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.
UIP is very excited to have been selected as a vendor for NCATS (National Center for Advancing Translational Sciences) Request for Proposal (RFP) No. N01TR-17-2003, “CRO Support for NCATS Drug Product Development, Manufacture, and Stability Studies”.
UIP collaborated with Fervent Pharmaceuticals to develop the formulation for its treatment for hot flashes and other vasomotor symptoms. UIP involvement also included manufacture of development-scale and clinical batches to support its Phase II clinical trial.
U.S. Secretary of Commerce Penny Pritzker announced on December 16, 2016 an award of $70 million to the new National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). This institute is funded by the U.S. Department of Commerce.
On September 29, 2016 UI officially broke ground on a new pharmacy building that will include a state-of-the-art contract sterile products processing facility equipped with fully isolated and automated filling lines utilizing single use technology.
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!