Bulk Manufacturer of Controlled Substances Application: Noramco

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Published

October 31, 2022

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

Noramco 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.

Full Text

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<title>Federal Register, Volume 87 Issue 209 (Monday, October 31, 2022)</title>
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[Federal Register Volume 87, Number 209 (Monday, October 31, 2022)]
[Notices]
[Page 65608]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-23614]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1109]


Bulk Manufacturer of Controlled Substances Application: Noramco

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Noramco 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 
December 30, 2022. Such persons may also file a written request for a 
hearing on the application on or before December 30, 2022.

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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 29, 2022, Noramco, 500 Swedes Landing Road, 
Wilmington, Delaware 19801-4417, applied to be registered as a bulk 
manufacturer of the following basic class(es) of controlled 
substance(s):

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid..............     2010  I
Marihuana..............................     7360  I
Tetrahydrocannabinols..................     7370  I
Codeine-N-oxide........................     9053  I
Dihydromorphine........................     9145  I
Hydromorphinol.........................     9301  I
Morphine-N-oxide.......................     9307  I
Amphetamine............................     1100  II
Lisdexamfetamine.......................     1205  II
Methylphenidate........................     1724  II
Nabilone...............................     7379  II
Phenylacetone..........................     8501  II
Codeine................................     9050  II
Dihydrocodeine.........................     9120  II
Oxycodone..............................     9143  II
Hydromorphone..........................     9150  II
Hydrocodone............................     9193  II
Morphine...............................     9300  II
Oripavine..............................     9330  II
Thebaine...............................     9333  II
Opium extracts.........................     9610  II
Opium fluid extract....................     9620  II
Opium, tincture........................     9630  II
Opium, powdered........................     9639  II
Opium, granulated......................     9640  II
Oxymorphone............................     9652  II
Noroxymorphone.........................     9668  II
Tapentadol.............................     9780  II
------------------------------------------------------------------------

    The company plans to bulk manufacture the listed controlled 
substances as an Active Pharmaceutical Ingredient (API) for supply to 
its customers. In reference to drug codes 7360 (Marihuana), and 7370 
(Tetrahydrocannabinols), the company plans to bulk manufacture these 
drugs as synthetic. No other activities for these drug codes are 
authorized for this registration.

Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-23614 Filed 10-28-22; 8:45 am]
BILLING CODE 4410-09-P


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