Manufacturer of Controlled Substances; Notice of Registration; Siegfried (USA), 30027-30028 [2012-12274]

Download as PDF Federal Register / Vol. 77, No. 98 / Monday, May 21, 2012 / Notices 30027 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 July 20, 2012. Schedule manufacturer of Tapentadol (9780), a basic class of controlled substance listed in schedule II. The company plans to manufacture the listed controlled substance for sale to its customers. Any other such applicant, and any person who is presently registered with DEA to manufacture such substance, 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 July 20, 2012. Dated: May 9, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Austin Pharma, LLC. Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on April 11, 2012, Austin Pharma, LLC., 811 Paloma Drive, Suite C, Round Rock, Texas 78665– 2402, 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 ebenthall on DSK5SPTVN1PROD with NOTICES I I The company plans to manufacture bulk active pharmaceutical ingredients (APIs) for distribution to its customers. In reference to drug code 7360 (Marihuana), the company plans to bulk manufacture cannabidiol as a synthetic intermediate. This controlled substance will be further synthesized to bulk manufacture a synthetic THC (7370). No other activity for this drug code is authorized for this registration. Any other such applicant, and any person who is presently registered with DEA to manufacture such substance, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR 1301.33(a). VerDate Mar<15>2010 19:32 May 18, 2012 Jkt 226001 BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on March 15, 2012, American Radiolabeled Chemicals, Inc., 101 Arc Drive, St. Louis, Missouri 63146, 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: BILLING CODE 4410–09–P Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... [FR Doc. 2012–12280 Filed 5–18–12; 8:45 am] Manufacturer of Controlled Substances; Notice of Application; American Radiolabeled Chemicals, Inc. [FR Doc. 2012–12284 Filed 5–18–12; 8:45 am] Drug Dated: May 9, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Drug Schedule Gamma Hydroxybutyric Acid (2010). Ibogaine (7260) ............................ Lysergic acid diethylamide (7315) Tetrahydrocannabinols (7370) ..... Dimethyltryptamine (7435) ........... 1-[1-(2Thienyl)cyclohexyl]piperidine (7470). Dihydromorphine (9145) ............... Normorphine (9313) ..................... Heroin (9200) ............................... Amphetamine (1100) .................... Methamphetamine (1105) ............ Amobarbital (2125) ....................... Phencyclidine (7471) .................... Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Ecgonine (9180) ........................... Hydrocodone (9193) ..................... Meperidine (9230) ........................ Metazocine (9240) ........................ Dextropropoxyphene, bulk (nondosage forms) (9273). Morphine (9300) ........................... Oripavine (9330) ........................... Thebaine (9333) ........................... Oxymorphone (9652) ................... Phenazocine (9715) ..................... Carfentanil (9743) ......................... PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 I I I I I I I I I II II II II II II II II II II II II II II II II II II II II II Drug Fentanyl (9801) ............................ II The company plans to manufacture small quantities of the listed controlled substances as radiolabeled compounds for biochemical research. 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 July 20, 2012. Dated: May 9, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2012–12251 Filed 5–18–12; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration; Siegfried (USA) By Notice dated January 6, 2012, and published in the Federal Register on January 17, 2012, 77 FR 2323, Siegfried (USA), 33 Industrial Park Road, Pennsville, New Jersey 08070, 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 Gamma Hydroxybutyric Acid (2010). Dihydromorphine (9145) ............... Hydromorphinol (9301) ................. Methylphenidate (1724) ................ Amobarbital (2125) ....................... Pentobarbital (2270) ..................... Secobarbital (2315) ...................... Codeine (9050) ............................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Methadone (9250) ........................ Methadone intermediate (9254) ... Dextropropoxyphene, bulk (nondosage forms) (9273). Morphine (9300) ........................... Oripavine (9330) ........................... Oxymorphone (9652) ................... E:\FR\FM\21MYN1.SGM 21MYN1 Schedule I I I II II II II II II II II II II II II II II 30028 Federal Register / Vol. 77, No. 98 / Monday, May 21, 2012 / Notices The company plans to manufacture the listed controlled substances in bulk for distribution 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 Siegfried (USA), to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has investigated Siegfried (USA), 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: May 11, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. BILLING CODE 4410–09–P Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration; Cedarburg Pharmaceuticals, Inc. DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration; Cambrex Charles City, Inc. By Notice dated September 27, 2011, and published in the Federal Register on October 7, 2011, 76 FR 62449, 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 Schedule ebenthall on DSK5SPTVN1PROD with NOTICES Noroxymorphone (9668) .............. Alfentanil (9737) ........................... Remifentanil (9739) ...................... II II II The company plans to manufacture the listed controlled substance Noroxymorphone (9668), in bulk for sale to its customers. It plans to manufacture the other two listed controlled substances in bulk for dosage form development, clinical trials, and use in stability qualification studies. No comments or objections have been received. DEA has considered the Jkt 226001 By Notice dated January 6, 2012, and published in the Federal Register on January 17, 2012, 77 FR 2324, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024, 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 4-Anilino-N-phenethyl-4-piperidine (8333). Fentanyl (9801) ............................ II II The company plans to manufacture the listed controlled substances in bulk for distribution to its customers. Regarding the drug code (8333), the company plans to use this controlled substance to manufacture another controlled substance. 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 Cedarburg Pharmaceuticals, Inc. to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time. DEA has PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 investigated Cedarburg Pharmaceuticals, 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: May 11, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2012–12271 Filed 5–18–12; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration; Johnson Matthey, Inc., Pharmaceuticals Materials DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P 18:18 May 18, 2012 Dated: May 11, 2012. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2012–12275 Filed 5–18–12; 8:45 am] [FR Doc. 2012–12274 Filed 5–18–12; 8:45 am] VerDate Mar<15>2010 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. By Notice dated January 6, 2012, and published in the Federal Register on January 17, 2012, 77 FR 2324, Johnson Matthey, Inc., Pharmaceuticals Materials, 900 River Road, Conshohocken, Pennsylvania 19428, 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 Gamma Hydroxybutyric Acid (2010). Amphetamine (1100) .................... Methylphenidate (1724) ................ Codeine (9050) ............................. Oxycodone (9143) ........................ Hydrocodone (9193) ..................... Morphine (9300) ........................... Thebaine (9333) ........................... Schedule I II II II II II II II The company plans to manufacture the listed controlled substances in bulk for sale to its customers. The Thebaine (9333) will also be used to manufacture other controlled substances in bulk which will also be for sale in bulk 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 Johnson Matthey Inc., Pharmaceuticals Materials to manufacture the listed basic E:\FR\FM\21MYN1.SGM 21MYN1

