Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City
| Published date | 17 June 2020 |
| Citation | 85 FR 36617 |
| Record Number | 2020-13009 |
| Section | Notices |
| Court | Drug Enforcement Administration |
Federal Register, Volume 85 Issue 117 (Wednesday, June 17, 2020)
[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Page 36617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13009]
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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.
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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:
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Drug
Controlled substance code Schedule
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Gamma Hydroxybutyric Acid............... 2010 I
Amphetamine............................. 1100 II
Lisdexamfetamine........................ 1205 II
Methylphenidate......................... 1724 II
ANPP (4-Anilino-N-phenethyl-4- 8333 II
piperidine).
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
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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]
BILLING CODE 4410-09-P
