This PDF is the current document as it appeared on Public Inspection on 08/03/2015 at 08:45 am.
Notice of registration.
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
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:
|4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333)||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|
|Poppy Straw Concentrate (9670)||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.
[FR Doc. 2015-19111 Filed 8-3-15; 8:45 am]
BILLING CODE 4410-09-P