Navigation Links
Ranbaxy First to Gain Approval to Manufacture and Market Clarithromycin for Oral Suspension, USP
Date:10/2/2007

Ranbaxy One of Few Companies to Offer Both Suspension and Tablet Forms

PRINCETON, N.J., Oct. 2 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received final approval from the U.S. Food and Drug Administration (U.S. FDA) to manufacture and market Clarithromycin for Oral Suspension, USP, 125 mg/5 mL and 250 mg/5 mL. Ranbaxy is the first company to have been granted a generic approval for the Oral Suspension form along with Clarithromycin Tablets. Total annual market sales for Clarithromycin were $99.7 million with suspension sales totaling $25.3 million (IMS - MAT: June 2007).

"We are pleased to receive this FDA approval for Clarithromycin for Oral Suspension, an anti-infective agent that will add depth and breadth to our product line of anti-infectives that also includes Clarithromycin tablets. RPI will be in a position to offer both dosage forms for this molecule that will distinguish Ranbaxy in the market place. This approval further expands our product portfolio of affordable generic alternatives and will be shipped immediately to all classes of trade," according to Jim Meehan, Vice President of Sales and Distribution for RPI.

The Office of Generic Drugs, U.S. FDA, determined the Ranbaxy formulation to be bioequivalent and to have the same therapeutic effect as that of the reference listed drug Biaxin(R) Granules (Clarithromycin for Oral Suspension, USP), 125 mg/5 mL and 250 mg/5 mL of Abbott Laboratories.

Clarithromycin for oral suspension, USP, is indicated for the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in a number of conditions including: Pharyngitis/Tonsillitis, Community-Acquired Pneumonia, uncomplicated skin and skin structure infections and disseminated mycobacterial infections.

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, India's largest pharmaceutical company, 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.

CONTACTS:

Charles M. Caprariello Edwige Buteau

Vice President, Corporate Communications RF Binder Partners Inc.

Ranbaxy Inc. (212) 994-7517

(609) 720-5615

Anuj Baveja

RF Binder Partners Inc.

(212) 994-7552

*Biaxin(R) Granules (Clarithromycin for Oral Suspension, USP) is a registered trademark of Abbott Laboratories


'/>"/>
SOURCE Ranbaxy Pharmaceuticals Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. RANBAXY - enters anti-AIDS segment
2. Ranbaxy joins hand with Cipla to co-market ciprofloxacin
3. Ranbaxy gets US FDA approval for Lisinopril
4. Ranbaxy Labs Entry Into Anti-Acne Market
5. Ranbaxy trying to make inroads in herbal drugs market
6. Lamivudine Manufactured By Ranbaxy gets the nod from the US FDA
7. Ranbaxy Pharmaceuticals Inc awarded the prestigious outstanding supplier award received from Wal-Mart
8. Ranbaxy opens Drug discovery centre in Gurgaon
9. Ranbaxy Laboratories All Set To Export Bird Flu Vaccines
10. SRL Ranbaxy offers quicker bird flu diagnostic test
11. Diagnostic Test Launched by Ranbaxy for En Masse Screening of Bird Flu
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/24/2017)... ... March 24, 2017 , ... ... related services to families and business owners across eastern Michigan, is connecting with ... families struggling with financial difficulties. , The Oxford/Orion FISH Food Pantry works to ...
(Date:3/24/2017)... ... March 24, 2017 , ... Northridge ... now offering treatments for sleep apnea and TMJ at their office. TMJ, or ... , specifically the obstructive type, is increasingly being treated at dental offices with ...
(Date:3/24/2017)... ... March 24, 2017 , ... Gastro Health (“GH”) ... prep patients for colonoscopy at the HyGIeaCare® Center that is to be located ... , The HyGIeaCare® Prep, cleared by the U.S. Food and Drug ...
(Date:3/24/2017)... , ... March 24, 2017 , ... “End Time GPS”: ... salient events will interrelate. “End Time GPS” is the creation of published author, ... expert while working on military munitions and space-vehicle projects. Now, at age ninety-one, he ...
(Date:3/23/2017)... , ... March 23, 2017 , ... In 2016 the ... estimates that there could be four million Zika-related cases in the Americas within the ... numbers of US cases reported per year skyrocketing to an estimated 329,000. Yet, Zika, ...
Breaking Medicine News(10 mins):
(Date:3/24/2017)... YORK , March 24, 2017   ... leading organization within medical affairs in the pharmaceutical ... as the chair of a newly formed scientific ... board members to form the first ever medical ... For more information about the ACMA, please ...
(Date:3/24/2017)... -- Research and Markets has announced the addition of the ... their offering. ... pipeline is very strong with a total of 97 drug candidates. Pharma ... Sanofi are involved in the development of the IPF therapeutics. The IPF ... III stage, 15 are in Phase II stage, 12 are in Phase ...
(Date:3/24/2017)... Today Stock-Callers.com have issued research reports ... Inc. (NASDAQ: NVCN), Hologic Inc. (NASDAQ: HOLX), Edwards Lifesciences Corp. ... ). These companies are part of the Healthcare sector, which ... 23 rd , 2017, with the NYSE Health Care Index ... companies in the S&P 500 were down about 0.4% as ...
Breaking Medicine Technology: