1.800.452.4682

Facilities

 
 

Facilities

 
 

Certified and Inspected by European and US Regulatory Agencies

St. Louis, Missouri Site

  • Acquired in 2009
  • FDA Inspected and Compliant with US FDA 21 CFR Part 210/211, 110/111, 117 and EU drug certification standards
  • Registered with the FDA as well as EU cGMP Certified by the Swedish Medical Products Agency (MPA)
  • This site has two core manufacturing capabilities:
    – Specialty microencapsulated particles
    – High shear granulated particles

Seymour, Indiana Site

  • Acquired in 2011
  • Major Expansion in 2014
  • FDA Inspected and Compliant with US FDA 21 CFR Part 210/211, 110/111, 117 and EU drug certification standards
  • Site is registered with the FDA and has Manufacturing Site GMP Approval by German Authorities
  • This site has three core manufacturing capabilities:
    – High-volume, aqueous-based spray drying
    – Finished dosage manufacturing (solid oral dosage forms)
    – Iron Deficiency Technology (Polysaccharide Iron Complex)

Tel: 1.800.452.4682
Email: info@particledynamics.com