The Kansas City District Office of the FDA submitted a recommendation of approval to the Center for Drug Evaluation and Research for The University of Iowa Pharmaceuticals (UIP) to manufacture an aseptically filled sterile, prescription drug product for a client. The drug product contains a new chemical entity and is a sterile solution that is aseptically filled into a vial.

The FDA recommendation followed a Pre-Approval Inspection (PAI) of UIP’s facilities and procedures and review of the product’s manufacturing and testing procedures based on the client’s NDA. The inspection covered cGMPs as well as specific information related to the manufacture and analytical testing of the product.

“This accomplishment validates the significant upgrades UIP has made in its sterile products manufacturing area and quality systems to support our goal of providing contract services for new pharmaceutical products from inception through commercial launch and beyond,” said Mickey L. Wells, Ph.D., director of UI Pharmaceuticals.