PRINCETON, N.J., June 30 /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 Cefprozil for Oral Suspension USP,
125 mg/5mL and 250 mg/5mL. 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
Cefzil(R)* for Oral Suspension by Bristol Myers Squibb Company
Pharmaceutical Research Institute. Total annual market sales for Cefprozil
were $93 million (IMS - MAT: March 2006).
Cefprozil Suspension is indicated for the treatment of patients with
mild to moderate infections caused by susceptible strains of the designated
microorganisms in the conditions listed: Pharyngitis/tonsillitis, Otitis
Media, Acute Sinusitis, secondary bacterial infection of Acute Bronchitis
and Acute Bacterial Exacerbation of Chronic Bronchitis and uncomplicated
skin and skin-structure infections.
"Ranbaxy is pleased to market this product as an addition to our ever
growing product portfolio of anti-infectives that will be available as an
affordable generic to the brand. This formulation will be produced in our
cGMP compliant, cephalosporin dedicated facility in Dewas, India. Our plans
are to bring this product to the market immediately," according to Jim
Meehan, Vice President of Sales and Marketing 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 8 countries.
* Cefzil(R) is a registered trademark of by Bristol Myers Squibb
Company Pharmaceutical Research Institute
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.
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Related links:
http://www.ranbaxy.com
CONTACT:
Charles M. Caprariello, Vice President,
Corporate Communications of Ranbaxy Inc., +1-609-720-5615; or
Edwige Buteau, +1-212-994- 7517, or Anuj Baveja, +1-212-994-7552,
both of RF Binder Partners Inc.
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