US FDA says Ranbaxy falsified data

9 March 2009

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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