Our API production is governed by a wide range of global certification systems to support the success of your pharmaceutical solutions. These include:

  • GMP (ICH Q7) certified production
  • Certificates of Suitability (CEPs)
  • Compliance with various compendia: USP/EP/JP

We collaborate with a wide range of authorities, including the US Food and Drug Administration (FDA), European Directorate for the Quality of Medicines (EDQM), and Health Canada (HC), to ensure our products continue to meet standards worldwide.  Furthermore, DSM closely collaborates with various industry associations, including: 

  • Active Pharmaceutical Ingredients Committee (APIC) 

  • International Pharmaceutical Excipient Councils (IPEC) Federation 

Contact us to find out how our comprehensive regulatory support can benefit your project.