Cambrex High Point, Inc. Seeks DEA Registration to Manufacture Controlled Substances

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Cambrex High Point, Inc. has applied to the Drug Enforcement Administration (DEA) for registration as a bulk manufacturer of controlled substances. This notice comes from the Federal Register, Volume 90, Issue 160, dated August 21, 2025.

The company is located at 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265-8017. They submitted their application on July 18, 2025.

Cambrex High Point, Inc. is seeking permission to manufacture two basic classes of controlled substances:

  • Oxymorphone (Drug code 9652, Schedule II)
  • Noroxymorphone (Drug code 9668, Schedule II)

The purpose of this registration is to allow Cambrex High Point, Inc. to produce these substances in bulk. The company plans to use them as internal intermediates and for distribution to its customers. No other activities are authorized under this registration for these drug codes.

Registered bulk manufacturers of the affected substances, or other applicants, can submit electronic comments or objections about the proposed registration. The deadline to submit comments or request a hearing is October 20, 2025.

Comments must be sent through the Federal eRulemaking Portal at https://www.regulations.gov. The portal allows users to type comments or attach longer files. Each submission will get a Comment Tracking Number. Comments are not immediately visible online after submission.

For more details, follow instructions available on the regulations.gov website.

The notice was issued by Justin Wood, Acting Deputy Assistant Administrator of the DEA.

[FR Doc. 2025-16003 Filed 8-20-25; 8:45 am]


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