India’s Ipca halts shipments to U.S. from local plant after FDA concerns

By Zeba Siddiqui MUMBAI (Reuters) – India’s Ipca Laboratories Ltd said on Thursday it has voluntarily suspended shipments to the United States from one of its drug ingredient manufacturing plants after the U.S. Food and Drug Administration (FDA) expressed concerns regarding the unit. Ipca, a mid-sized generic drugs and ingredients maker, said the FDA issued a so-called “Form 483”, a letter in which the agency typically outlines violations of its guidelines observed during inspections of manufacturing plants. Ipca did not give details about the contents of the Form 483 that it had received. Over the past year, large Indian drugmakers such as Ranbaxy Laboratories Ltd and Wockhardt Ltd have been hit by a spate of regulatory sanctions due to concerns about production processes at their local plants.