Controlled substances

Looking for controlled substance API expertise and infrastructure, combined with safe and secure handling? Turn to Cambrex.

We are one of the few companies licensed to import narcotic raw materials at commercial scale, and routinely manufacture and distribute Schedule II-V controlled substances throughout the world.

Our amphetamines and opiates API development and manufacturing capabilities include:

  • US Drug Enforcement Agency (DEA) license for process research, development, manufacture and importation
  • Drug Master Files for more than 20 controlled substance APIs

Our experienced team have expertise in manufacturing highly potent opioids for:

  • Pain management
  • Addiction treatment
  • Obesity control
  • Neurostimulants
  • ADHD
  • Benzodiazepines

During controlled substance manufacture, we follow a number of security and laboratory controls in addition to highly regimented training and safety protocols to ensure the safe handling of controlled substance APIs.

Security

  • Highly secure, controlled access to:
    • Development and production suites
    • Waste management systems
    • Raw materials, intermediates and storage facilities
  • Specialized handling procedures for receiving, transferring, packaging and shipping material

R&D Laboratory controls

  • Dedicated laboratory equipment
  • Key card security system

Training & safety

  • Highly regimented safety protocols and PPE requirements
  • Personnel experienced in handling controlled substances and hazardous materials
  • Highly controlled document protocols and procedures

High potent controlled substances

  • Airlock and cascading pressure differentials to prevent cross contamination
  • Barrier isolation technology
  • Separate gowning, misting and de-gowning areas
  • Equipment cleaning validations at extremely low levels (25 ng/sample)

Find out more

For more information on our controlled substance API services:

Download our information sheet