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January 02, 2007 14:09 IST
Ranbaxy Pharmaceuticals Inc said on Tuesday it has received US Food and Drug Administration's approval for manufacturing and marketing cardiovascular drug -- Atenolol tablets in the US.
"We are pleased to receive this final FDA approval to market Atenolol tablets. This will further expand our product portfolio of affordable generic alternatives to the brand in the treatment of cardiovascular disorders," Ranbaxy Pharmaceuticals Inc Vice President of Sales and Marketing division (US) Jim Mechan said.
This approval is the result of a strategic alliance with Ipca Laboratories, Jim Mechan added.
Ipca Laboratories had earlier announced strategic alliance with US-based Ranbaxy Pharmaceuticals Inc, a wholly owned subsidiary of Ranbaxy Laboratories.
Initially, Ranbaxy would manufacture and market Atenolol tablets in 25 mg, 50 mg and 100 mg in the US market from first quarter this year. In future, Ipca would manufacture this formulation utilising its facilities in India.
Ranbaxy would commercialise this product in the US market utilising its established marketing expertise and distribution network.
Charting out future plans, Ipca said it is also setting up a new formulations manufacturing facility meeting US regulatory requirements at its Special Economic Zone at Indore with an initial capital outlay of around Rs 60 crore (Rs 600 million).
Ipca, one of the largest producer in the world of Active Pharmaceuticals Ingredients Atenolol, holds its Drug Master filed in various countries.
This is the second such product approval received under the alliance from USFDA after Furosemide tablets, which was approved in September 2006. Do you want to discuss stock tips? Do you know a hot one? Join the Stock Market Discussion Group.
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