[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Notices]
[Page 61074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24543]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-539]


Bulk Manufacturer of Controlled Substances Application: Cambrex 
Charles City

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before January 13, 2020.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this 
is notice that on May 15, 2019, Cambrex Charles City, 1205 11th Street, 
Charles City, Iowa 50616-3466 applied to be registered as a bulk 
manufacturer of the following basic classes of controlled substances:

------------------------------------------------------------------------
         Controlled substance           Drug code         Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid............        2010  I
Amphetamine..........................        1100  II
Lisdexamfetamine.....................        1205  II
Methylphenidate......................        1724  II
ANPP (4-Anilino-N-phenethyl-4-               8333  II
 piperidine).
Phenylacetone........................        8501  II
Cocaine..............................        9041  II
Codeine..............................        9050  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
Oxymorphone..........................        9652  II
Noroxymorphone.......................        9668  II
Fentanyl.............................        9801  II
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    The company plans to manufacture the listed controlled substances 
in bulk for conversion to other controlled substances and sale to its 
customers, for dosage form development, for clinical trials, and for 
use in stability qualification studies.

    Dated: October 30, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-24543 Filed 11-8-19; 8:45 am]
 BILLING CODE 4410-09-P