Janssen Seeks Approval to Manufacture More Methylphenidate
Published Date: 10/19/2026
Notice
Summary
Janssen Pharmaceuticals wants to officially make a big batch of methylphenidate, a controlled drug, at their Georgia site. People who already make or use this drug can share their thoughts or ask for a hearing by December 18, 2026. This move could affect how the drug is produced and sold, but no extra activities are allowed beyond manufacturing for sale.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Janssen applies to make methylphenidate
On September 9, 2026, Janssen Pharmaceuticals applied to be registered as a bulk manufacturer of methylphenidate (controlled substance code 1724, Schedule II) at 1440 Olympic Drive, Buildings 1, 5, 8, and 20, Athens, Georgia 30601-1645. The company says it plans to manufacture the drug as internal use intermediates for sale to its customers. The registration would not authorize any other activity for this drug code.
Comment and hearing deadline is Dec 18, 2026
Registered bulk manufacturers of the affected class and other applicants can submit electronic comments or objections, or request a hearing, on this Janssen application on or before December 18, 2026, via https://www.regulations.gov. After you submit a comment you will receive a Comment Tracking Number showing successful submission.
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