Manufacturer of Controlled Substances; Notice of Application; Pharmacore, Inc., 64017 [2013-25088]

Download as PDF Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Notices international treaties, conventions, or protocols in effect on May 1, 1971. DEA has investigated Watson Pharma, 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. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above named company is granted registration as an importer of the basic classes of controlled substances listed. Dated: October 10, 2013. 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; Cedarburg Pharmaceuticals, Inc. Schedule emcdonald on DSK67QTVN1PROD with NOTICES II 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 manufacture this controlled substance for commercial sale. 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 17:55 Oct 24, 2013 Jkt 232001 BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Cambrex Charles City, Inc. Drug Pursuant to § 1301.33(a), of Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 8, 2013, 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: VerDate Mar<15>2010 [FR Doc. 2013–25102 Filed 10–24–13; 8:45 am] 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 December 24, 2013. Dated: September 27, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–25091 Filed 10–24–13; 8:45 am] BILLING CODE 4410–09–P BILLING CODE 4410–09–P 4-Anilino-N-phenethyl-4-piperidine (8333). Remifentanil (9739) ...................... Fentanyl (9801) ............................ Dated: October 16, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 25, 2013, 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: [FR Doc. 2013–25094 Filed 10–24–13; 8:45 am] Drug (ODW), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than December 24, 2013. 64017 Schedule Gamma Hydroxybutyric Acid (2010). Amphetamine (1100) .................... Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ 4-Anilino-N-phenethyl-4-piperidine (8333). Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Hydrocodone (9193) ..................... Methadone (9250) ........................ 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 II II II II II II II II II II II II II II 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, PO 00000 Frm 00059 Fmt 4703 Sfmt 9990 DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Pharmacore, Inc. Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 16, 2013, PharmaCore, Inc., 4180 Mendenhall Oaks Parkway, High Point, NC 27265, made application by letter to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Noroxymorphone (9668), a basic class of controlled substance listed in schedule II. The company plans to manufacture the listed controlled substance as active pharmaceutical ingredients (API) for clinical trials. 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 (ODW), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than December 24, 2013. Dated: September 27, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–25088 Filed 10–24–13; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\25OCN1.SGM 25OCN1

Agencies

[Federal Register Volume 78, Number 207 (Friday, October 25, 2013)]
[Notices]
[Page 64017]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25088]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application; 
Pharmacore, Inc.

    Pursuant to Sec.  1301.33(a), Title 21 of the Code of Federal 
Regulations (CFR), this is notice that on May 16, 2013, PharmaCore, 
Inc., 4180 Mendenhall Oaks Parkway, High Point, NC 27265, made 
application by letter to the Drug Enforcement Administration (DEA) to 
be registered as a bulk manufacturer of Noroxymorphone (9668), a basic 
class of controlled substance listed in schedule II.
    The company plans to manufacture the listed controlled substance as 
active pharmaceutical ingredients (API) for clinical trials.
    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 (ODW), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than December 24, 2013.

    Dated: September 27, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-25088 Filed 10-24-13; 8:45 am]
BILLING CODE 4410-09-P