labels: pharmaceuticals, ranbaxy, ipca laboratories
Ipca - Ranbaxy alliance receive US FDA marketing approval for atenolol tabletsnews
02 January 2007

Ranbaxy Laboratories Ltd has received approval from the US Food and Drug Administration (FDA) to manufacture and market Atenolol Tablets USP 25 mg, 50 mg, and 100 mg. The office of Generic Drugs, US Food and Drug Administration, has determined the Company's formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Tenormin of Astra Zeneca LP.

Atenolol is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.

Atenolol is also indicated for the long-term management of patients with angina pectoris due to coronary atherosclerosis and is also indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce, cardiovascular mortality.

Jackson- (Florida) based Ranbaxy Pharmaceuticals Inc, wholly owned US subsidiary of Ranbaxy Laboratories and Ipca Laboratories Ltd had entered into a strategic alliance under which Ranbaxy would initially manufacture and market this formulation in the US healthcare system from first quarter 2007 using Ipca's DMF approved active pharmaceutical ingredient (API) atenolol.

Later, Ipca will manufacture this formulation at its facilities in India for which Ipca is setting up a new formulations manufacturing facility meeting US regulatory requirements at the SEZ at Indore. This plant will have an initial capital outlay of approximately Rs60 crore.

Ranbaxy will commercialise this product in the US market utilising its marketing expertise and distribution network.

According to Jim Mechan, vice president, sales and marketing for the RPI, USA.

"This approval is the result of a strategic alliance with Ipca Laboratories Ltd of Mumbai, India who will develop a number of generic prescription pharmaceutical products which will be marketed by RPI in the US in the future following US FDA approval. RPI labeled Atenolol tablets will be made available to our customers in the US healthcare system during first quarter 2007."

Ipca is one of the largest producers of API atenolol in the world and holds its DMFs in various countries. The company is also markets formulations of atenolol in various countries such as CIS, Asia, Africa and Europe.

This is the second such product approval received under the Ipca - Ranbaxy alliance from US FDA after furosemide tablets which was approved in September 2006.

also see : Ipca Laboratories in marketing alliance with Ranbaxy for US sales

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Ipca - Ranbaxy alliance receive US FDA marketing approval for atenolol tablets