Dishman Carbogen Amcis’ wholly owned subsidiary -- Carbogen Amcis AG's manufacturing site in Neuland, Switzerland, has successfully completed a U.S. Food and Drug Administration (USFDA) pre-approval inspection. The inspection was concluded with no Form 483's filed, thus confirming that no critical or major observation was raised during the inspection. The auditor will recommend the approval of API for which the audit was conducted.
The Hunzenschwil facility is one of Carbogen Amcis AG's four sites to offer development and manufacturing facilities for highly potent compounds. It manufactures products according to cGMP standards and is routinely inspected by Swissmedic, the FDA and external customers.
Dishman Carbogen Amcis provides innovative solutions for the development and supply of drug substances and drug products to the pharmaceutical and biopharmaceutical industries.
