Ipca - Ranbaxy alliance receive US FDA marketing approval for Atenolol Tablets

Ipca Laboratories Ltd had earlier announced strategic alliance with Ranbaxy Pharmaceuticals Inc (Ranbaxy) based in Jacksonville, Florida (USA), a wholly owned subsidiary of Ranbaxy Laboratories Ltd, India's largest pharmaceutical company.

Under the strategic alliance, Ranbaxy has now received approval from U.S. Food and Drugs Administration to manufacture and market Atenolol Tablets USP 25mg, 50mg and 100mg in the US market. Total annual market sales for Atenolol tablets in U.S. were US $133.6 million (IMS-MAT: September 2006).

Initially, Ranbaxy will manufacture and market this formulation in the US healthcare system from first quarter 2007 using the Company's DMF approved Active Pharmaceutical Ingredient (API) - Atenolol. In future, the Company will manufacture this formulation utilizing its facilities in India. The Company is setting up a new formulations manufacturing facility meeting U.S. regulatory requirements at SEZ Indore with an initial capital outlay of approximately Rs 60 crores.

anbaxy will commercialise this product in the U.S. market utilizing its established marketing expertise and distribution network.

The Company is one of the largest producer in the world of API Atenolol and holds its DMFs in various countries. The Company is also marketing formulations of Atenolol in various markets such as CIS, Asia, Africa and Europe. This approval will further strengthen the Company's global market share of this product.

This is the second such product approval received under the alliance from U.S. FDA after Furosemide tablets which was approved in September 2006.

Source : Equity Bulls

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