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Chemical Week Magazine :: Pharmaceuticals & Fine Chemicals

FDA Charges Ranbaxy with Falsifying Data at India Plant

11:11 AM MST | March 6, 2009 | DEEPTI RAMESH

The U.S. FDA has charged Ranbaxy Laboratories (Gurgaon, India) with falsifying data and test results in approved and pending drug applications at the company’s Paonta Sahib, India facility. The agency says it has stopped reviewing new or pending drug approval applications from the plant, which has been under an FDA import alert since last September for deviating from U.S. cGMP (CW, Sept. 22, 2008, p. 4). Ranbaxy says it will co-operate with FDA. Woodcock: ‘Companies must provide truthful and accurate information.’ Applications that are affected...

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