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

Department of Justice Drug Enforcement Administration [Docket No. DEA-636] ACTION: Notice of application. DATES: Registered bulk manufacturers of the affected basic class(es), a...

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Department of Justice

Drug Enforcement Administration

[Docket No. DEA-636]

ACTION:

Notice of application.

DATES:

Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before July 6, 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 February 21, 2020, Patheon A PI Manufacturing, Inc, 309 Delaware Street, Greenville, South Carolina 29605, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances:

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

The company plans to bulk manufacture the above-listed controlled substances as an Active Pharmaceutical Ingredient (API) for distribution to its customers. No other activities for these drug codes are authorized for this registration.

William T. McDermott,

Assistant Administrator.

[FR Doc. 2020-09556 Filed 5-4-20; 8:45 am]

BILLING CODE 4410-09-P

Legal Citation

Federal Register Citation

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85 FR 26715

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Suggested Web Citation

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“Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.,” thefederalregister.org (May 5, 2020), https://thefederalregister.org/documents/2020-09556/bulk-manufacturer-of-controlled-substances-application-patheon-api-manufacturing-inc.