India’s Lupin Says Ready To Present Mandideep Plan To U.S. FDA; Push On Novel Drug Delivery, Biosimilars And Indian Market To Propel Revenue Growth
This article was originally published in PharmAsia News
Executive Summary
MUMBAI - Indian drug maker Lupin hopes to clear up issues with U.S. regulators on its Mandideep-based manufacturing unit, which has been issued warning letters by the U.S. FDA. The FDA had charged the facility deviated from current good manufacturing practices in the production of oral and injectable cephalosporins in November 2008