Agencies

[Federal Register Volume 77, Number 98 (Monday, May 21, 2012)]
[Notices]
[Pages 30027-30028]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12274]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Registration; 
Siegfried (USA)

    By Notice dated January 6, 2012, and published in the Federal 
Register on January 17, 2012, 77 FR 2323, Siegfried (USA), 33 
Industrial Park Road, Pennsville, New Jersey 08070, 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
Dihydromorphine (9145).....................  I
Hydromorphinol (9301)......................  I
Methylphenidate (1724).....................  II
Amobarbital (2125).........................  II
Pentobarbital (2270).......................  II
Secobarbital (2315)........................  II
Codeine (9050).............................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Methadone (9250)...........................  II
Methadone intermediate (9254)..............  II
Dextropropoxyphene, bulk (non-dosage forms)  II
 (9273).
Morphine (9300)............................  II
Oripavine (9330)...........................  II
Oxymorphone (9652).........................  II
------------------------------------------------------------------------


[[Page 30028]]

The company plans to manufacture the listed controlled substances in 
bulk for distribution 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 
Siegfried (USA), to manufacture the listed basic classes of controlled 
substances is consistent with the public interest at this time. DEA has 
investigated Siegfried (USA), 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 Sec.  1301.33, the 
above named company is granted registration as a bulk manufacturer of 
the basic classes of controlled substances listed.

    Dated: May 11, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2012-12274 Filed 5-18-12; 8:45 am]
BILLING CODE 4410-09-P
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