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Notice

Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City

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ACTION:

Notice of application.

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.

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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 substanceDrug codeSchedule
Gamma Hydroxybutyric Acid2010I
Amphetamine1100II
Lisdexamfetamine1205II
Methylphenidate1724II
ANPP (4-Anilino-N-phenethyl-4-piperidine)8333II
Phenylacetone8501II
Cocaine9041II
Codeine9050II
Oxycodone9143II
Hydromorphone9150II
Hydrocodone9193II
Morphine9300II
Oripavine9330II
Thebaine9333II
Opium extracts9610II
Opium fluid extract9620II
Opium tincture9630II
Opium, powdered9639II
Oxymorphone9652II
Noroxymorphone9668II
Fentanyl9801II

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.

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Dated: October 30, 2019.

William T. McDermott,

Assistant Administrator.

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[FR Doc. 2019-24543 Filed 11-8-19; 8:45 am]

BILLING CODE 4410-09-P