Noramco, Ampac Fine Chemicals Form Strategic Alliance for Controlled Substances APIs
Noramco, a Wilmington, Delaware-headquartered producer of specialty active pharmaceutical ingredients (APIs), has partnered with Ampac Fine Chemicals (AFC), a Rancho Cordova, California-headquartered API manufacturer, to produce certain US Drug Enforcement Administration (DEA) controlled substances for use in treating addiction, abuse prevention, cannabinoids for clinical indications, and for treating attention deficit hyperactivity disorder.
Noramco will continue to be the marketer and will use 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 cGMP production assets and analytical equipment to meet quality requirements, according to Noramco.
AFC recently registered its large-scale controlled substance manufacturing plant in Petersburg, Virginia with the DEA, thereby adding to existing controlled-substance manufacturing capabilities at its facility in Rancho Cordova, California. The Virginia facility gives Noramco extra capacity and a facility to add to its in-house capabilities in Wilmington, Delaware.
Source: Noramco