Janssen Pharma Applies for Bulk Controlled Substance Production
Published Date: 12/19/2025
Notice
Summary
Janssen Pharmaceuticals wants to make a lot of methylphenidate, a controlled drug used to treat conditions like ADHD. They’ve applied to get official permission to do this, and anyone who has concerns can speak up by February 17, 2026. This move affects drug makers and buyers and could impact the supply of this medicine.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
Janssen Seeks Bulk Methylphenidate Registration
On November 7, 2025, Janssen Pharmaceuticals applied to be registered as a bulk manufacturer of methylphenidate (drug code 1724), listed as Schedule II. The application lists a manufacturing site at 1440 Olympic Drive, Athens, Georgia 30601-1645, and states the company plans to manufacture the substance for sale to its customers; no other activity is authorized for this registration.
Comment and Hearing Deadline: Feb 17, 2026
Registered bulk manufacturers of the affected basic class(es) and applicants may submit electronic comments or objections, and may file a written request for a hearing, on or before February 17, 2026, via the Federal eRulemaking Portal at https://www.regulations.gov. Upon submission, commenters will receive a Comment Tracking Number.
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