[Federal Register Volume 88, Number 62 (Friday, March 31, 2023)]
[Notices]
[Page 19327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06700]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1173]


Bulk Manufacturer of Controlled Substances Application: ANI 
Pharmaceuticals, Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: ANI 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 
May 30, 2023. Such persons may also file a written request for a 
hearing on the application on or before May 30, 2023.

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 March 3, 2023, ANI Pharmaceuticals, Inc., 70 Lake 
Drive, East Windsor, New Jersey 08520, applied to be registered as a 
bulk manufacturer of the following basic class(es) of controlled 
substance(s):

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                                           Drug
          Controlled substance             code          Schedule
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Psilocybin.............................     7437  I
Levorphanol............................     9220  I
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    The company plans to bulk manufacture the listed controlled 
substances for the internal use or for sale to its customers. No other 
activities for these drug codes are authorized for this registration.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-06700 Filed 3-30-23; 8:45 am]
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