Navigation Links
Ranbaxy Gains Approval to Manufacture and Market Carvedilol Tablets in the U.S. Market


PRINCETON, N.J., Sept. 6 /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 Carvedilol Tablets, 3.125 mg, 6.25 mg, 12.5, and 25 mg, a beta blocker used to treat heart failure. 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 Coreg(R) Tablets, 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg, respectively, of GlaxoSmithKline. Total annual market sales for Carvedilol Tablets were $1.6 billion (IMS - MAT: June 2007).

Carvedilol is indicated for the treatment of mild-to-severe heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitor and digitalis. Carvedilol is also indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction, as well as in the management of essential hypertension, alone or in combination with other antihypertensive agents.

"We are pleased to receive this FDA approval for Carvedilol Tablets that will add depth and breadth to our product line of medications used in cardiovascular diseases. This approval further represents yet another approval in 2007, that expands our product portfolio of affordable generic alternatives. Carvedilol will be manufactured at our Ohm Laboratories facility in New Brunswick, New Jersey and launched in to all classes of trade early in the fourth quarter of 2007 under the RPI label," noted 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.

* Coreg(R) is a registered trademark of GlaxoSmithKline.

CONTACTS: Charles M. Caprariello

Vice President, Corporate Communications

Ranbaxy Inc.

(609) 720-5615

Edwige Buteau

RF Binder Partners Inc.

(212) 994-7517

Anuj Baveja

RF Binder Partners Inc.

(212) 994-7552

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. Ranbaxy Gets USFDA Approval For Doxycycline Tablets
11. SRL Ranbaxy offers quicker bird flu diagnostic test
Post Your Comments:
(Date:11/27/2015)... ... November 28, 2015 , ... There is only one major question ... from last year? , This question has not been an easy question to answer. ... retirement age and the younger workforce don’t share the same discipline around working long ...
(Date:11/27/2015)... ... November 27, 2015 , ... The rapid speed at which ... age, more care is needed, especially with Alzheimer’s, dementia and other cognitive conditions ... overworked. The forgotten part of this equation: 80 percent of medical care occurs ...
(Date:11/27/2015)... , ... November 27, 2015 , ... Lizzie’s Lice Pickers ... company is offering customers 10% off of their purchase of lice treatment product. In ... full price. According to a company spokesperson. “Finding lice is a sure way to ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... through sharing, the 2016 Building Better Radiology Marketing Programs meeting will ... on Sunday, March 6, 2016, at Caesars Palace in Las Vegas with a ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... innovative online platform for mental health and wellness consultation, has collaborated with a ... will bridge the knowledge gap experienced by parents and bring advice from parenting ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... 2015 ... the  "2016 Future Horizons and Growth ... Testing Market: Supplier Shares, Competitive Intelligence, ... --> ) has ... Future Horizons and Growth Strategies in ...
(Date:11/26/2015)... PUNE, India , November 26, ... --> --> ... Research Report" and "Investigation Report on ... 2019 and 2021 forecasts data and ... library. . ...
(Date:11/25/2015)... 25, 2015 ... the "Global Brain Monitoring Devices Market ... --> ) has announced the ... Devices Market 2015-2019" report to their ... ( ) has announced the addition ...
Breaking Medicine Technology: