University of Iowa Pharmaceuticals and Ceptaris Therapeutics, Inc.
University of Iowa Pharmaceuticals (UIP) is pleased to report that its 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.
Quad Cities station KWQC recently featured a newscast that included uip
The focus of the news article was a family's efforts to organize and facilitate efforts to develop new drugs for Duchenne Muscular Dystrophy. As part of this effort UIP was approached by Halo Therapeutics in 2012 to develop a formulation for and manufacture a potential therapy for use in clinical trials. These tasks were completed, clinical trials are in progress, and efforts to further the development of this drug product are ongoing. Click here to view the news article called Charlie's Fund.
Successful PRE-APPROVAL INSPECTION FOr uip
In December 2011, 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 a topical non-sterile prescription drug product for a commercial client. The drug is intended for the treatment of a rare form of cancer. 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. UI Pharmaceuticals’ manufacturing facility received no 483 items as a result of this inspection. "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," said Mickey Wells, Ph.D., director of UI Pharmaceuticals. This FDA approval represents the third approval in the past 28 months for UI Pharmaceuticals to provide manufacturing and/or 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," said Donald Letendre, Ph.D., dean of the UI College of Pharmacy.
Please call or send an e-mail to discuss project needs, schedule a visit and tour, or audit our facilities and procedures. For more information please contact either of the following contacts:
Mickey L. Wells, Ph.D.,
Randy R. Yeates, R. Ph., M.B.A.,
Director, Business Development
June-July 2013: UIP has hired a number of new employees. New personnel include a Project Manager in the Non-Sterile Products Group... Read More...
July 2012: UIP has purchased a new Model GF SKPMP heated paste filler. Read More...
March 2012: UIP has purchased 4 new Millipore Integritest® 4 automated filter integrity test instruments. Read More...
October 2011: UIP will closely collaborate with the University of Rochester Clinical Materials Service Unit (CMSU) on the National Institute of Neurological Disorders and Stroke’s newly created Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT). Read More...
January 2011: UIP has added a 10 cubic foot V-blender to its Non-Sterile Products processing equipment set. Read More...