Bulk Manufacturer of Controlled Substances Application: Pharmaron Manufacturing Services (US) LLC
Summary
The DEA published a notice that Pharmaron Manufacturing Services (US) LLC applied on February 10, 2026 to be registered as a bulk manufacturer of Schedule II controlled substances (Oxycodone, Thebaine, Oxymorphone, and Noroxymorphone) at its facility in Coventry, Rhode Island. The company plans to produce material for clinical trials only. The public has until June 1, 2026 to submit comments or objections to the application.
What changed
Pharmaron Manufacturing Services (US) LLC submitted an application to the DEA on February 10, 2026, seeking registration as a bulk manufacturer of four Schedule II controlled substance basic classes: Oxycodone (9143), Thebaine (9333), Oxymorphone (9652), and Noroxymorphone (9668). The company is located at 498 Washington Street, Coventry, Rhode Island. This notice is issued pursuant to 21 CFR 1301.33(a). The registration would authorize bulk manufacturing specifically for producing clinical trial material—no other activities are authorized for these drug codes.
Registered bulk manufacturers of the affected basic classes and other applicants may submit electronic comments or objections to the proposed registration, or file written hearing requests, on or before June 1, 2026 via Regulations.gov under Docket No. DEA-1696. Third parties with concerns about Pharmaron's application should file comments by this deadline. There are no compliance deadlines for non-applicant entities beyond the comment period.
What to do next
- Review the drug codes and activities covered by Pharmaron's application to assess any competitive or safety concerns
- File electronic comments or objections through Regulations.gov by June 1, 2026 if your organization wishes to oppose or comment on the registration
- Confirm no overlap with your own DEA bulk manufacturer registrations for Schedule II controlled substances
Archived snapshot
Apr 1, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Notice
Bulk Manufacturer of Controlled Substances Application: Pharmaron Manufacturing Services (US) LLC
A Notice by the Drug Enforcement Administration on 04/01/2026
This document has a comment period that ends in 61 days.
(06/01/2026) View Comment InstructionsPDF
Document Details
Document Dates
- Table of Contents
- Public Comments
- Regulations.gov Data
- Sharing
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- Public Inspection Published Document: 2026-06261 (91 FR 16243) Document Headings ###### Department of Justice
Drug Enforcement Administration
- Docket No. DEA-1696 # AGENCY:
Drug Enforcement Administration, Justice.
ACTION:
Notice of application.
SUMMARY:
Pharmaron Manufacturing Services (US) 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.
DATES:
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 June 1, 2026. Such persons may also file a written request for a hearing on the application on or before June 1, 2026.
ADDRESSES:
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to https://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon submission of your comment, you will receive a Comment Tracking Number. Please be aware that submitted comments are not instantaneously available for public view on https://www.regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment.
SUPPLEMENTARY INFORMATION:
In accordance with 21 CFR 1301.33(a), this is notice that on February 10, 2026, Pharmaron Manufacturing Services (US) LLC, 498 Washington Street, Coventry, Rhode Island 02816, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
| Controlled substance | Drug
code | Schedule |
| --- | --- | --- |
| Oxycodone | 9143 | II |
| Thebaine | 9333 | II |
| Oxymorphone | 9652 | II |
| Noroxymorphone | 9668 | II |
The company plans to bulk manufacture the listed controlled substances to produce material for clinical trials. No other activities for these drug codes are authorized for this registration.
Thomas Prevoznik,
Deputy Assistant Administrator.
[FR Doc. 2026-06261 Filed 3-31-26; 8:45 am]
BILLING CODE P
Published Document: 2026-06261 (91 FR 16243)
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