Federal Register Public Inspection — Justice Department (Antitrust, DEA)Doubao · 实盘不做把握 9/10不做原因:标的无直接敞口
北京时间·🕒 发布 20:45:00(美东 08:45)·⟳ 抓取 20:45:45·⚡ 决策 10-16 20:48:06 +2m21s·10.9 天前
强生旗下杨森申请DEA管制物质散装制造商注册（哌甲酯Schedule II），仅为例行申请公示
该文件是DEA对一份例行管制物质生产注册申请的法定公示（application notice），既非批准也非新药/新订单；产品为通用名管制原料药哌甲酯中间体，对强生（JNJ.US）这类超大盘药企的收入、利润或业务结构不具任何可量化的重大性，也不构成方向性催化，无需查行情或先例即可判定无正期望交易。
📄 原文Federal Register Public Inspection — Justice Department (Antitrust, DEA)↗ 原文
DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-1788] Bulk Manufacturer of Controlled Substances…
不做 Johnson & Johnson（强生，杨森母公司）（JNJ.US）
DEA例行注册申请公示（非批准），通用名哌甲酯仅限内部中间体用途，对强生无重大性与预期差，方向中性、无edge，不做多也不做空。
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
研究档案
结论摘要
DEA例行公示强生子公司杨森申请注册生产哌甲酯（Schedule II）散装中间体，属程序性申请而非获批，且为通用名、用途受限，对强生基本面与估值无实质影响，方向中性，不做。
🔎 新鲜度:最早出现 2026-10-16 · 扩散 low · price-in 风险 low ↗
关键理由
- 无可交易逻辑：申请公示≠注册获批，60天异议期内结果未定；即便获批，通用名哌甲酯中间体对强生体量也不构成收入或利润增量。
主要风险
- 若后续公示出现重大第三方异议或DEA否决（低概率），属个别产品线的合规事项，仍远不足以影响强生整体估值。
先例如何影响了这次决策
对本次决策的影响:确认应直接AVOID，未据此寻找或交易任何标的。
方向:不适用：DEA散装管制物质制造商注册的例行申请公示对超大盘药企母公司无证券价格影响，缺乏可交易的同类价格反应样本，也无需以先例校准。
涨幅量级:无可测量的基本面增量，不定tp/sl。
形态:不适用。
原文全文
展开原文 · 2,349 字
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1788]
Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
SUMMARY: Janssen Pharmaceuticals, Inc. has applied to be registered as a bulk manufacturer
of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below
for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es), and applicants, therefore,
may submit electronic comments on or objections to the issuance of the proposed registration on
or before [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL
REGISTER]. Such persons may also file a written request for a hearing on the application on or
before [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL
REGISTER].
ADDRESSES: The Drug Enforcement Administration requires that all comments be submitted
electronically through the Federal eRulemaking Portal, which provides the ability to type short
comments directly into the comment field on the Web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the online instructions at that
site for submitting comments. Upon submission of your comment, you will receive a Comment
Tracking Number. Please be aware that submitted comments are not instantaneously available
for public view on https://www.regulations.gov. If you have received a Comment Tracking
Number, your comment has been successfully submitted and there is no need to resubmit the
same comment.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice
that on September 9, 2026, Janssen Pharmaceuticals, Inc., 1440 Olympic Drive, Buildings 1 and
5 and 8 and 20, Athens, Georgia 30601-1645, applied to be registered as a bulk manufacturer of
the following basic class(es) of controlled substance(s):
Controlled Substance
Methylphenidate
Drug Code
Schedule
II
The company plans to manufacture the listed controlled substance for the internal use
intermediates for sale to its customers. No other activity for this drug code is authorized for this
registration.
Justin Wood,
Deputy Assistant Administrator.
[FR Doc. 2026-21369 Filed: 10/16/2026 8:45 am; Publication Date: 10/19/2026]
Drug Enforcement Administration
[Docket No. DEA-1788]
Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceuticals, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
SUMMARY: Janssen Pharmaceuticals, Inc. has applied to be registered as a bulk manufacturer
of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below
for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es), and applicants, therefore,
may submit electronic comments on or objections to the issuance of the proposed registration on
or before [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL
REGISTER]. Such persons may also file a written request for a hearing on the application on or
before [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL
REGISTER].
ADDRESSES: The Drug Enforcement Administration requires that all comments be submitted
electronically through the Federal eRulemaking Portal, which provides the ability to type short
comments directly into the comment field on the Web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the online instructions at that
site for submitting comments. Upon submission of your comment, you will receive a Comment
Tracking Number. Please be aware that submitted comments are not instantaneously available
for public view on https://www.regulations.gov. If you have received a Comment Tracking
Number, your comment has been successfully submitted and there is no need to resubmit the
same comment.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this is notice
that on September 9, 2026, Janssen Pharmaceuticals, Inc., 1440 Olympic Drive, Buildings 1 and
5 and 8 and 20, Athens, Georgia 30601-1645, applied to be registered as a bulk manufacturer of
the following basic class(es) of controlled substance(s):
Controlled Substance
Methylphenidate
Drug Code
Schedule
II
The company plans to manufacture the listed controlled substance for the internal use
intermediates for sale to its customers. No other activity for this drug code is authorized for this
registration.
Justin Wood,
Deputy Assistant Administrator.
[FR Doc. 2026-21369 Filed: 10/16/2026 8:45 am; Publication Date: 10/19/2026]
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