87 FR 20 pg. 4941 - Bulk Manufacturer of Controlled Substances Application: Siegfried USA, LLC
Type: NOTICEVolume: 87Number: 20Page: 4941
Page: 4941Docket number: [Docket No. DEA-947]
FR document: [FR Doc. 2022-01816 Filed 1-28-22; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-947]
Bulk Manufacturer of Controlled Substances Application: Siegfried USA, LLC
AGENCY:
Drug Enforcement Administration, Justice.
ACTION:
Notice of application.
SUMMARY:
Siegfried USA, LLC. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
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 April 1, 2022 Such persons may also file a written request for a hearing on the application on or before April 1, 2022.
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 December 8, 2021, Siegfried USA, LLC., 33 Industrial Park Road, Pennsville, New Jersey 08070-3244, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
| Controlled substance | Drug code | Schedule |
|---|---|---|
| Gamma Hydroxybutyric Acid | 2010 | I |
| Dihydromorphine | 9145 | I |
| Hydromorphinol | 9301 | I |
| Amphetamine | 1100 | II |
| Lisdexamfetamine | 1205 | II |
| Methylphenidate | 1724 | II |
| Amobarbital | 2125 | II |
| Pentobarbital | 2270 | II |
| Secobarbital | 2315 | II |
| Phenylacetone | 8501 | II |
| Codeine | 9050 | II |
| Oxycodone | 9143 | II |
| Hydromorphone | 9150 | II |
| Hydrocodone | 9193 | II |
| Methadone | 9250 | II |
| Methadone intermediate | 9254 | II |
| Morphine | 9300 | II |
| Oripavine | 9330 | II |
| Thebaine | 9333 | II |
| Opium tincture | 9630 | II |
| Oxymorphone | 9652 | II |
| Tapentadol | 9780 | II |
The company plans to manufacture the above-listed controlled substance in bulk for development of a new active pharmaceutical ingredient (API) and validation for a Drug Master File submission to the Food and Drug Administration. No other activity for this drug code is authorized for this registration.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2022-01816 Filed 1-28-22; 8:45 am]
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