At Cambrex, we take pride in our long history of regulatory excellence.

Our commitment to Good Manufacturing Practice (GMP) shows in our products and GMP facilities. Our products meet strict current GMP standards, and agencies worldwide routinely audit our facilities, helping us ensure a high level of regulatory excellence.

We have a team of regulatory affairs experts on board who actively maintain good manufacturing requirements. They ensure that our GMP manufacturing processes are optimized to deliver high-quality products consistently, meeting and exceeding regulatory requirements.

Our commitment to regulatory excellence is reflected in the trust that our customers and partners place in us. Our GMP facilities and regulatory affairs experts give us confidence in our ability to deliver the highest quality products and services. You can see our recent audit history below:

  • Agawam, MA – ANAB (ISO 107025:2017), 2021; FDA (USA), 2019
  • Charles City, IA – FDA (USA), 2022; DEA (USA), 2018; DHMA (EU), 2015; KFDA (South Korea), 2012; MHRA (UK), 2011
  • Durham, NC – FDA (USA), 2020; DEA (USA), 2019; NC DHHS, 2019
  • High Point, NC – DEA (USA), Annually; FDA (USA), 2014
  • Longmont, CO – DEA (USA), 2018; FDA (USA), 2018
  • Mirabel, Québec – FDA (USA), 2023; FDA Pre-Approval (Granule, Tablet), Compliant, 2019; Health Canada, General GMP, Controlled Drug (Schedule G), OTC, API Importation, Category IV Monograph, Narcotic and Prescription (Schedule F), Compliant, 2018; Health Canada Narcotics License Inspection, Compliant, 2018; FDA General cGMP, Compliant, 2017; FDA Pre-Approval (Tablet), Compliant, 2015
  • Whippany, NJ – FDA (USA), 2023; ANVISA (Brazil), 2022; DEA (USA), 2018; General Inspection and 1 Pre-Approval, Compliant and Recommended for Approval, 2018; PAI, Recommended Approval, 2017; General Inspection, Compliant, 2017; MHRA (UK), 2017; 2 Pre-Approval and 1 Post Approval, Compliant, 2016; GMP certificate issued, 2015
  • Edinburgh, United Kingdom – BSI (ISO 9001), 2022
  • Karlskoga, Sweden – MPA (Sweden), 2022; FDA (USA), 2016; Korean MFDS, 2015
  • Paullo (Milan), Italy – FDA (USA), 2022; AIFA (Italy), 2021; ANVISA (Brazil), 2012