Ranbaxy Labs responds to FDA action against Paonta Sahib plant

2/25/2009

GURGAON, India Ranbaxy Labs issued a statement Wednesday afternoon in response to action that the Food and Drug Administration had taken against the company's plant in Paonta Sahib, India.

The FDA invoked an Application Integrity Policy after finding falsified data and test results on regulatory approval applications from the plant, though the agency has found no evidence that Ranbaxy drugs on the market are substandard, and the policy does not affect the company's other plants. The plant has been under an FDA import alert since September.

Ranbaxy said it will analyze the letter and other information and respond appropriately, and that it is continuing to cooperate with the FDA.

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