Controlled Substance API Development & Manufacturing

Advance your controlled substance program with specialized development, manufacturing and regulatory capabilities.


DEA-licensed cGMP development and manufacturing of Schedule I-V controlled substances, from development through commercial supply.

Collaborate with us for the safe, secure development and manufacture of DEA-controlled substances and regulated chemicals.
We offer a full range of DEA registrant capabilities, including the manufacture, development, Import, export and chemical analysis of Schedule I-V controlled substances including phenidates, amphetamine derivatives and precursors, and intermediates.

Our team is uniquely positioned to deliver advanced cGMP manufacturing services for DEA-controlled substances. Our capabilities ensure that we apply revolutionized industry best practice to manufacture the highest quality products with robust technologies and appropriate analytics to release your materials.

Capabilities

  • DEA registrations for manufacturing, research, import, export and chemical analysis of Schedule I-V controlled substances
  • DEA-licensed to import Schedule II narcotic raw materials
  • High capacity and flexibility with 2 US API manufacturing plants
  • DEA Approved Controlled substance vaults, safes, cages and DEA manufacturing areas
  • Drug classes such as cannabinoids, stimulants,  including phenidates, amphetamine derivatives, and intermediates 
  • Proven track record of regulatory compliance for scheduled drugs
  • Expert production and containment capabilities
  • Access to validated processes and established raw material sources
  • Piloting collaborative partnerships in Controlled Substance drug development, including Schedule I & II-V

Curia Network

Springfield contributes large-scale controlled substance manufacturing as well as organometallic, cryogenic and distillation chemistry in the US, complementing Frankfurt’s European capabilities.

Rensselaer manufactures highly potent and controlled APIs at commercial scale in the US, supplied by regulatory starting materials from sites like Frankfurt.