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Notice

Manufacturer of Controlled Substances Registration: Cambrex Charles City

Document Details

Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

ACTION:

Notice of registration.

SUMMARY:

Cambrex Charles City applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cambrex Charles City registration as a manufacturer of those controlled substances.

End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

By notice dated April 14, 2015, and published in the Federal Register on April 22, 2015, 80 FR 22555, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice.

The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Cambrex Charles City to manufacture the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and Start Printed Page 46337local laws, and reviewing the company's background and history.

Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed:

Controlled substanceSchedule
Amphetamine (1100)II
Lisdexamfetamine (1205)II
Methylphenidate (1724)II
4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333)II
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, raw (9600)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
Poppy Straw Concentrate (9670)II
Alfentanil (9737)II
Remifentanil (9739)II
Sufentanil (9740)II
Fentanyl (9801)II

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

Start Signature

Dated: July 29, 2015.

Joseph T. Rannazzisi,

Deputy Assistant Administrator.

End Signature End Supplemental Information

[FR Doc. 2015-19111 Filed 8-3-15; 8:45 am]

BILLING CODE 4410-09-P