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Noramco, AMPAC in Strategic Scheduled API Pact

AFC will serve as a contract manufacturer to supplement Noramco’s existing capacity

By: Kristin Brooks

Managing Editor, Contract Pharma

Noramco, Inc., a global producer of controlled substances for the pharmaceutical industry, and AMPAC Fine Chemicals (AFC), a manufacturer of Active Pharmaceutical Ingredients (APIs) with cGMP facilities in the U.S., have entered 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). AFC will serve as a contract manufacturer to supplement Noramco’s existing 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 precise quality requirements.
 
AFC recently registered its large-scale controlled substance manufacturing plant in Petersburg, VA, with the DEA further adding to existing controlled substance manufacturing capabilities at Rancho Cordova, CA. The Virginia facility gives Noramco the extra capacity it needs and a support facility to complement its in-house capabilities in Wilmington, DE.
 
Noramco president and chief executive officer, James Mish said, “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. It’s the first company we have found that integrates well with Noramco’s operations and strategic focus. As the abuse deterrence, cannabinoids, and ADHD markets expand and diversify, be it new compounds, or development of traditional products for use in novel delivery systems, Noramco is making new innovations possible for customers.”
 
Dr. Aslam Malik, president and chief executive of AMPAC Fine Chemicals, added, “AFC has enjoyed a long-standing relationship with Noramco in supporting the production of their controlled substances. AFC’s strategic objective is value-created growth achieved by continuing to serve our key customers through excellent relationship management, by expanding our product lines, and applying our core technologies to their critical needs.”

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