Contract Pharmaceutical Development, Manufacturing, and Testing Services
As the largest and most experienced university-affiliated FDA-registered pharmaceutical manufacturing facility in the United States that produces both sterile and non-sterile dosage forms, we have been developing formulations, manufacturing products, and conducting analytical testing for almost 45 years. UIP can support the manufacturing and testing of both clinical and commercial products.
Overview
University of Iowa Pharmaceuticals (UIP) provides contract pharmaceutical services including pharmaceutical development, manufacturing, and testing. UIP can support the manufacturing and testing of both clinical and commercial finished products.
UIP is a Food and Drug Administration-registered pharmaceutical manufacturing facility, providing expert pharmaceutical development services to clients around the world.
Contract pharmaceutical services include:
• Preformulation studies
• Formulation development (including lyophilization cycle development)
• Clinical supply manufacturing and testing
• Small scale commercial manufacturing and testing
• Analytical method development and validation
• Routine quality control analysis
• Stability studies
• Active pharmaceutical ingredient (API) and excipient release testing
We are able to handle controlled substances schedules I - V and most potent and/or cytotoxic substances. UIP is able to manufacture most dosage forms including sterile solutions and lyophilized powders; tablets; capsules; and non-sterile semisolids and liquids.
UIP is the largest and longest running facility of its kind offering this breadth of services in the United States, and has been providing contract pharmaceutical services in compliance with current Good Manufacturing Practices (GMP) for almost 45 years.
Browse our list of services, or Contact Us, to find out how UIP can assist you with contract pharmaceutical development, manufacturing, and testing services.
News and Events
Articles published in IowaNow and the Gazette featuring UI Pharmaceuticals initiative to manufacture hand sanitizer for UI Hospitals & Clinics. Click links to read the full articles.
https://now.uiowa.edu/2020/03/ui-pharmaceuticals-addresses-need-hand-san...
https://www.thegazette.com/subject/news/education/university-of-iowa-pha...
University of Iowa Pharmaceuticals (UI Pharmaceuticals), a division of the University of Iowa College of Pharmacy, supported Lixte Biotechnology Holdings, Inc. in by manufacturing clinical drug supplies of Lixte’s investigational drug LB-100.
An article was published on 01/30/2020 in IowaNow featuring UI Pharmaceuticals 16000 sq feet new-state-of-the-art sterile manufacturing facility.
Randy Yeates, Director of Business Development at UI Pharmaceuticals will be presenting the talk titled “U of Iowa Pharmaceuticals - Innovative Facility/Process Design and Delivery” at the ISPE Sterile Processing meeting at Rockville, MD on 03 March 2020.
Intercept Pharmaceuticals, Inc. received FDA approval for the orphan drug Ocaliva® – one of only 22 NMEs (New Molecular Entities) to receive approval by the FDA in calendar year 2016! UIP’s analytical laboratory is a laboratory of record in their NDA for this drug product.
University of Iowa Pharmaceuticals is continuously improving its operations, adding new capabilities, and announcing collaborations on new and exciting projects. Come take a look at all of our news, including events where we will be exhibiting!