Kinetochem LLC Applies to Make Controlled Substances in Bulk
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On December 3, 2025, the Drug Enforcement Administration (DEA) announced that Kinetochem LLC has applied to be registered as a bulk manufacturer for several controlled substances. The notice was published in the Federal Register, Volume 90, Number 230.
Kinetochem LLC is located at 96 Market Street, Suite 102, Georgetown, Texas, 78626-3618. The company applied on October 15, 2025.
The application is for these controlled substances:
- Marihuana (drug code 7360, Schedule I)
- Tetrahydrocannabinols (drug code 7370, Schedule I)
- Psilocybin (drug code 7437, Schedule I)
- Psilocyn (drug code 7438, Schedule I)
Kinetochem LLC plans to make these controlled substances in bulk. They will make them as Active Pharmaceutical Ingredients (APIs) for use by customers. The substances will also be used for research and clinical trials.
For marihuana and tetrahydrocannabinols, the company will manufacture only synthetic versions. No other activities are allowed for these drug codes with this registration.
Anyone who is a registered bulk manufacturer of the affected substances, or is applying to be one, can submit comments or objections to the DEA by February 2, 2026. They can also ask for a hearing by that date.
Comments can be submitted electronically at https://www.regulations.gov. After submitting, the commenter will receive a Comment Tracking Number. Comments will not appear on the website right away.
This information was provided by Thomas Prevoznik, the Deputy Assistant Administrator of the DEA.
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