Healthcare Industry News:  amlodipine 

Biopharmaceuticals Generics FDA

 News Release - July 10, 2007

Ranbaxy Receives Final Approval To Manufacture and Market Amlodipine Besylate Tablets

PRINCETON, N.J., July 10 (HSMN NewsFeed) -- 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 to manufacture and market amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base). 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 Norvasc TabletsŪ of Pfizer Pharmaceuticals Inc. Total annual market sales for NorvascŪ, amlodipine Besylate Tablets were $2.79 billion (IMS - MAT: March 2007).

amlodipine Besylate Tablets are indicated for the treatment of hypertension and may be used alone or in combination with other antihypertensive agents. amlodipine Besylate is also indicated for the symptomatic treatment of chronic stable angina and may be used alone or in combination with other antianginal agents. amlodipine Besylate Tablets are also indicated for the treatment of confirmed or suspected vasospastic angina and may be used as monotherapy or in combination with other antianginal drugs.

"We are pleased to receive this final FDA approval for amlodipine Besylate Tablets, which represents Ranbaxy's 115th ANDA approval to date. This product will further expand our product portfolio of affordable generic alternatives and will be launched in August 2007 to all classes of trade," said 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 indeveloped 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.

*NorvascŪ is a registered trademark of Pfizer Pharmaceuticals Inc.


Source: Ranbaxy Pharmaceuticals

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