Opportunity
Federal Register #DEA1711
DEA Registration Applications for Bulk Manufacturing and Import of Controlled Substances by ANI Pharmaceuticals and Patheon
Buyer
Drug Enforcement Administration
Posted
May 04, 2026
Respond By
July 06, 2026
Identifier
DEA1711
NAICS
325412, 325411
This notice details applications to the Drug Enforcement Administration (DEA) for registration as importers and bulk manufacturers of controlled substances for research, clinical trials, and commercial drug development:
Government Buyer
- Department of Justice, Drug Enforcement Administration (DEA)
OEMs and Vendors
- ANI Pharmaceuticals Inc.
- Patheon API Inc.
- Patheon Pharmaceuticals Inc.
Products/Controlled Substances Requested
- Levorphanol (part number 9220, Schedule II)
- For import and bulk manufacturing for development and commercial drug product use
- Tapentadol (part number 9780, Schedule II)
- Imported in small quantities for internal research and reference standards
- Dimethyltryptamine (part number 7435, Schedule I)
- Bulk manufactured for research and clinical trials
- Psilocybin (part number 7437, Schedule I)
- Bulk manufactured for research and clinical trials
- Psilocyn (part number 7438, Schedule I)
- Bulk manufactured for research and clinical trials
- Gamma Hydroxybutyric Acid (part number 2010, Schedule I)
- Bulk manufactured as an Active Pharmaceutical Ingredient for further synthesis into FDA-approved dosage forms
Unique or Notable Requirements
- Registrations are strictly for research, clinical trials, internal research, and development of commercial drug products
- No authorization for import or manufacture of finished dosage forms for commercial sale unless specified
- Public comments and hearing requests are invited regarding these registrations
Applicant Facility Locations
- 70 Lake Drive, East Windsor, NJ 08520
- 6173 East Old Marion Highway, Florence, SC 29506
- 2110 East Galbraith Road, Cincinnati, OH 45237
Description
ANI Pharmaceuticals Inc. has applied to be registered as a bulk manufacturer of basic classes of controlled substances. The application includes the manufacture of Levorphanol (Schedule II) for development and eventual use in a commercial drug product. Comments and objections to the proposed registration can be submitted electronically or in writing on or before July 6, 2026. Interested parties may also request a hearing by the same date.