# 2025-15162: Biopharma Firm Applies to Produce Large Quantities of Controlled Meds

2025-15162, Bulk Manufacturer of Controlled Substances Application: Biopharmaceutical Research Company, is a Federal Register notice from Justice Department, Drug Enforcement Administration published 2025-08-11 (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-15162
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-15162
- Title: Bulk Manufacturer of Controlled Substances Application: Biopharmaceutical Research Company
- Type: Notice
- Agencies: Justice Department; Drug Enforcement Administration
- Citation: 90 FR 38668
- Published: 2025-08-11
- Effective: unknown
- Comments close: not stated
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

Biopharma Firm Applies to Produce Large Quantities of Controlled Meds

## Summary

Biopharmaceutical Research Company wants to get official approval to make large amounts of certain controlled substances. This affects anyone tracking or regulating these drugs and could speed up research and development. Keep an eye out for updates on approval timing and any related fees.

## Abstract

Biopharmaceutical Research Company 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

- Application to Bulk-Manufacture Controlled Drugs: mixed, low. Biopharmaceutical Research Company has applied to be registered as a bulk manufacturer of basic classes of controlled substances. This affects people and organizations that track or regulate these drugs and could speed up research and development.
- Watch for Approval Timing and Fees: cost, low. The notice advises stakeholders to watch for updates on approval timing and any related fees. If you are an applicant, regulator, or otherwise involved with these drugs, future notices may announce when approval happens and whether fees apply.

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## Sources
- [2025-15162 on federalregister.gov](https://www.federalregister.gov/documents/2025/08/11/2025-15162/bulk-manufacturer-of-controlled-substances-application-biopharmaceutical-research-company)
- [2025-15162 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-08-11/pdf/2025-15162.pdf)

## Related
- [Previous: 2025-15161, Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals](https://policyrisk.com/federal-register/2025-15161)
- [Next: 2025-15164, Notice of Public Hearing and Request for Comments on the Fair Market Value and…](https://policyrisk.com/federal-register/2025-15164)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-15162 (as of 2026-06-08).