Federal Register #DEA1759

DEA Notice: Bulk Manufacturer Registration Application for Oxymorphone and Noroxymorphone by Cambrex High Point, Inc.

This notice from the Drug Enforcement Administration (DEA) announces Cambrex High Point, Inc.'s application to become a registered bulk manufacturer of two Schedule II controlled substances. - Government Buyer: - Drug Enforcement Administration (DEA), U.S. Department of Justice - OEMs and Vendors: - Cambrex High Point, Inc. (applicant and proposed manufacturer) - DEA (regulatory authority) - Products/Services Requested: - Bulk manufacturing registration for Oxymorphone (drug code 9652) - Bulk manufacturing registration for Noroxymorphone (drug code 9668) - No specific quantities or part numbers provided - Unique or Notable Requirements: - Registration is for manufacturing in bulk for internal intermediates and customer distribution - Only manufacturing activities for these drug codes are authorized; no other activities permitted - DEA invites comments, objections, or hearing requests from other registered manufacturers and applicants - No physical procurement or purchase quantities; this is a regulatory registration opportunity

Description

Cambrex High Point, Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). The company plans to manufacture controlled substances Oxymorphone and Noroxymorphone in bulk for use as internal intermediates and distribution to its customers. Registered bulk manufacturers and applicants may submit electronic comments or objections to the issuance of the proposed registration by November 13, 2026. Written requests for a hearing on the application are also due by November 13, 2026.

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