Federal Register #2026-17387

DEA Bulk Manufacturer and Importer Registration Application – Cambrex Charles City

This notice concerns Cambrex Charles City's application to the Drug Enforcement Administration (DEA) for registration as a bulk manufacturer and importer of controlled substances. - Government Buyer: - Drug Enforcement Administration (DEA), U.S. Department of Justice - OEM/Vendor: - Cambrex Charles City (applicant for registration) - Products/Services Requested: - Bulk manufacture and import of multiple controlled substances, including: - Gamma Hydroxybutyric Acid (part number 2010) - Synthetic Tetrahydrocannabinols (part number 7370) - Amphetamine (part number 1100) - Lisdexamfetamine (part number 1205) - Methylphenidate (part number 1724) - ANPP (4-Anilino-N-phenethyl-4-piperidine) (part number 8333) - Phenylacetone (part number 8501) - Codeine (part number 9050) - Oxycodone (part number 9143) - Hydromorphone (part number 9150) - Hydrocodone (part number 9193) - Methadone (part number 9250) - Morphine (part number 9300) - Oripavine (part number 9330) - Thebaine (part number 9333) - Opium extracts (part number 9610) - Opium fluid extract (part number 9620) - Opium tincture (part number 9630) - Opium, powdered (part number 9639) - Oxymorphone (part number 9652) - Noroxymorphone (part number 9668) - Fentanyl (part number 9801) - Psilocybin (part number 7437) - Coca Leaves (part number 9040) - Opium Raw (part number 9600) - Poppy Straw Concentrate (part number 9670) - Unique/Notable Requirements: - Registration is for bulk manufacture and import only, not for other activities - Substances will be used for conversion, dosage form development, clinical trials, and stability qualification studies - Synthetic Tetrahydrocannabinols are limited to synthetic bulk manufacturing - Psilocybin, Coca Leaves, Opium Raw, and Poppy Straw Concentrate are specifically for import to support further manufacturing - DEA is accepting electronic comments and hearing requests regarding this application

Description

Cambrex Charles City has applied to be registered as a bulk manufacturer of various basic classes of controlled substances. The company plans to manufacture these substances in bulk for conversion to other controlled substances and sales to customers for dosage form development, clinical trials, and stability qualification studies. The application includes a list of controlled substances with their drug codes and schedules. Comments and requests for hearings on the application are accepted until October 26, 2026.

View original listing