2025-02740NoticeWallet

Janssen Ramps Up Ritalin and Opioid Production

Published Date: 2/18/2025

Notice

Summary

Janssen Pharmaceuticals wants to officially make big batches of three strong medicines: Methylphenidate, Hydromorphone, and Tapentadol. This move affects drug makers and users by ensuring these drugs are made safely and legally. People can share their thoughts or ask for a hearing by April 21, 2025, so don’t miss the deadline!

Analyzed Economic Effects

1 provisions identified: 1 benefits, 0 costs, 0 mixed.

Janssen Seeks Bulk Manufacturer Registration

Janssen Pharmaceuticals applied on December 4, 2024 to be registered as a bulk manufacturer of three Schedule II controlled substances: Methylphenidate (code 1724), Hydromorphone (code 9150), and Tapentadol (code 9780). The company plans to bulk manufacture these substances as internal-use intermediates for sale to its customers, and the application is open for comments or hearing requests through April 21, 2025.

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Key Dates

Published Date
2/18/2025

Department and Agencies

Department
Independent Agency
Agency
Justice Department
Drug Enforcement Administration
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