cGMP Manufacturing

image of SwRI scientist in a lab

image of capsul bottles

Our drug substance (Active Pharmaceutical Ingredient) manufacturing services utilize our Integrated Process Evaluation and Development Services to develop and execute safe, compliant and robust cGMP manufacturing processes.

  • FDA inspected facility
  • ISO 9001:2008 quality system
  • Clean rooms (10,000––100,000)
  • Gram to kilogram scale manufacturing
  • Technology transfer
  • cGMP chromatography services
  • Specialized dosage forms
    • Tablets/capsules
    • Controlled release
    • Drug releasing implants
    • Parenteral/injectable (terminal sterilization)
      • IM, IV, IP, intraarticular
      • Intranasal, inhalation
  • High potency and controlled substances (Schedule II-V)
Benefiting government, industry and the public through innovative science and technology
Southwest Research Institute® (SwRI®), headquartered in San Antonio, Texas, is a multidisciplinary, independent, nonprofit, applied engineering and physical sciences research and development organization with 9 technical divisions.