Navinta LLC Seeks Approval to Bulk Manufacture Powerful Remifentanil Drug
Published Date: 12/22/2025
Notice
Summary
Navinta LLC wants to become a big-time maker of a strong medicine called Remifentanil, which is tightly controlled by the government. People who already make or use this drug can share their thoughts or ask for a hearing by February 20, 2026. This move could shake up how this drug is made and shared, but no extra costs or changes are announced yet.
No Economic Impacts Identified for this Document
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-10128 — Revision of Applications for Manufacturing and Procurement Quotas
The DEA wants to update how companies apply for permission to make and buy certain controlled drugs and chemicals. These changes will make the rules clearer, help prevent drug shortages, and ensure enough supply for medical and scientific needs. If you’re a manufacturer or involved in this process, get ready to follow new steps and share your thoughts by July 20, 2026.
2026-10253 — Schedules of Controlled Substances: Temporary Placement of 2-Fluorodeschloroketamine in Schedule I
Starting May 22, 2026, the DEA is putting 2-fluorodeschloroketamine (2-FDCK) into Schedule I, meaning it’s now treated like the most dangerous drugs. This affects anyone who makes, sells, or uses it, adding strict rules and serious penalties. The temporary ban lasts two years, giving the government time to decide if it should stay permanent.
2026-10090 — Exempt Chemical Preparations Under the Controlled Substances Act
The Drug Enforcement Administration (DEA) reviewed and decided on applications for special chemical mixtures that don’t fall under strict drug rules, covering requests from July 2025 to March 2026. Some mixtures got approved, others denied, and a few listings were fixed from earlier notices. If you’re involved with these chemicals, you’ve got until July 20, 2026, to share your thoughts—no fees or big costs involved, just your voice!
2026-09566 — Schedules of Controlled Substances: Placement of CUMYL-PEGACLONE in Schedule I
Starting May 13, 2026, the DEA officially puts CUMYL-PEGACLONE—a chemical that can be risky—into Schedule I, the strictest drug category. This means anyone making, selling, or using it now faces tough rules and penalties. This move helps the U.S. follow international drug laws and keeps communities safer without any new fees or costs.
2026-08587 — Importer of Controlled Substances Application: ANI Pharmaceuticals Inc.
ANI Pharmaceuticals wants to import certain controlled drugs like Levorphanol and Tapentadol. People who make or use these drugs can share their thoughts or ask for a hearing by June 3, 2026. This move could affect drug availability and regulation, so keep an eye on the deadline to have your say!
2026-08588 — Bulk Manufacturer of Controlled Substances Application: Patheon API Inc.
Patheon API Inc. wants to make large amounts of special research drugs like dimethyltryptamine and psilocybin. This affects researchers and companies involved in clinical trials, with a chance to comment or ask for a hearing by July 6, 2026. No money changes are mentioned, but this move could speed up important medical studies.
Previous / Next Documents
Previous: 2025-23619 — Importer of Controlled Substances Application: Myonex LLC
Myonex LLC wants to become an official importer of certain controlled drugs like amphetamine and methylphenidate. People and companies involved with these drugs can share their thoughts or ask for a hearing by January 21, 2026. This move could affect how these medicines enter the U.S., but no costs or changes to users are mentioned yet.
Next: 2025-23621 — Bulk Manufacturer of Controlled Substances Application: IsoSciences, LLC
IsoSciences, LLC wants to become a big-time maker of some powerful controlled substances like LSD and marijuana. This means they’ll handle these drugs in large amounts, which could impact research and medicine. People have until February 20, 2026, to share their thoughts or ask for a hearing, so the clock is ticking!