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      Indian drug firms fear Chinese generics in US

      Posted AtReuters

      KUALA LUMPUR (Reuters) - Indian generic drug firms may have made it big in the United States, but their advantage could fade if China enters the market with its own cheap copies of drugs, India's top drug maker Ranbaxy said on Tuesday.

      After years of steady growth, Bombay-listed Ranbaxy Laboratories Ltd saw a sharp drop in net profit for the first two quarters of 2005 due to competition in the U.S. generic drugs industry, among others.

      But with China expected to seek U.S. Food and Drug Administration approval for its first generic drug by next year, the market could become flooded with even cheaper clones in the next five years, said Brian Tempest, chief executive of Ranbaxy.

      "I do believe that the Chinese pharmaceutical companies will come to U.S.A," Tempest told Reuters. "There's not one that's filed yet, but I think it will happen shortly."

      "That will add to the pricing pressure," he said in Malaysia ahead of the opening of a new Ranbaxy plant.

      Tempest said Ranbaxy had 102 product approvals from the F.D.A. and was awaiting approval for 50 more.

      The recent acquisition of Israel's Ivax Corp by Teva Pharmaceuticals Industries also means Ranbaxy will have the second-largest pipeline of filings with the F.D.A.

      Product filings basically determine the worth of a generic drug company.

      Ranbaxy had sales of approximately $420 million in the United States last year and is eyeing a bigger share of a market worth more than $30 billion as more drugs' patent protections expire.

      Already, the emergence of more competitors in the U.S. market this year has caused prices of generic drugs to fall, hurting Ranbaxy.

      Tempest said even greater competition for his company and Indian drug makers such as Dr. Reddy's Laboratories Ltd, another early entrant in the U.S. market, would be Chinese firms with similar or possibly lower priced drugs than their Indian rivals.

      "It took Ranbaxy five to six years to get to its place of significance in the U.S. market. I think it will probably take the Chinese a similar sort of period," he said.

      "The world will then see Chinese pharmaceutical companies doing filings in the U.S.A. and Europe at a level which you don't see today."

      He said the Chinese drug business, although fledgling, was already established for its source of raw materials, known in the industry as Active Pharmaceutical Ingredients or API.

      "Ranbaxy itself buys a certain amount of its API from China. You buy the cheapest API you can for the specifications, quality and the regulatory approval you need."

      "China's already got U.S. approval for the raw materials and the plants to make them. But in terms of turning that API into capsules, that's the step they are not at yet."

      Ultimately, what would help Indian drug makers in the United States is a competitive advantage not far from China's and a proven business record of more than 30 years.

      "I do believe that the competitive advantage of India is well accepted by all the generic companies around the world and the big pharma companies."

      He said Sandoz, the copycat drug maker owned by Switzerland's Novartis AG and Teva, were expanding research in India, while GlaxoSmithKline Plc and Pfizer were doing more clinical studies there.

      U.S.-based Merck & Co. and Bristol-Myers Squibb Co. had also returned to India after pulling out years ago.

      "I think it's important to take advantage of the strength of the Indian venture chemist and the Indian biologist in order to deliver a stronger product flow. If we get the product flow right, then the return to shareholders would follow."

      August 02, 2005


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