Successful PRE-APPROVAL INSPECTIONS FOr uip

University of Iowa Pharmaceuticals MANUFACTURING FACILITY Passes Non-Sterile TOPICAL Drug Product Pre-Approval Inspection WITH NO 483 ITEMS

In December 2011, the Kansas City District Office of the Food and Drug Administration (FDA) submitted a recommendation of approval to the Center for Drug Evaluation and Research for The University of Iowa Pharmaceuticals (UIP) to manufacture a topical non-sterile prescription drug product for a commercial client. The drug is intended for the treatment of a rare form of cancer. This recommendation followed an FDA Pre-Approval Inspection of UI Pharmaceutical's facilities and procedures and review of the product’s manufacturing and testing procedures described in the client’s New Drug Application. The inspection covered current Good Manufacturing Practices and specific information related to the manufacture and testing of the product.  UI Pharmaceuticals’ manufacturing facility received no 483 items as a result of this inspection.  "This accomplishment validates the significant enhancements UI Pharmaceuticals has made in its quality systems and breadth of services to support our goal of providing contract services for new pharmaceutical products from inception through commercial launch and beyond," said Mickey Wells, Ph.D., director of UI Pharmaceuticals. This FDA approval represents the third approval in the past 28 months for UI Pharmaceuticals to provide manufacturing and/or analytical testing services to clients in support of commercial products. "UI Pharmaceuticals looks forward to continuing to work with client organizations to support their formulation development, clinical trial and commercial product manufacturing and testing needs," said Donald Letendre, Ph.D., dean of the UI College of Pharmacy.

UNIVERSITY OF IOWA PHARMACEUTICALS PASSES PRE-APPROVAL INSPECTION FOR AN ASEPTICALLY FILLED STERILE DRUG PRODUCT.

On August 27, 2009, the Kansas City District Office of the Food and Drug Administration (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 drug product for a commercial client.  The drug product contains a new chemical entity and is a sterile solution that is aseptically filled into a vial. This recommendation came after an FDA Pre-Approval Inspection (PAI) of UIP’s facilities and procedures and review of the product’s manufacturing and testing procedures described in the product’s NDA.  The inspection covered general GMPs as well as specific information related to the manufacture and analytical testing of the product. This FDA approval represents the second approval for UIP to provide manufacturing and/or testing services to a client in support of a commercial product this year.  UIP looks forward to continuing to work with client organizations to support their formulation development, clinical trial and commercial product manufacturing and testing needs.