Clariant adds new capability to US plant
Clariant is adding new capability to its cGMP Centre of Excellence, Springfield, Missouri, that will allow it to manufacture finished APIs which are considered controlled substances by the US Drug Enforcement Administration (DEA).
Clariant is adding new capability to its cGMP Centre of Excellence, Springfield, Missouri, that will allow it to manufacture finished APIs which are considered controlled substances by the US Drug Enforcement Administration (DEA).
It is initially being developed in conjunction with a project to manufacture a CNS drug, which is a Schedule II drug under the controlled substances act of the comprehensive drug abuse prevention and control act of 1970. Last July the DEA inspected the site and granted a research permit to produce small quantities of the drug.
The new capability will include investment in special manufacturing equipment to isolate production of this API, as well as filtration, drying, filling, drumming and weighing facilities. In addition, Clariant will institute security systems at Springfield to comply with the requirements of the DEA for controlled substances. Production of the API is targeted to commence in late 2005.
According to Dr Ralf Pfirmann, global business director for Clariant's pharmaceutical fine chemical business, the development of controlled substance capability at Springfield allows Clariant to become a commercialisation partner for the pharma industry where drugs and their intermediates are regulated by the DEA.