[Federal Register Volume 88, Number 161 (Tuesday, August 22, 2023)]
[Notices]
[Pages 57131-57132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18043]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1247]


Bulk Manufacturer of Controlled Substances Application: Cambrex 
Charles City

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

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SUMMARY: Cambrex Charles City 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 
October 23, 2023. Such persons may also file a written request for a 
hearing on the application on or before October 23, 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 July 3, 2023, Cambrex Charles City, 1205 11th Street, 
Charles City, Iowa 50616-3466, applied to be registered as a bulk 
manufacturer of the following basic class(es) of controlled 
substance(s):

[[Page 57132]]



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                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid..............     2010  I
Tetrahydrocannabinols..................     7370  I
Amphetamine............................     1100  II
Lisdexamfetamine.......................     1205  II
Methylphenidate........................     1724  II
ANPP (4-Anilino-N-phenethyl-4-              8333  II
 piperidine).
Phenylacetone..........................     8501  II
Codeine................................     9050  II
Oxycodone..............................     9143  II
Hydromorphone..........................     9150  II
Hydrocodone............................     9193  II
Methadone..............................     9250  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
Oxymorphone............................     9652  II
Noroxymorphone.........................     9668  II
Fentanyl...............................     9801  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk for conversion to other controlled substances and sales to its 
customers for dosage form development, clinical trials and use in 
stability qualification studies.
    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.

Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-18043 Filed 8-21-23; 8:45 am]
BILLING CODE P