uip

The University of Iowa Pharmaceuticals

1974 to 2014!

University of Iowa Pharmaceuticals celebrates 40th anniversary of gmp compliance

UI Pharmaceuticals is celebrating its 40th anniversary of producing cGMP drug products for use in clinical trials and commercial sale this month!  A lot has changed in 40 years, but UI Pharmaceuticals continues to provide cGMP contract services to the pharmaceutical industry.  Thanks to all of those who have used our services over the years.  UI Pharmaceuticals looks forward to providing cGMP pharmaceutical contract services for another 40 years and beyond!

Dale E. Wurster Endowment

The Dale E. Wurster Research Award in Pharmaceutics recognizes individuals who have made significant research contributions to the field of Pharmaceutics.  This research may be in the areas of physical pharmacy, preformulation, dosage form design, formulation, biopharmaceutics, and/or pharmacokinetics. This award was created and generously funded by Dean and Professor Dale E. Wurster for twenty years.  A fund raising initiative has been launched to permanently fund the award via an endowment. This reflects the strong support to memorialize Dean Wurster’s scientific contributions and to recognize him as a founder of AAPS.   University of Iowa Pharmaceuticals and College of Pharmacy will be the lead corporate sponsor of this endowment. 

New dOSAGE FORM APPROVAL

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.

UIP Featured in newscast

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.

 

 

 

OVERVIEW

The University of Iowa Pharmaceuticals (UIP) 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 (cGMPs) for 40 years!
  • The facility is the only one of its kind offering the range and scope of services needed by commercial clients.
  • Virtually every type of dosage form can be produced.
  • 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, Centers for Disease Control, National Institutes of Health, and 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 the EU and passed numerous QP audits.
  • QP release services are available through Russell Thomson of TPQ Consultancy.

CONTACT US

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.,
UIP Director
E-mail: mickey-wells@uiowa.edu

Randy R. Yeates, R. Ph., M.B.A.,
Director, Business Development
E-mail: randhall-yeates@uiowa.edu

Visits & Directions

OTHER NEWS & EVENTS

July 2014: UIP has received and is in the process of qualifying a new FP Developments Model 1270-2017 Semi-Automatic Vial Inspection Machine ... Read More...

June 2014: UIP has completed renovation of an approximately 300 square foot space ... Read More...

March 2014: UIP has purchased and received a new 225 gallon stainless steel mixing tank ... Read More...

December 2013-January 2014: In another round of new hiring UIP has hired four additional employees. New personnel include two... Read More...

December 2013: UIP has received and qualified two new Distek Symphony 7100 Dissolution Units with ... Read More...