Ranbaxy pharmaceuticals news
Ranbaxy said it expects to produce within a month all documents requested by the U.S. Department of Justice in an ongoing investigation into the company’s alleged introduction of adulterated and misbranded products into interstate commerce. The DoJ filed a motion earlier this month in the U.S. District Court for the District of Maryland to enforce the subpoenas for information related to a third-party audit of Ranbaxy’s Paonta Sahib facility. In 2006, FDA imposed a compliance hold on approval of Ranbaxy’s ANDAs originating from the plant due to violations at the facility, and Ranbaxy hired Parexel Consulting Inc. to create business and manufacturing audits to address FDA’s issues. The government issued subpoenas in 2007 to Ranbaxy and Parexel for the audit documents. Ranbaxy believes the documents are protected by the attorney-client and work product privileges and strongly denied the DOJ’s allegations. ...