Controlled Substances

Managing Risk in a Highly Regulated Environment

Managing the regulations involving controlled substance manufacturing requires specialized expertise that many small and medium life science companies do not have. Purisys is licensed for the handling of Class I to Class V controlled substances for research, manufacturing, analytical testing, importation, exportation, and distribution. We have decades of experience in manufacturing controlled substance API manufacturing in DEA- and FDA-inspected US-based facilities, and maintenance of multiple Drug Master Files (DMFs).

When manufacturing controlled substances, Purisys utilizes specialized facilities and has installed a number of high-tech, dual-authentication security and laboratory controls to ensure the safe handling of controlled substance APIs.

As a leading global producer of controlled APIs, reference standards and starting materials, Purisys works cooperatively and interactively with regulatory agencies and advisory boards throughout the world to prevent product diversion and to ensure that appropriate systems are in place to comply with the laws of individual countries and their quota-order monitoring requirements.

Purisys strives to not only meet–but consistently exceed–the controlled substance handling requirements promulgated by the regulatory agencies of various countries and international organizations, including:

  • INCB (International Narcotics Control Board)
  • U.S. Drug Enforcement Administration
  • State Drug Control Boards

To learn more about our CDMO services, visit our CDMO page. If you would like to connect with us to find out more about our offerings, email us at

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