Notices. Notice of application
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/register/2020/06/17/2020-13009A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4410-09-P 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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