GMP Controlled Substance
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
- Dedicated aseptic fill and finish facility licensed to handle Schedule III, IIIN, IV and V controlled substances
- 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
