The U.S. Food and Drug Administration has prohibited Ranbaxy Laboratories Ltd., India’s largest drug manufacturer, from introducing new generic drugs from one of its factories after it falsified data about products’ shelf life.
Yesterday, the FDA announced that a facility owned by Ranbaxy Laboratories falsified data and test results in approved and pending drug applications. The facility, Paonta Sahib, has been under an FDA Import Alert since September 2008.
The FDA announced that it was continuing to investigate this matter to ensure the safety and efficacy of marketed drugs associated with Ranbaxy’s Paonta Sahib site. To date, the FDA has no evidence that these drugs do not meet their quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products.
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