The US Food and Drug Administration says that a facility owned by India's leading drugmaker Ranbaxy Laboratories, which has recently become majority-owned by Japan's Daiichi Sankyo (Marketletters passim), 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, and the agency is continuing to investigate this matter to ensure the safety and efficacy of marketed drugs associated with this Ranbaxy site. Last year, the agency issued two warning letters and an import alert relating to pharmaceuticals produced at the company's Dewas and Paonta Sahib plants, effectively barring around 30 generics from the US market (Marketletter September 22, 2008).
To date, the FDA says it has no evidence that these drugs do not meet their quality specifications and has not identified any health risks associated with the firm's currently-marketed products.
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