Quality & regulatory

Commitment to quality

We deliver quality in every aspect of our work, across all of our facilities, systems and teams. Whether we’re in the early stages of development or the final manufacturing process, we ensure that everything we do is to an exceptionally high standard. Our dedicated team are passionate about ensuring quality in all parts of the process, delivering a high-quality product every time.

Our expert team are always well prepared for inspections from regulatory agencies and routinely host more than 200 customer audits each year.

Where required we also follow strict ISO 14001 environmental policies and ISO 9000 quality systems, ensuring our work meets the appropriate standards and regulations.

Quality by Design (QbD)

We take a Quality by Design (QbD) approach at Cambrex, which includes employing statistical, analytical and risk management techniques in the design, development and manufacturing process to ensure their consistent quality.

Ultimately, you can trust us to go beyond the necessary quality standards expected of a contract development and manufacturing partner.

Commitment to regulatory excellence

We are proud of our long history of regulatory excellence.

Our products are specifically manufactured to meet strict cGMP standards, and our facilities are routinely audited by agencies worldwide – all helping to ensure a high level of regulatory excellence.

What’s more, we have a team of regulatory affairs experts on board that are actively involved in maintaining good manufacturing requirements.

Our recent audit history

North America:

Agawam, MA, USA (analytical services facility)

  • FDA (USA), 2018

Charles City, IA, USA (drug substance facility)

  • DEA (USA), 2018
  • FDA (USA), 2016
  • DHMA (EU), 2015
  • KFDA (South Korea), 2012
  • MHRA (UK), 2011

Durham, NC, USA (drug substance and analytical services facility)

  • DEA (USA), 2018
  • NC DHHS, 2019
  • DEA (USA), 2019

High Point, NC, USA (drug substance facility)

  • DEA (USA), Annually
  • FDA (USA), 2014

Longmont, CO, USA (drug substance, drug product and analytical services facility)

  • DEA (USA), 2018
  • FDA (USA), 2018

Mirabel, Québec, Canada (drug product facility)

  • FDA (USA), General GMP, 2017
  • Health Canada Narcotics License Inspection, Compliant, 2018
  • FDA Pre-Approval (Tablet), Compliant, 2015
  • Health Canada, General GMP, Controlled Drug (Schedule G), OTC, API Importation, Category IV Monograph, Narcotic and Prescription (Schedule F), Compliant, 2018

Whippany, NJ, USA (drug product facility)

  • FDA (USA), 2018
  • 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

Europe:

Karlskoga, Sweden (drug substance facility)

  • FDA (USA), 2016
  • MPA (Sweden), 2016
  • Korean MFDS, 2015

Paullo (Milan), Italy (drug substance facility)

  • FDA (USA), 2017
  • AIFA (Italy), 2017
  • ANVISA (Brazil), 2012

Get in touch with Cambrex

Want to know more about our products and services? It’s easy to get in touch, just head over to our contact page.

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