Company has pleaded guilty to fabricating data and producing substandard drugs
A long-running investigation by the US Department of Justice (DOJ) and Food and Drugs Administration (FDA) has ended with a $500 million (£330 million) fine for generic drugmaker Ranbaxy. The company admitted serious systemic failings in its manufacturing methods, as well as fabricating data to support applications for regulatory approval. This resulted in the company knowingly selling substandard drugs.
The case was initiated in 2007, when Dinesh Thakur, a former Ranbaxy executive, blew the whistle on the company’s activities. Thakur will receive $48.6 million from the federal share of the fine under US whistleblower law.
The company insists that the problems have now been resolved and that its products are safe. However, its parent company, Daiichi Sankyo of Japan, believes that ‘certain former shareholders of Ranbaxy concealed and misrepresented critical information concerning the DOJ and FDA investigations’, it said in a statement. Daiichi is currently considering its available legal actions.
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