Active Pharmaceutical Ingredients

Katwijk Chemie has been producing Active Pharmaceutical Ingredients (APIs) for over a century. All our APIs are commercial-scale small molecules. These products have been exported for decades to European countries, the United States, Japan and various other countries worldwide. Our customer portfolio is diverse and it includes large multinational generic pharmaceutical companies as well as originators.

All APIs are manufactured in our own plant in The Netherlands under current Good Manufacturing Practice (cGMP) guidelines. Drug Master Files (DMFs) have been registered in many countries, including Japan. European Certificates of Suitability (CEPs) have been issued for our major APIs marketed in Europe. Most DMFs registered with the United States Food & Drug Administration (USFDA) are Available for Reference.

A large part of our APIs is used in human drugs to treat epilepsy, migraine, or bipolar mood disorder. We also offer actives in other therapeutic areas such as in the treatment of inflammation, bacterial infections and thalassemia.

New Products

Katwijk Chemie generally has several new products in active development.
In close cooperation with customers we evaluate feasibility and manage projects step-by-step. For process development we often involve partner companies, such as Contract Research Organisations (CROs), for specialized needs.
Our main strength is in products with volumes between 100 kg and 100 MT per year with up to 5 synthetic steps. We have experience in many types of processes, such as large scale cyanation and vacuum distillation.  We look forward to reviewing any requirements that you may have.

Quality Control – then & now

Your Benefits in APIs

  • More than 100 years of reliability
  • High and consistent product quality
  • All products manufactured in our plant in The Netherlands under cGMP
  • Quick and accurate quality support; US FDA inspected since 1976
  • Compliant with the highest European HSE standards
  • Medium-sized, agile and flexible
  • Family-owned and fully independent