Founded in the United States in 1961, Colorcon develops and manufactures science-based formulation and packaging solutions that help pharmaceutical, nutraceutical, and animal-health companies make solid oral medicines. Its roots in film coatings include the launch of flagship Opadry® in 1980, and the company now supports customers through more than 40 locations and 16 manufacturing facilities worldwide. Colorcon’s scale is paired with a strong technical and regulatory focus, including ISO 9001 certification at most sites.
ISO 9001
certification
EXCiPACT
certification
IPEC-PQG Joint Good Manufacturing Practices Guide for Pharmaceutical Excipients
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ISO 15378:2017 GMP
certification
FDA-Registered Facility
registration
Current Good Manufacturing Practice (cGMP)
compliance_program
FDA Compliance Assurance
compliance_program
EU Compliance Assurance
compliance_program
EcoVadis Top 15% Silver Sustainability Rating
certification