Federal Register #DEA-1722

DEA Review of Veranova, L.P. Application for Bulk Manufacture of Controlled Substances

This opportunity concerns the Drug Enforcement Administration's (DEA) review of Veranova, L.P.'s application to become a registered bulk manufacturer of a broad range of controlled substances. - Government Buyer: - Department of Justice, Drug Enforcement Administration (DEA) - OEM/Vendor: - Veranova, L.P. (applicant and manufacturer) - Products/Controlled Substances Requested: - Extensive list of controlled substances for bulk manufacture, including: - Opioids: Fentanyl, Oxycodone, Hydrocodone, Morphine, Methadone, Codeine, Hydromorphone, Oxymorphone, Noroxymorphone, Dihydrocodeine, Levorphanol, Meperidine, Tapentadol, Alfentanil, Remifentanil, Sufentanil, Thebaine, Opium tincture - Stimulants: Amphetamine, Methamphetamine, Lisdexamfetamine, Methylphenidate, Cocaine, 3,4-Methylenedioxymethamphetamine (MDMA) - Barbiturates: Amobarbital, Pentobarbital, Secobarbital, Glutethimide - Cannabinoids: Marihuana, Tetrahydrocannabinols, Dronabinol, Nabilone - Hallucinogens: Psilocybin, Phencyclidine - Precursors/Intermediates: 1-Phenylcyclohexylamine, 4-Anilino-N-phenethyl-4-piperidine (ANPP), Norfentanyl, Phenylacetone, Methadone intermediate, Ecgonine - Other: Gamma Hydroxybutyric Acid, Difenoxin, Diphenoxylate - Notable Requirements: - Registration is strictly for bulk manufacture of the listed substances - Products are intended for use as internal intermediates and for sale to customers (e.g., for analytical testing and manufacturing) - No authorization for importation of finished dosage forms for commercial sale - Public comments, objections, and hearing requests are invited regarding the application - Quantities and part numbers: - Not specified in the notice; registration covers classes of substances rather than specific quantities or SKUs

Description

Veranova, L.P. has applied to be registered as a bulk manufacturer of basic classes of controlled substances. The application includes a list of controlled substances for which the company seeks registration to manufacture in bulk for use as internal intermediates and for sale to customers. Comments and objections to the application are due by August 14, 2026, and interested parties may request a hearing by the same date. The registration does not authorize activities other than those specified for the listed drug codes.

View original listing