# 2026-22556: Company Seeks Federal Approval to Manufacture Controlled Painkiller

2026-22556, Bulk Manufacturer of Controlled Substances Application: Navinta LLC, is a Federal Register notice from Justice Department, Drug Enforcement Administration published 2026-11-05, effective Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before January 4, 2027. Such persons may also file a written request for a hearing on the application on or before January 4, 2027. (as of 2026-11-06).

- Canonical: https://policyrisk.com/federal-register/2026-22556
- As of: 2026-11-06
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-22556
- Title: Bulk Manufacturer of Controlled Substances Application: Navinta LLC
- Type: Notice
- Agencies: Justice Department; Drug Enforcement Administration
- Citation: 91 FR 69885
- Published: 2026-11-05
- Effective: Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before January 4, 2027. Such persons may also file a written request for a hearing on the application on or before January 4, 2027.
- Comments close: 2027-01-04
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-11-06

## In one line

Company Seeks Federal Approval to Manufacture Controlled Painkiller

## Summary

Navinta LLC wants to become a big-time maker of a strong medicine called Remifentanil, which is tightly controlled by the government. People and companies involved with this drug can share their thoughts or ask for a hearing by January 4, 2027. This move could affect how this medicine is made and shared, but no extra activities are allowed beyond manufacturing.

## Abstract

Navinta LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

## Effects PRIA read

No economic effects identified for this document.

## Related documents

- [2026-11526](https://policyrisk.com/federal-register/2026-11526): Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 201…, 2026-06-09
- [2026-10128](https://policyrisk.com/federal-register/2026-10128): Revision of Applications for Manufacturing and Procurement Quotas, 2026-05-20
- [2025-05007](https://policyrisk.com/federal-register/2025-05007): Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients, 2025-03-24
- [2025-02793](https://policyrisk.com/federal-register/2025-02793): Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients, 2025-02-19
- [2026-22553](https://policyrisk.com/federal-register/2026-22553): Importer of Controlled Substances Application: Noramco, 2026-11-05
- [2026-22555](https://policyrisk.com/federal-register/2026-22555): Importer of Controlled Substances Application: Diamond Animal Health, Inc., 2026-11-05

## Sources
- [2026-22556 on federalregister.gov](https://www.federalregister.gov/documents/2026/11/05/2026-22556/bulk-manufacturer-of-controlled-substances-application-navinta-llc)
- [2026-22556 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-11-05/pdf/2026-22556.pdf)

## Related
- [Previous: 2026-22555, Importer of Controlled Substances Application: Diamond Animal Health, Inc.](https://policyrisk.com/federal-register/2026-22555)
- [Next: 2026-22557, Proposed Information Collection Activity; Information Comparison With Insurance…](https://policyrisk.com/federal-register/2026-22557)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-22556 (as of 2026-11-06).