The FDA recently submitted a recommendation of approval to the Center for Drug Evaluation and Research (CDER) for UPM Pharmaceuticals to manufacture a low-dose tablet product. The recommendation was the culmination of a FDA Pre-Approval Inspection (PAI) of UPM’s facility and the manufacturing process for an NDA for one of its clients. The inspection covered general GMPs as well as product specific information. “This accomplishment represents a significant achievement in UPM’...