University of Iowa Pharmaceuticals (UI Pharmaceuticals) is the largest and most experienced university-affiliated FDA-registered pharmaceutical manufacturing facility in the United States. UI Pharmaceuticals has been developing formulations, manufacturing products, and conducting analytical testing in compliance with cGMPs for almost 45 years. During the past 5 years UI Pharmaceuticals has manufactured over 1100 batches of product for over 100 different sponsors. UI Pharmaceuticals 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, UI Pharmaceuticals has performed work for numerous government agencies, including the National Cancer Institute, the Centers for Disease Control, and the National Institutes of Health. UI Pharmaceuticals is capable of producing most types of pharmaceutical dosage forms. These dosage forms include sterile injectable solutions; sterile lyophilized (freeze-dried) powders; topical and oral solutions, emulsions, and suspensions; tablets (uncoated and film or functional coated); and hard gelatin capsules (powder or hot melt filled). UI Pharmaceuticals is compliant with 21 CFR parts 11, 210, and 211, licensed by the Drug Enforcement Agency (DEA) to handle controlled substances (Schedules I - V) and capable of handling potent/cytotoxic materials. UI Pharmaceuticals has produced numerous products for use in the European Union (EU) and passed numerous Qualified Person (QP) audits.
Industry
Pharmaceutical Manufacturing
HQ Location
College of Pharmacy
115 South Grand Avenue, G-20
Iowa City, Iowa 52242, US
Keywords
Formulation DevelopmentClinical Supply ManufacturingAnalytical Testing ServicesSmall Scale Commerical ManufacturingAnalytical Method Development and ValidatioStability StudiesSterile FillingAPI Release TestingTablets and CapsulesLyophilizatio