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Wockhardt Barred From Making Drugs for Europe


7/10/2013 7:41:07 AM

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Wockhardt Ltd. (WPL), an Indian maker of insulin and hepatitis vaccines, was barred from making drugs for Europe after its Waluj factory failed to meet some guidelines from the U.K. regulator. The U.K.’s Medicines and Healthcare Products Regulatory Agency is working with Wockhardt, the U.S. Food and Drug Administration and other international regulators to help resolve the issues so production can resume, the U.K. agency said in an e-mail yesterday. The statement of non-compliance for the plant covers medicines to Europe and the U.K., it said. The ban adds to restrictions on exports by Wockhardt after U.S. regulators in May barred drugs from the same factory, a move that Chairman Habil Khorakiwala said would cut about $100 million from the company’s revenue in the year started April 1.

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