Strategic partnership formed to produce US DEA controlled substances

Producer of controlled substances for the pharma industry, Noramco, has entered into a strategic partnership with active pharmaceutical ingredient (API) manufacturer, AMPAC Fine Chemicals (AFC), to produce specific US DEA controlled substances.

Under the terms of the partnership, the companies will work together in the production and marketing of certain APIs 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 be the marketer and will use AFC as the contract manufacturer.

The APIs to be produced are DEA Schedule II and III controlled substances for regulated pharmaceutical finished dose customers. As such, they require high quality cGMP production assets and sophisticated analytical equipment to meet very precise quality control.

“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,” said Noramco president and CEO, James Mish. “AFC brings core capabilities like our own. 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, providing everything that’s required to go to market reliably, safely, and on schedule.”

“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,” added Dr Aslam Malik, president and CEO of AMPAC Fine Chemicals. “The foundation of this growth is established through AFC's Core strengths in Process R&D and Process Engineering. Noramco’s demonstrated commitment to excellence in their products, people and customer support closely aligns with AFC’s. We are delighted to be in partnership with Noramco.”

Recently, AFC registered its large-scale controlled substance manufacturing plant in Petersburg, Virginia. This facility will give Noramco the extra capacity it needs to meet growing demand, and a support facility to complement its in-house capabilities in Wilmington, Delaware.