UI Pharmaceuticals passes FDA inspection

In September 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 and test an aseptically filled, sterile prescription drug product for a commercial client. The drug product contains a new chemical entity and is a sterile solution that is aseptically filled into vials.

This recommendation followed an FDA pre-approval inspection of UIP 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.

The FDA approval represents the second approval this year for UIP to provide manufacturing and/or testing services to clients in support of commercial products.

The September recommendation regarding UIP to the Center for Drug Evaluation and Research, coupled with subsequent FDA approval the company received for its drug, means the company can sell the drug for approved indications and UIP can manufacture and test the product for the company.

UIP is the largest and most experienced university-affiliated, FDA-registered pharmaceutical manufacturing facility in the United States. It has been developing formulations, manufacturing products and conducting analytical testing in compliance with cGMPs for more than 30 years.