Cambrex Charles City Applies to Import Controlled Substances
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Cambrex Charles City, located at 1205 11th Street, Charles City, Iowa, has applied to become an importer of controlled substances. The application was submitted on June 23, 2025.
The company seeks permission to import several basic classes of controlled substances. These substances and their details are:
- Psilocybin (Drug code: 7437, Schedule I)
- 4-Anilino-N-phenethyl-4-piperidine (ANPP) (Drug code: 8333, Schedule II)
- Phenylacetone (Drug code: 8501, Schedule II)
- Coca Leaves (Drug code: 9040, Schedule II)
- Opium Raw (Drug code: 9600, Schedule II)
- Poppy Straw Concentrate (Drug code: 9670, Schedule II)
Cambrex Charles City plans to import psilocybin for formulation development and to support clinical trials for customers. The other substances will be imported to help make other controlled substances. These controlled substances will then be sent to customers.
No other uses for these drug codes are allowed under this registration. The Drug Enforcement Administration (DEA) will only approve permits if the company’s business matches what is allowed under 21 U.S.C. 952(a)(2). The registration does not allow importing finished dosage forms, whether approved or not by the Food and Drug Administration, for commercial sale.
Registered bulk manufacturers and applicants can submit comments or objections to the DEA about this proposed registration. Comments must be sent electronically through the Federal eRulemaking Portal at https://www.regulations.gov. The deadline for submitting comments or requesting a hearing is September 22, 2025.
Requests for hearings must be sent to the Drug Enforcement Administration at the following addresses:
- Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152.
- DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
Requests should also be sent to the DEA Administrator at the same address.
This notice was made by Justin Wood, Acting Deputy Assistant Administrator, and appeared in the Federal Register on August 21, 2025.
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