Federal Register #DEA-1788

Janssen Pharmaceuticals, Inc. applies to register as a bulk manufacturer of methylphenidate

This notice concerns a regulatory registration application, not a government purchase of products or services. - Government buyer: None. The notice was issued by the U.S. Department of Justice’s Drug Enforcement Administration (DEA). - Manufacturer/applicant: Janssen Pharmaceuticals, Inc. applied to register as a bulk manufacturer of methylphenidate. - Substance: Methylphenidate, drug code 1724, Schedule II. - Janssen states it plans to manufacture the substance for internal-use intermediates for sale to its customers. The proposed registration does not authorize other activities involving this drug code. - No products or services are requested for purchase; no quantities, part numbers, contract value, or period of performance are provided.

Description

Janssen Pharmaceuticals, Inc. has applied to be registered as a bulk manufacturer of methylphenidate (drug code 1724, Schedule II). The company plans to manufacture the controlled substance for internal-use intermediates for sale to its customers. No other activity for this drug code is authorized under the proposed registration. Eligible bulk manufacturers and applicants may submit comments or objections, or request a hearing, by December 18, 2026.

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