Partnership struck to increase production of DEA controlled substances

Noramco, a producer of controlled substances for the pharmaceutical industry, and AMPAC Fine Chemicals (AFC), a manufacturer of APIs with cGMP facilities in the US, has 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 the extra capacity it needs to meet growing demand, and a support facility to complement its in-house capabilities in Wilmington, Delaware.

Noramco President and CEO, 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."

"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," Mish said.

Dr Aslam Malik, President and CEO 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."

"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," Malik said.

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