FDA recommends approval for UI Pharmaceuticals to manufacture an aseptically filled sterile drug product

Oct 14 2009

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 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.

"This accomplishment validates the significant upgrades UI Pharmaceuticals 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 Wells, Ph.D., director of UI Pharmaceuticals.

This FDA approval represents the second approval this year for UI Pharmaceuticals to provide manufacturing and/or 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.

The September recommendation regarding UI Pharmaceuticals 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.

Story Source: University of Iowa Pharmaceuticals, College of Pharmacy, 115 South Grand Ave., G-20, Iowa City, Iowa 52242