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The University of Iowa Pharmaceuticals
The University of Iowa Pharmaceuticals is an FDA-registered (DMF 3794) pharmaceutical manufacturing facility, which occupies ~24,000 s.f. on the ground floor of the College of Pharmacy and ~7,000 s.f. at the UI Research Park. The University of Iowa Pharmaceuticals provides contract formulation development, analytical testing, and manufacturing (sterile products, solids, and semisolids) services. Products can be manufactured for development puposes, clinical trials, and commercial sale. Analytical capabilities include method development, raw material testing, preformulation research, product release testing, and stability studies. UIP is compliant with CFR 11, 58, 210 and 211, licensed with the DEA to handle controlled substances Schedules I to V, and capable of handling potent/cytotoxic materials.
Company Contact:
Mickey L. Wells, PhD
Phone:(319) 335-8674
Fax:(319) 335-9418
Email:mickey-wells@uiowa.edu
Website:http://www.pharmacy.uiowa.edu/uip/
Address:G-20 Pharmacy Building Iowa City, Iowa 52242-1112
Mickey L. Wells, PhDPhone:
(319) 335-8674Fax:
(319) 335-9418Email:
mickey-wells@uiowa.eduWebsite:
http://www.pharmacy.uiowa.edu/uip/Address:
G-20 Pharmacy Building Iowa City, Iowa 52242-1112- USA
ANALYTICAL
Service Type
MethodsMethod DevelopmentMethod TransferMethod ValidationTests - Dissolution/DisintegrationDisintegrationDissolution App. I/IITests - Impurities/DegradationForced DegradationImp./Deg QuantitationTests - PhysicalPhysical TestingTests - StabilityAccelerated StabilityICH/Commercial Stability StorageICH/Commercial Stability TestingPhotostabilityStability Storage (I/II)Stability Testing (I/II)Tests/Analysis - OtherAssay/PotencyComparator AnalysisCompendial TestingMoistureResidual Solvent AnalysisThermal Analyses/DSCWet Chemistry
FACILITY REGULATORY STATUS
Facility subcategories
FORMULATION/MANUFACTURING
API/Business Sector Types
Development Stage
PACKAGING/FILLING/LABELING
Development Stage
PREFORMULATION
General Properties
| Size of the Facilities (square feet) | 7000 |
| Number of People | 20 |
Equipment
| Equipment | Check if exist |
|---|---|
| HPLC | |
| LC-MS | |
| GC | |
| NMR | |
| Solid State NMR | |
| DSC | |
| TGA | |
| FTIR | |
| NIR | |
| Raman | |
| UV-Vis | |
| PXRD | |
| Particle Sizer | |
| Karl Fischer |
HPLC Stability Indicating Methods Developed for Oral formulations (last 3 years)
| Activity/Phase | Oral Tablet | Oral Liquid | Oral Softgel Capsule | Oral Hard Gel Capsule | ODT |
|---|---|---|---|---|---|
| Preclinical | |||||
| Phase I – II | 20 | 13 | |||
| Phase III –commercial | 2 |
General Properties
| Size of the Facilities (square feet) | 24000 |
| Number of People | 40 |
The number of ORAL dosage forms developed in-house within the last three years
| Activity/Phase | Oral Softgel Capsule | Oral IR Tablet | Oral MR Tablet | Oral Hard Gel Capsule | Hard Capsule/Liquid | ODT | Taste Masking | Oral Solution/Suspension | Oral Microcapsule/CR | Effervescent |
|---|---|---|---|---|---|---|---|---|---|---|
| Preclinical | ||||||||||
| Phase I – II | 100+ | 100+ | ||||||||
| Phase III –commercial | 1 | 1 |
The number of ORAL dosage forms manufactured using client supplied formulation technology within the last three years
| Activity/Phase | Oral IR Tablet | Oral MR Tablet | Oral Hard Gel Capsule | Oral Softgel Capsule | ODT | Oral Hard Capsule/Liquid | Oral Solution/Suspension | Taste Masking | Oral Microcapsule/CR | Effervescent |
|---|---|---|---|---|---|---|---|---|---|---|
| Preclinical | ||||||||||
| Phase I – II | 100+ | 100+ | ||||||||
| Phase III –commercial | 2 |
