Ranbaxy falls on FDA import alert

Shares of Ranbaxy Laboratories Ltd. (NSE:RANBAXY; BSE:500359) fell 30% on Monday after FDA issued an import alert on drug products manufactured at the company's facility in Mohali, India, due to "significant" cGMP violations. The agency added the facility to an existing January 2012 Consent Decree against Ranbaxy, which prohibits the facility from manufacturing FDA-regulated drugs until it is in compliance with cGMP standards. The Consent Decree originally addressed outstanding cGMP and data integrity issues at Ranbaxy facilities in Paonta Sahib and Dewas, India. The facilities have been on an FDA import alert since 2008 (see BioCentury Extra, Dec. 21, 2011).

FDA said inspections in September and December 2012 identified violations at the Mohali facility that included failure to adequately investigate manufacturing problems and failure to establish adequate procedures to ensure manufacturing quality. Ranbaxy is required to hire a third-party expert to conduct a thorough inspection of the facility and certify to the agency that the facilities, methods, processes and controls are adequate to ensure continuous cGMP compliance. Ranbaxy could not be reached for comment in time for publication. ...