As the demand for controlled substance active pharmaceutical ingredients (APIs) has increased in recent years, so have the challenges for sponsors. Navigating the stringent regulations surrounding controlled substance manufacturing requires specialized expertise that many small and medium life science companies don’t have. Outsourcing is an attractive option, but it’s imperative to find a CDMO with the experience and license approvals to handle controlled substance APIs.
Cambrex is one of the few companies licensed to import narcotic raw materials at commercial scale. Our experienced team has expertise in manufacturing highly potent opioids for pain management, addiction treatment, obesity control, neurostimulants, ADHD and benzodiazepines. We hold US Drug Enforcement Agency (DEA) licenses for process research, development, manufacturing and importation of Schedule II to IV controlled substances, and we have been successfully manufacturing highly potent opioids since 2005. Cambrex maintains Drug Master Files (DMF) for more than 20 controlled substance APIs.
During controlled substance manufacturing, 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.
- Highly secure, controlled access to development and production suites, waste management systems and 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 and Safety
- Highly regimented safety protocols and PPE requirements
- Personnel experienced in handling controlled substances and hazardous materials
- Highly controlled document protocols and procedures
Highly 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)