Noramco, a global leading producer of controlled substances for the pharmaceutical industry, and AMPAC Fine Chemicals (AFC), a major manufacturer of Active Pharmaceutical Ingredients (APIs) with cGMP facilities in the US, have agreed to form a strategic partnership to produce certain US Drug Enforcement Agency (DEA) controlled substances.

Indications will be treatment of addiction and abuse prevention, along with cannabinoids for clinical indications and treatment of attention deficit hyperactivity disorder (ADHD).  

Terms foresee Noramco continuing to market the products, while AFC will act as the contract manufacturer to supplement existing Noramco capacity.  The two companies have a long-standing relationship.

The DEA’s Schedule II and III controlled substance APIs are bulk actives for regulated pharmaceutical finished-dose customers. According to Noramco, 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, Virginia, with the DEA. This complements its existing state-of-the-art controlled substance manufacturing capabilities at Rancho Cordova, California. Noramco said the Virginia facility will give it additional capacity to meet growing demand, along with a support facility to complement its in-house capabilities in Wilmington, Delaware.

Noramco President and CEO James Mish said the company 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 its expectations.