AMPAC Fine Chemicals (AFC) is a custom manufacturer of active pharmaceutical ingredients (APIs, Drug Substances) and registered intermediates for customers in the pharmaceutical industry. Our integrated facilities located in California, Texas, and Virginia specialize in process development, scale-up, and cGMP compliant production from kilograms to multi-ton quantities.

With over 75 years of experience in mastering challenging chemistries, we have developed capabilities that support a wide range of processes and technologies. AFC has over 158,000 gallons (598 m³) of manufacturing capacity and is capable of handling all scales of production. Our products are manufactured in full compliance with the U.S. Food and Drug Administration’s (FDA) current Good Manufacturing Practices (cGMP).

AFC Specializes In:

  • Energetic Chemistries
  • High Potency APIs (HPAPIs)
  • Chromatographic Separations (SMB)
  • Continuous Processing
  • U.S. DEA Controlled Substances (Schedule II-V)
  • Specialized Chemical Capabilities

Process R&D Supports Products At All Phases of Development:

  • New Route Development
  • Process Development to Generate Commercially Viable Route
  • Technical Transfer of Existing Route and Process
  • Detailed Process Design, Including DOE, to Support Validation Activities
  • Production of Intermediates and API to Support Clinical Trials
  • Continued Optimization of Commercial Processes
  • Full Process Safety Assessment
  • Analytical Method Development Services to Support all Development and Scale-up Activities
  • Identification and Assessment of Cost Effective and Reliable Raw Material Suppliers

AMPAC Analytical:

Laboratory Services for Drug Substances and Drug Products:

  • Release Testing
  • Method Development
  • Method Validation/Transfer
  • Stability Program
  • Reference Standard Qualification
  • Compendia Testing
  • Compound Characterization
  • Elemental Impurities
  • Routine Analytical Testing

AFC’s Ongoing Initiatives:

  • Lean Manufacturing Cultural Enhancement for cGMP Manufacturing
    • Kaizen events with diversified teams from all aspects of the business
  • War on Foreign Objects and Debris (FOD)
    • Actively engaged in prevention program to eliminate FOD from all sources
  • Right First Time: Quality and Documentation
  • Capacity Enhancements – Commercial and Medium Scale cGMP Manufacturing
  • Improved Supply Chain Management
    • Key Partnerships in China, Europe, India, Japan, and U.S.