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
- 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)
