Charles City

Overview

Cambrex Charles City is located in North Central Iowa on a 45-acre site in Charles City. The facility manufactures APIs, fine chemicals and pharmaceutical intermediates for a wide range of applications.

Cambrex Charles City operates:

• Large-scale commercial cGMP manufacturing facilities
• Pilot plant facilities with a variety of materials of construction
• High Potency Development Center
  • Dedicated ECB 4 chemical development and analytical labs with barrier isolation
  • Small scale cGMP lab up to 5 L
• cGMP kilo labs
• R&D development and analytical labs
• Controlled and regulated warehousing

The facility is one of a limited number of companies authorized by the DEA to import narcotic raw materials at commercial scale. Since 2002, the facility is licensed by the DEA to conduct the following for Schedule II-IV Controlled Substances:

• Process research
• Development
• Manufacture
• Importation

Facility Details

• 4 full-scale multi-purpose facilities
• cGMP pilot plant
  • 300 gallon glass-lined reactor
  • 100 gallon glass-lined reactor
  • 300 gallon stainless steel reactor
  • 100 gallon Hastelloy reactors
• cGMP kilo labs
• High Potentcy Development Center (ECB 4)
  • Controlled access
  • Micronization
  • Drying/packaging facility
  • Analytical and chemical development labs
  • Manufacturing scale from 1 L to 2000 L
• 48 reactors - 94,000 gallon capacity
• 10 centrifuges
• 10 dryers/4 nutsche filters
• Thin Film Evaporator
• Water for Injection system
• Wastewater treatment facility