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UI Pharmaceuticals passes pre-approval for topical drug
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The Food and Drug Administration (FDA) has submitted a recommendation of approval to the Center for Drug Evaluation and Research for University of Iowa Pharmaceuticals (UIP) to manufacture a topical prescription drug product for a commercial client. The drug is intended to treat a rare form of cancer.
"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," says Mickey Wells, UIP director and associate professor of pharmaceutical sciences and experimental therapeutics at the University of Iowa College of Pharmacy.
The December 2011 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.
This FDA approval represents the third in the past 28 months for UI Pharmaceuticals to provide manufacturing and 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," says Donald Letendre, College of Pharmacy dean.
UI Pharmaceuticals is the largest and most experienced university-affiliated, FDA-registered pharmaceutical manufacturing facility in the United States. UIP has been developing formulations, manufacturing products, and conducting analytical testing in compliance with current Good Manufacturing Practices for over 37 years.
UIP serves a broad spectrum of clients in the pharmaceutical and biotechnology industries and has performed work for pharmaceutical companies throughout the United States and world. The unit alsohas worked with government agencies including the National Cancer Institute, the Centers for Disease Control, the World Health Organization, the National Institutes of Health and the FDA.