Bulk Manufacturer of Controlled Substances Application: Noramco
Noramco 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 infor...
Noramco 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 March 25, 2025. Such persons may also file a written request for a hearing on the application on or before March 25, 2025.
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 October 8, 2024, Noramco, 500 Swedes Landing Road, Wilmington, Delaware 19801-4417, 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
Marihuana
7360
I
Tetrahydrocannabinols
7370
I
Dihydromorphine
9145
I
Hydromorphinol
9301
I
Amphetamine
1100
II
Lisdexamfetamine
1205
II
Methylphenidate
1724
II
Nabilone
7379
II
Codeine
9050
II
( printed page 8154)
Dihydrocodeine
9120
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
Opium, granulated
9640
II
Oxymorphone
9652
II
Noroxymorphone
9668
II
Tapentadol
9780
II
The company plans to bulk manufacture the listed controlled substances as an Active Pharmaceutical Ingredient for supply to its customers. In reference to drug codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration.
www.regulations.gov
21 CFR 1301.33(a)