85 FR 117 pg. 36617 - Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City
Type: NOTICEVolume: 85Number: 117Page: 36617
Page: 36617Docket number: [Docket No. DEA-668]
FR document: [FR Doc. 2020-13009 Filed 6-16-20; 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-668]
Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City
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 August 17, 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 May 6, 2020, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616-3466, 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 |
| Amphetamine | 1100 | II |
| Lisdexamfetamine | 1205 | II |
| Methylphenidate | 1724 | II |
| ANPP (4-Anilino-N-phenethyl-4-piperidine) | 8333 | II |
| Phenylacetone | 8501 | II |
| Codeine | 9050 | II |
| Oxycodone | 9143 | II |
| Hydromorphone | 9150 | II |
| Hydrocodone | 9193 | II |
| Morphine | 9300 | II |
| Oripavine | 9330 | II |
| Thebaine | 9333 | II |
| Opium extracts | 9610 | II |
| Opium fluid extract | 9620 | II |
| Opium tincture | 9630 | II |
| Opium, powdered | 9639 | II |
| Oxymorphone | 9652 | II |
| Noroxymorphone | 9668 | II |
| Fentanyl | 9801 | II |
The company plans to manufacture the above-listed controlled substances in bulk for conversion to other controlled substances and sales to its customers for dosage form development, clinical trials and use in stability qualification studies. No other activities for these drug codes are authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-13009 Filed 6-16-20; 8:45 am]
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