American Injectables offers a one-stop-shop from development, including clinical phases, to commercialization for injectables in syringe, cartridges and vials.

Product Development

  • QbD holistic approach
  • Formulation development
  • Method development for analytical and micro
  • Lab scale stability
  • Filter selection and compatibility

Tech Transfer

  • Rapid site transfers of already developed or commercialized injectables
  • Tech transfer team with optimized and tested transfer plans
  • ICH stability studies
  • Full analytical and micro capabilities

Drug-Device Specialists

  • Experts in drug-device combination product development
  • Ready to use devices such and pre-filled syringes or pens
  • Fully compliant 21 CFR Part 4 streamlined QMS


  • 2R-50R RTU tray vial glass or plastic
  • 1 mL long, 1-3 mL, 5 mL, 10 mL, 50 mL RTU nested syringes
  • 1.5 mL and 3 mL RTU cartridges
  • Peristaltic and rotary piston pump filling
  • Pre-configured for highly viscous

Device Assembly

  • Assembly of cartridge devices for 1.5 and 3 mL formats
  • Device agnostic
  • Space and options for fully automated high volume assembly

Packaging and Serialization

  • Serialization system integrated at line and cloud level
  • Fully compliant with DSCSA current and planned requirements
  • Simple process to add new products