Logo ...
(Date:3/1/2017)... , Italia, March 1, 2017 El mismo sistema se mostrará ... Continue Reading ... The open MRI scanner - MROpen ... ... MROpen en el Reino Unido y la primera en Gales. El escáner se localizará en ...
(Date:2/28/2017)... , Feb. 28, 2017 Mechanical Ventilators ... full report: https://www.reportbuyer.com/product/4402626/ This report ... on the global and regional levels. It provides historical ... 2024 in terms of revenue (US$ Mn) and volume ... an outlook on mechanical ventilators sales globally. It includes ...
Breaking Medicine Technology: