Noramco and AMPAC Fine Chemicals (AFC) announced a strategic partnership to produce certain US DEA controlled substances for use in the treatment of addiction, abuse prevention, cannabinoids for clinical indications, and for the treatment of attention deficit hyperactivity disorder (ADHD).
Noramco will continue to be the marketer and will utilize AFC as the contract manufacturer to supplement existing Noramco capacity.
The DEA Schedule II and III controlled substance APIs are bulk actives for regulated pharmaceutical finished dose customers. These drug substances require high quality cGMP production assets and sophisticated analytical equipment to meet very precise quality requirements.
AFC recently registered its large-scale controlled substance manufacturing plant in Petersburg, VA, with the DEA further adding to existing state-of-the-art controlled substance manufacturing capabilities at Rancho Cordova, California. The Virginia facility gives Noramco, Inc. the extra capacity it needs to meet growing demand, and a support facility to complement its in-house capabilities in Wilmington, Delaware.
“We investigated a number of sites and partners but only AFC has both the infrastructure and analytical capabilities in place that not only meet but exceed our expectations. AFC operates with excellence in both quality and reliability,” Noramco President and CEO, James Mish said.