Manufacturer of Controlled Substances; Notice of Application; Cambrex Charles City, Inc., 43863 [2012-18212]

Download as PDF 43863 Federal Register / Vol. 77, No. 144 / Thursday, July 26, 2012 / Notices (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than September 24, 2012. Dated: July 17, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2012–18203 Filed 7–25–12; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Dated: July 17, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Cambrex Charles City, Inc. [FR Doc. 2012–18212 Filed 7–25–12; 8:45 am] BILLING CODE 4410–09–P Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 4, 2012, Cambrex Charles City, Inc., 1205 11th Street, Charles City, Iowa 50616, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: Drug Schedule TKELLEY on DSK3SPTVN1PROD with NOTICES Gamma Hydroxybutyric Acid (2010). Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ 4-Anilino-N-phenethyl-4-piperidine (ANPP)(8333). Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Methadone (9250) ........................ Dextropropoxyphene, bulk (nondosage forms) (9273). Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Opium, raw (9600) ....................... Opium extracts (9610) .................. Opium fluid extract (9620) ............ Opium tincture (9630) .................. Opium, powdered (9639) ............. Opium, granulated (9640) ............ Oxymorphone (9652) ................... Noroxymorphone (9668) .............. Poppy Straw Concentrate (9670) Alfentanil (9737) ........................... Remifentanil (9739) ...................... Sufentanil (9740) .......................... Fentanyl (9801) ............................ I II II II II II II II II II II II II 16:42 Jul 25, 2012 Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Boehringer Ingelheim Chemicals Inc. Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on June 8, 2012, Boehringer Ingelheim Chemicals Inc., 2820 N. Normandy Drive, Petersburg, Virginia 23805–9372, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: Schedule Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Methadone (9250) ........................ Methadone Intermediate (9254) ... Tapentadol (9780) ........................ II II II II II II II II II II II II II II II II Jkt 226001 DEPARTMENT OF JUSTICE Drug 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. Any other such applicant, and any person who is presently registered with VerDate Mar<15>2010 DEA to manufacture such substances, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than September 24, 2012. II II II II II II The company plans to manufacture the listed controlled substances in bulk for sale to its customers for formulation into finished pharmaceuticals. In reference to Methadone Intermediate (9254) the company plans to produce Methadone HCL active pharmaceutical ingredients (APIs) for sale to its customers. Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, PO 00000 Frm 00059 Fmt 4703 Sfmt 9990 Springfield, Virginia 22152; and must be filed no later than September 24, 2012. Dated: July 17, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration [FR Doc. 2012–18202 Filed 7–25–12; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration, Cambrex Charles City, Inc. By Notice dated April 17, 2012 and published in the Federal Register on April 26, 2012, 77 FR 24986, Cambrex Charles City, Inc., 1205 11th Street, Charles City, Iowa 50616, made application by letter to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: Drug Hydrocodone (9193) ..................... Methadone (9250) ........................ Schedule II II The company plans to manufacture the listed controlled substances in bulk for sale to its customers. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a), and determined that the registration of Cambrex Charles City, Inc. to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Cambrex Charles City, Inc. to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems, verification of the company’s compliance with state and local laws, and a review of 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. Dated: July 17, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2012–18209 Filed 7–25–12; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\26JYN1.SGM 26JYN1

Agencies

[Federal Register Volume 77, Number 144 (Thursday, July 26, 2012)]
[Notices]
[Page 43863]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18212]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application; 
Cambrex Charles City, Inc.

    Pursuant to Sec.  1301.33(a), Title 21 of the Code of Federal 
Regulations (CFR), this is notice that on May 4, 2012, Cambrex Charles 
City, Inc., 1205 11th Street, Charles City, Iowa 50616, made 
application by renewal to the Drug Enforcement Administration (DEA) to 
be registered as a bulk manufacturer of the following basic classes of 
controlled substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)...........  I
Amphetamine (1100).........................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
4-Anilino-N-phenethyl-4-piperidine           II
 (ANPP)(8333).
Phenylacetone (8501).......................  II
Cocaine (9041).............................  II
Codeine (9050).............................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Methadone (9250)...........................  II
Dextropropoxyphene, bulk (non-dosage forms)  II
 (9273).
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.
    Any other such applicant, and any person who is presently 
registered with DEA to manufacture such substances, may file comments 
or objections to the issuance of the proposed registration pursuant to 
21 CFR 1301.33(a).
    Any such written comments or objections should be addressed, in 
quintuplicate, to the Drug Enforcement Administration, Office of 
Diversion Control, Federal Register Representative (ODL), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than September 24, 2012.

    Dated: July 17, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2012-18212 Filed 7-25-12; 8:45 am]
BILLING CODE 4410-09-P
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