Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City
Cambrex Charles City has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for furth...
Cambrex Charles City 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 submit electronic comments on or objections to the issuance of the proposed registration on or before October 26, 2026. Such persons may also file a written request for a hearing on the application on or before October 26, 2026.
ADDRESSES:
The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to
www.regulations.gov
and follow the online instructions at that site for submitting comments. Upon submission of your comment, you will receive a Comment Tracking Number. Please be aware that submitted comments are not instantaneously available for public view on
www.regulations.gov.
If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment.
SUPPLEMENTARY INFORMATION:
In accordance with 21 CFR 1301.33(a), this is notice that on June 22, 2026, 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 substance(s):
Controlled substance
Drug
code
Schedule
Gamma Hydroxybutyric Acid
2010
I
Tetrahydrocannabinols
7370
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
Methadone
9250
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 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. In reference to drug code 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture this drug as synthetic. No other activities for these drug codes are authorized for this registration.
www.regulations.gov
21 CFR 1301.33(a)