Bulk Manufacturer of Controlled Substances Application: ANI Pharmaceuticals, Inc., 19327 [2023-06700]

Download as PDF 19327 Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices The company plans to bulk manufacture the listed controlled substances for the production of active pharmaceutical ingredients (API) and analytical reference standards for sale to its customers. The company plans to manufacture the above listed controlled substances as clinical trial and starting materials to make compounds for distribution to its customers. No other activities for these drug codes are authorized for this registration. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–06687 Filed 3–30–23; 8:45 am] BILLING CODE P Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this is notice that on February 22, 2023, PerkinElmer, Inc., 120 East Dedham Street, Boston, Massachusetts 02118– 2852, applied to be registered as an importer of the following basic class(es) of controlled substance(s): DEPARTMENT OF JUSTICE Controlled substance Drug Enforcement Administration Lysergic Acid Diethylamide. Thebaine ....................... [Docket No. DEA–1167] Importer of Controlled Substances Application: PerkinElmer, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: PerkinElmer, Inc. has applied to be registered as an importer 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 1, 2023. Such persons may also file a written request for a hearing on the application on or before May 1, 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. All requests for a hearing must be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:54 Mar 30, 2023 Jkt 259001 Drug code Schedule 7315 I 9333 II The company plans to import the listed controlled substances for bulk manufacturing into radioactive formulations for sale to its customers for research purposes. Drug code 9333 (Thebaine) will be used to import the Thebaine derivative Diprenorphine. No other activity for this drug code is authorized for this registration. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or nonapproved finished dosage forms for commercial sale. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2023–06696 Filed 3–30–23; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration 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): DATES: Controlled substance Psilocybin ..................... Levorphanol .................. Drug code 7437 9220 Schedule I I 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] [Docket No. DEA–1173] BILLING CODE P Bulk Manufacturer of Controlled Substances Application: ANI Pharmaceuticals, Inc. DEPARTMENT OF JUSTICE Drug Enforcement Administration, Justice. ACTION: Notice of application. Drug Enforcement Administration 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. Importer of Controlled Substances Application: Lyndra Therapeutics AGENCY: SUMMARY: PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 [Docket No. DEA–1165] Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: E:\FR\FM\31MRN1.SGM 31MRN1

Agencies

[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):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Psilocybin.............................     7437  I
Levorphanol............................     9220  I
------------------------------------------------------------------------

    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]
BILLING CODE P
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