IOWA CITY, Iowa--The University of Iowa Pharmaceuticals (UIP) client, Ceptaris Therapeutics, Inc., a privately held, specialty pharmaceutical company, announced on August 26th that the U.S. Food and Drug Administration (FDA) has granted marketing approval for VALCHLOR (mechlorethamine ) gel 0.016%, a product that will be commercially manufactured by UIP.
Ceptaris Therapeutics, Inc. contracted with UIP to scale-up, manufacture, and test this product and be the commercial manufacturer for marketed product. This is the second commercial prescription product approved for a UIP client in the past 4 years. In 2009, a UIP client received approval for a New Molecular Entity (NME) in an injectable dosage form. The FDA only approved 20 NMEs in 2009. Ceptaris' approval is approximately the nineteenth FDA approval for a new dosage form' in 2013 per the FDA's website, Drugs@FDA.
About the University of Iowa Pharmaceuticals (UIP) and UIP Development Consortium (UIPDC)
The University of Iowa Pharmaceuticals (UIP) is the largest and most experienced university-affiliated FDA-registered pharmaceutical manufacturing facility in the United States for non-sterile and sterile dosage forms. UIP is a service division within the UI College of Pharmacy and also has a formal connection for pharmaceutical development with faculty called the University of Iowa Pharmaceuticals Development Consortium (UIPDC). UIP has been developing formulations, manufacturing products, and conducting analytical testing in compliance with current Good Manufacturing Practices (cGMPs) for almost 40 years. UIP serves a broad spectrum of clients of all sizes in the pharmaceutical and biotechnology industries and has performed work for pharmaceutical companies throughout the United States and the world. Additionally, UIP has performed work for numerous government agencies, including the National Cancer Institute, the Centers for Disease Control, the National Institutes of Health, and the Food and Drug Administration. UIP is an FDA-registered facility compliant with 21 CFR parts 11, 210, and 211, licensed by the DEA to handle controlled substances (Schedules I - V), and capable of handling potent/cytotoxic materials. UIP has produced numerous products for use in EU clinical studies and passed numerous QP audits. Please visit http://uip.pharmacy.uiowa.edu/ for more information about UIP and http://uip.pharmacy.uiowa.edu/uipdc.html for more information about UIPDC.
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