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Ranbaxy laboratories

The Punjab-based drug maker reached a settlement with the US drug regulator while setting aside US$500 million to address its potential liability from a separate US Justice Department investigation. The new consent decree with the US Food and Drug Administration (FDA), which is subject to approval by the US District Court in Maryland. comes after the regulator banned the company in 2008 froni importing more than 30 of its generic dms because of violations of manufacturing practices at two plaits, at Dewas in central India and Paonta Sahib in northern India. The FDA also halted review of drug applications from Paonta Sahib in 2009, alleging Ranbaxy had falsified data. The agreement with the FDA would strengthen its procedures on data integrity and comply with current good manufacturing practices. The generic drug maker also said its new US$500 million reserve would cover all potential civil and criminal liability.