Controlled substances

At Cambrex, our drug product experts are ready to manufacture your controlled substances. We are experienced in the manufacture of controlled substances so you can be assured that our expertise will bring your product to market quickly and efficiently.

Both of our finished dosage facilities in Whippany, NJ, USA and Mirabel, Québec, Canada can handle and manufacture controlled substance drug products.

Controlled substances at Whippany, NJ, USA

Our Whippany facility is capable of handling CI-CV narcotics for manufacturing and testing.

The facility is fully licensed by the US Drug Enforcement Agency (DEA) to handle controlled substances. As required by the DEA, the Whippany site has the required physical security infrastructure as well as tightly controlled procedures, administrative controls, and accountability processes that are carried out by highly qualified and experienced staff. We can also assist you in coordinating quota requests with DEA, decreasing the administrative burden on your company.

State of NJ CDS

  • Manufacturer: 2, 3, 4, 5
  • Analytical: 1, 2, 3, 4, 5

DEA registrations

  • Manufacturer 1, 2, 3, 3N, 4, 5

Controlled substances at Montreal, Québec, Canada

Our Mirabel facility is fully licensed to manufacture, package and store controlled substances and precursor products up to the level 10 illicit market value for the Canadian market. We have experience in the importation, production and distribution of controlled substances and precursor chemicals for the Canadian market.

The facility has been inspected by Health Canada for Narcotic Control Regulations (NCR) which falls under the authority of the Controlled Drugs and Substances Act (CDSA), Schedule G in 2013 and 2014.

Find out more about our commercial manufacturing of controlled substances

Our experts at Montreal and Whippany specialize in multi-particulate systems including sustained and extended release narcotics including many DEA schedule CI – CV products. To get in touch with an expert, contact us.

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