Ranbaxy ready for re-inspection
This article was originally published in The Gold Sheet
Executive Summary
Ranbaxy has asked FDA to re-inspect its Paonta Sahib and Dewas manufacturing sites in India, CEO Atul Sobti told PharmAsia News. The company has provided the agency a report explaining how it corrected problems FDA noted in previous inspections, and which led the agency in September to suspend imports of more than 30 products. A favorable re-inspection could enable Ranbaxy, now owned by Japanese drug maker Daiichi Sankyo, to resume U.S. exports (see "The Gold Sheet," March 2009, p. 11 and "The Gold Sheet," August 2008, p. 6)