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:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... agency serving communities in the greater Dallas, Miami, and Raleigh regions, is organizing ... fighting to overcome a rare and deadly chromosome abnormality. , After struggling since ...
(Date:10/13/2017)... ... October 13, 2017 , ... While it’s often important to ... Fortunately, an inventor from Austin, Texas, has identified a solution. , She developed a ... or restricted lighting. As such, it eliminates the need to turn on a light ...
(Date:10/13/2017)... Nevada (PRWEB) , ... October 13, 2017 , ... ... Hemp CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil ... required and providing a CBD form that can be easily incorporated into liquid products, ...
(Date:10/13/2017)... ... ... Apple Rehab Shelton Lakes , which specializes in the delivery of sub-acute ... of a disaster drill on October 3rd. , Apple Rehab participated with the Shelton ... well as the Connecticut Long Term Care Mutual Aid Plan (LTC-MAP). The LTC-MAP ...
(Date:10/13/2017)... NY (PRWEB) , ... October 13, 2017 , ... Ellevate ... people in business to advocate for action towards gender equality at their inaugural Summit ... from around the globe, and reached a social audience of over 3 million. To ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... 2, 2017  AllianceRx Walgreens Prime, the combined central ... and pharmacy benefit manager Prime Therapeutics LLC (Prime), today ... included the unveiling of new signage at its headquarters ... as at a few other company-owned facilities across the ... patients, some of whom will begin to see the ...
(Date:9/28/2017)... WASHINGTON , Sept. 28, 2017 Cohen ... to advance the use of wearable and home sensors ... brain disorders. Early Signal Foundation, a nonprofit organization focused ... populations, will provide an affordable analytical system to record ... ...
(Date:9/25/2017)... 2017  EpiVax, Inc., a leader in the ... today announced the launch of EpiVax Oncology Inc., ... therapeutic cancer vaccines. EpiVax has provided $500,000 in ... enabling technologies to the new precision immunotherapy venture. ... Oncology as Chief Executive Officer. Gad brings over ...
Breaking Medicine Technology: