The University of Iowa Pharmaceuticals (UIP) is the largest university-affiliated FDA-registered pharmaceutical manufacturing facility that manufactures both sterile and non-sterile dosage forms in the United States.
- UIP has been developing formulations, manufacturing products (for both clinical use and commercial sale), and conducting analytical testing in compliance with current Good Manufacturing Practices (cGMPs) for over 40 years.
- UIP serves a broad spectrum of pharmaceutical and biotechnology companies throughout the United States and the world.
- UIP is FDA-registered and 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, been inspected by the EMA, and passed numerous QP audits.
Lyophilization cycle development.
Solid oral dosage forms (tablets and capsules) manufacturing, including controlled release products.
Over-encapsulation and comparator manufacturing.
Oral liquid and topical gels, creams, lotions, and ointments manufacturing.
Analytical method development and validation.
API and raw material release testing.
Routine in-process and finished product testing.
Stability sample storage and testing.