This from The Guardian online (http://business.guardian.co.uk/story/0,,2014598,00.html):
US regulator raids offices of copycat drug firm
[FONT=Geneva,Arial,sans-serif]Andrew Clark in New York
Friday February 16, 2007
America's healthcare regulator has raided the premises of Ranbaxy, the Indian specialist in "copycat" drugs which has been snapping at the heels of global pharmaceutical companies by challenging their right to exclusive patents. Officials from the Food and Drug Administration searched Ranbaxy's US headquarters in Princeton, New Jersey, and the company's manufacturing site at nearby New Brunswick.
The visits, which took place on Tuesday, were revealed by Ranbaxy in a statement yesterday which said: "This action has come as a surprise. The company is not aware of any wrongdoing. It is cooperating fully with the officials."
A week ago, Ranbaxy won legal permission to launch a generic competitor to Pfizer's antidepressant Zoloft. It also makes a version of Prozac and aims to make the first competitor to the world's best selling drug, the anti-cholesterol product Lipitor, which goes off patent in 2010.
The FDA's interest is likely to send shockwaves through the generic drugs industry, although it was unclear whether the agency was investigating copyright, pricing, quality or other issues.
A Ranbaxy spokesman said the company's general counsel was seeking more information about the reason for the raids. "We're trying to get to the bottom of it. There was a request for information, but it was a very broad request." The FDA did not respond to requests for comment yesterday.
Ranbaxy generates sales of some $426m in the US, but has said it wants to raise this to $5bn by 2012. It has 47 products on the market in America, 40% of them made in New Brunswick.
It leads the world in making generic drugs which undercut established pharmaceutical companies as soon as the patents on popular products lapse. It has developed an expertise in challenging patent extensions to drugs. It has been widely praised in developing countries for making medicines more affordable. But it has often infuriated the pharmaceutical establishment. Earlier this month, Glaxo sought an injunction to stop Ranbaxy selling a generic version of Valtrex, a treatment for shingles and herpes, in the US.
Ranbaxy has grown rapidly to become a sprawling multinational; it manufactures in nine countries and sells products to customers in 125 states. In Britain, it was charged last year with price fixing by the Serious Fraud Office, which is investigating an alleged cartel controlling the supply of penicillin-based antibiotics. Until recently, Ranbaxy was run by a Lancashire-born scientist, Brian Tempest. He stood back to become vice-president last year, making way for Malvinder Singh, the grandson of its founder, to become managing director.
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