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API Manufacturing & CGMP

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HOW CAN WE HELP YOU?

Our drug substance manufacturing services use an integrated process evaluation and development approach for safe, compliant, and robust API manufacturing and CGMP processes. Our FDA inspected facility has clean rooms and cGMP chromatography.

  • ISO 9001:2008 quality system
  • FDA inspected facility
  • 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)