Cutting edge
API development
NCK provides cutting edge process development and API manufacturing for biotech and pharmaceutical companies who want to take NCEs from discovery to commercialization.
NCK has its own multi-purpose pilot plant facility operated under Good Manufacturing Practice (GMP). The facility consists of two individual pilot plants “the old pilot plant 24” and “the pilot plant 69”, two drying rooms, and several storage areas and utility rooms.
“The old pilot plant 24” (108 m2) is housed in a larger, single story concrete building and contains five production lines equipped with glass or glass-lined reactors, ranging from 40-280 L (-20°C to +150°C ) plus a 160 L steel reactor used for cryogenic reactions (-80°C).
Most of our projects involve either manufacturing of advanced stage intermediates or Active Pharmaceutical Ingredients (APIs) for pre-clinical and/or clinical trials, produced in accordance with cGMP.
NCK is committed to operating in compliance with GMP as defined by the ICH Q7 GMP Guide for APIs, and rules Governing Medicinal Products in the European Union, Vol. 4, Part II, concerning APIs for use in clinical trials.
Dr Niels Clauson-Kaas, a well-reputed university researcher, founded NCK in 1956. He wanted to create an innovative company with strong competences within research and development in the field of organic chemistry.
Today NCK provides cutting edge process development and API manufacturing (e.g. process development, analytical development, reference samples, supply of API for toxicology and human studies, API release, ICH stability studies as well as relevant progress reports and GMP documentation) for biotech and pharma companies who want to take NCEs from discovery to commercialization.
Davos Pharma
600 East Cresent Avenue
Upper Staddle River
New Jersey 07458
+1 201.995.0070
Chukan Butsu Ltd
7th Floor, Shiono Nissei Building
6-6, 2-Chome, Doshomachi
Chuo-Ku, Osaka, 541-0045
+81 06 6231 5127