The University of Iowa Pharmaceuticals (UIP) received a recommendation of approval from the Kansas city district office of FDA to manufacture and test an aseptically filled, sterile prescription drug product for a commercial client, in September.
The company claims that the drug product contains a new chemical entity and is a sterile solution that is aseptically filled into vials. The recommendation of approval was submitted to the Center for Drug Evaluation and Research.
Reportedly, this recommendation followed an FDA Pre-Approval Inspection of UIP’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.
The company has said that 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.
Mickey Wells, director of UIP, said: “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.”
Donald Letendre, dean of the UI College of Pharmacy, said: “UIP looks forward to continuing to work with client organisations to support their formulation development, clinical trial and commercial product manufacturing and testing needs.”