Controlled Substances

Our amphetamines and opiates 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 and to ensure the safe handling of controlled substance APIs.

Security

  • Highly secure, controlled access to development and production suites
  • Highly secure, controlled access to waste management systems
  • Highly secure, controlled access to raw materials, intermediates and storage facilities
  • Specialized handling procedures for receiving, transferring, packaging and shipping material

R&D laboratory controls

  • Dedicated laboratory equipment
  • Keycard security system

Training and 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 substance

  • 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)

For more information on our controlled substance API services:

Download our information sheet.