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Notice

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

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Start Preamble

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 substanceDrug codeSchedule
Thebaine9333II
Noroxymorphone9668II
Gamma Hydroxybutyric Acid2010I
Alpha-methyltryptamine7432I

The company plans to bulk manufacture the listed controlled substances as an Active Pharmaceutical Ingredient for supply to its customers.

Start Signature

Dated: November 5, 2019.

William T. McDermott,

Assistant Administrator.

End Signature End Supplemental Information

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

BILLING CODE 4410-09-P