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

• Published date: 22 November 2019
• Citation: 84 FR 64563
• Record Number: 2019-25401
• Section: Notices
• Court: Drug Enforcement Administration

Federal Register, Volume 84 Issue 226 (Friday, November 22, 2019)

[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
                [Notices]
                [Page 64563]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2019-25401]
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                DEPARTMENT OF JUSTICE
                Drug Enforcement Administration
                [Docket No. DEA-529]
                Bulk Manufacturer of Controlled Substances Application: Patheon
                API Manufacturing, Inc.
                ACTION: Notice of application.
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                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.
                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:
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                 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.
                 Dated: November 5, 2019.
                William T. McDermott,
                Assistant Administrator.
                [FR Doc. 2019-25401 Filed 11-21-19; 8:45 am]
                BILLING CODE 4410-09-P