Controlled Substances

Controlled substances are a class of raw materials, intermediates, APIs and finished drugs highly regulated by the FDA, DEA, EMEA and other regulatory agencies throughout the world. From the importation of raw materials, to manufacture and distribution, Cambrex has the licenses and facility controls in place to safely and effectively develop, manufacture, distribute and store controlled substances.

At Cambrex, we provide assurance and peace of mind when manufacturing controlled substance APIs for our clients

• Our production facilities routinely ship grams to commercial quantities of Schedule II - IV controlled substances throughout the world
• Each site possesses the required licenses and has the necessary security, inventory controls and facilities in place to meet worldwide regulatory requirements
• Since 2002, we have had DEA licensure for the process research, development, manufacture and importation of Schedule II - IV controlled substances
• Cambrex holds Drug Master Files for over 20 controlled substances
• We have been manufacturing highly potent opioids since 2005
• Cambrex is one of a limited number of companies authorized by the DEA to import narcotic raw materials at commercial scale
• Our controlled substance programs are overseen by an onsite Controlled Substance Officer/DEA Regulatory Specialist