The University of Iowa Pharmaceuticals


An FDA Inspector conducted a general cGMP and preapproval inspection of UIP in November 2015 (both the manufacturing and laboratory site were inspected). This preapproval portion of the inspection was for two different products; a generic sterile injectable solution manufactured by UIP and an oral, immediate release tablet product containing an NCE on which UIP performs finished product and stability testing. This latter product was originally formulated by UIP. The latter product is intended for the treatment of liver disease and is on an accelerated approval track. The inspector completed the inspection and did not leave a Form 483 at either site. This inspection brings to 4 the number of successful preapproval inspections UIP has hosted since 2009. This is a significant accomplishment for UIP.



University of Iowa Pharmaceuticals (UIP) is pleased to report that its long standing client, Intercept Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic underserved liver diseases, announced on June 29, 2015 that it has filed a New Drug Application for accelerated approval with the U.S. Food and Drug Administration (FDA) and acceptance of the Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for obeticholic acid (OCA) which is intended for the treatment of primary biliary cirrhosis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. 


Intercept Pharmaceuticals, Inc. contracted with UIP to develop a preliminary formulation and analytical testing methods for this product when it entered the drug development process.  As the product moved through the development process, manufacturing operations were moved to another facility due to scale limitations at UIP.  Analytical testing has continued to be performed by UIP, and UIP is named as a qualified laboratory for testing of commercial product intended for United States market.  This is the fifth commercial prescription product for which a UIP client has filed for regulatory approval with UIP named as a production and/or analytical testing site in the past 6 years.

The read more about this: http://ir.interceptpharma.com/releasedetail.cfm?ReleaseID=919926 

UIP Featured in chemical and engineering news may 2015

chemical and engineering news recently featured UIP in an article on University-created pharma and biotech SERVICE operations

The article touched on a number of issues including the need for university based service organizations to focus of satisfying customer needs and operating like a commercial enterprise to be successful.  Such facilities must combine solid technical skills with entrepreneurial drive.  Read more...

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. 


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 most 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.


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


June 2016: UIP has added two Waters ACQUITY QDa detector equipped LC systems to our analytical laboratory...Read More...

March 2016: UIP is in the process of adding 3 Manufacturing Specialists in the Non-Sterile Processing area... Read More...

Oct 2015: UIP has added additional staff including 3 chemists in the analytical laboratory and Ramprakash Govindarajan, Ph.D. who will be heading up our Preformulation/Formulation Development Group... Read More...

July 2015: UIP has added a second Waters ACQUITY UPLC H-Class System to our analytical laboratory... Read More...

June 2015: UIP has installed an additional 1120 cubic feet of frozen storage space... Read More...

April 2015: UIP has added a Waters ACQUITY UPLC H-Class System to our analytical laboratory... Read More...

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...