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2019-25401. Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.

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ACTION:

Notice of application.

DATES:

Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before January 21, 2020.

ADDRESSES:

Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
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SUPPLEMENTARY INFORMATION:

In accordance with 21 CFR 1301.33(a), this is notice that on March 15, 2019, Patheon API Manufacturing, Inc., 309 Delaware Street, Greenville, South Carolina 29605 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

Controlled substance Drug code Schedule
Thebaine 9333 II
Noroxymorphone 9668 II
Gamma Hydroxybutyric Acid 2010 I
Alpha-methyltryptamine 7432 I

The company plans to bulk manufacture the listed controlled substances as an Active Pharmaceutical Ingredient for supply to its customers.
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Dated: November 5, 2019.

William T. McDermott,

Assistant Administrator.

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[FR Doc. 2019-25401 Filed 11-21-19; 8:45 am]

BILLING CODE 4410-09-P

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Document Information

Published:: 11/22/2019
Department:: Drug Enforcement Administration
Entry Type:: Notice
Action:: Notice of application.
Document Number:: 2019-25401
Dates:: Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before January 21, 2020.
Pages:: 64563-64563 (1 pages)
Docket Numbers:: Docket No. DEA-529
PDF File:: 2019-25401.pdf