Our major products are Active Pharmaceutical Ingredients (APIs), custom chemical synthesis products, and industrial fine chemicals. We supply our products to hundreds of customers in some 46 countries world-wide, including the major Regulated markets in Europe, North America and Japan. All our products are produced under cGMP, as defined in ICH Q7A (www.ich.org).
The majority of these products is used in human drugs to treat epilepsy, migraine or bipolar mood disorder. However, we also offer actives used in the treatment of inflammation, bacterial infection and thalassemia. Drug Master Files in CTD format are available for many countries, including Japan, and European Certificates of Suitability (‘CoS’) have been issued for our major APIs marketed in Europe.
We produce several products exclusively for specific customers.We have an active interest to expand this business. We guarantee full confidentiality, a quick scaling up from R&D to commercial scale, and a long term relationship based on mutual trust. Our main strength is in cGMP products with yearly volumes between 100 kg and 100 tonnes.
The major volume of our fine chemicals is used in the production of APIs and other actives. A range of small volume fine chemicals is used in a variety of industrial applications. We can for example offer you a wide range of substituted Pyrimidines, Pyridines and Pyrazoles.
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Since 2009, Katwijk Chemie has been certified as an Authorised Economic Operator (AEO) by the Dutch customs authorities. This will further ensure smooth and timely shipments of our products outside the European Union. The AEO system is similar to C-PAT certification in the USA.
Katwijk Chemie generally has several new products in active development. In close cooperation with partners and customers, we identify suitable new products and manage projects for further development.
We have an active interest to develop and produce additional new products, in the volume range from 50 kg to 100 tonnes per year. We look forward to review any requirement you may have.
In compliance with the REACH1 regulation in the European Union, all our fine chemical products have been preregistered in 2008. APIs are exempt from registration under REACH, because they are used in pharmaceutical products. The corresponding preregistration reference numbers are given in our Product list. Katwijk Chemie is participating in a number of SIEF groups, to ensure timely registration for the relevant products. The registration deadline for most of our products is 2018.
1 Registration, Evaluation, Authorisation and Restriction of Chemical substances.