Search Results for keywords:"bulk manufacturer"

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Search Results: keywords:"bulk manufacturer"

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  • 2025-05054 — Bulk Manufacturer of Controlled Substances Application: Sterling Wisconsin, LLC
    Type:Notice
    Citation:90 FR 13782
    Reading Time:about a minute or two

    The Drug Enforcement Administration (DEA) has announced that Sterling Wisconsin, LLC applied to register as a bulk manufacturer of certain controlled substances, specifically synthetic versions of Marihuana Extract, Marihuana, and Tetrahydrocannabinols. Interested parties can submit comments or objections electronically or request a hearing until May 27, 2025. The application was filed on January 30, 2025, and comments should be submitted via the Federal eRulemaking Portal as instructed.

    Simple Explanation

    Imagine a company wants permission to make a special kind of medicine from plants that are usually watched over closely. The people who make the rules asked others to tell them what they think before saying yes or no.

  • 2021-03363 — Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.
    Type:Notice
    Citation:86 FR 10353
    Reading Time:about a minute or two

    Patheon API Manufacturing, Inc. has applied to the Drug Enforcement Administration (DEA) to become a registered bulk manufacturer of certain controlled substances. The company intends to produce these substances as Active Pharmaceutical Ingredients (APIs) for its customers, specifically focusing on synthetic tetrahydrocannabinols. The public, including existing manufacturers and applicants, may submit comments or request a hearing on this application by April 20, 2021.

    Simple Explanation

    Patheon API Manufacturing, Inc. wants permission to make certain special medicines called controlled substances, and people can say if they think this is okay by April 20, 2021.

  • 2025-01347 — Bulk Manufacturer of Controlled Substances Application: Invizyne Technologies, Inc.
    Type:Notice
    Citation:90 FR 7173
    Reading Time:about a minute or two

    Invizyne Technologies, Inc. has applied to the Drug Enforcement Administration (DEA) to become a registered bulk manufacturer of certain controlled substances, including synthetic Tetrahydrocannabinols. Stakeholders, such as current manufacturers and applicants, can submit comments or objections electronically through the Federal eRulemaking Portal by March 24, 2025, and may also request a hearing by the same date. The DEA has provided detailed instructions for submitting comments online and has assured that comments will receive a Comment Tracking Number upon successful submission.

    Simple Explanation

    Invizyne Technologies, Inc. wants to make a special kind of medicine and they're asking permission from a big government team called the DEA. People who have something to say about this can write in their thoughts or ask for a meeting before March 24, 2025.

  • 2025-04284 — Bulk Manufacturer of Controlled Substances Application: Sterling Pharma USA LLC
    Type:Notice
    Citation:90 FR 12367
    Reading Time:about a minute or two

    Sterling Pharma USA LLC has applied to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of controlled substances. This application, filed on February 11, 2025, aims to support the company's internal research and provide substances for pre-clinical trial studies. The public can comment or object to this registration until May 16, 2025, through the Federal eRulemaking Portal.

    Simple Explanation

    Sterling Pharma USA wants permission to make special medicines and asked the DEA to approve this. People can tell the DEA what they think about this until May 16, 2025.

  • 2021-00647 — Bulk Manufacturer of Controlled Substances Application: IsoSciences, LLC
    Type:Notice
    Citation:86 FR 3197
    Reading Time:about a minute or two

    IsoSciences, LLC has applied to the Drug Enforcement Administration to become a bulk manufacturer of certain controlled substances. They plan to create synthetic versions of Marihuana and Tetrahydrocannabinols for use in analytical testing, and no other activities for these drugs are permitted with this registration. The public has until March 15, 2021, to submit written comments or objections, or to request a hearing regarding this application.

    Simple Explanation

    IsoSciences, LLC wants to make pretend versions of some special plants and substances to help scientists test them. People have until March 15, 2021, to say if they agree or disagree with this plan.

  • 2025-02593 — Bulk Manufacturer of Controlled Substances Application: Benuvia Operations, LLC
    Type:Notice
    Citation:90 FR 9553
    Reading Time:about a minute or two

    Benuvia Operations, LLC has applied to the Drug Enforcement Administration (DEA) to become a bulk manufacturer of certain controlled substances, which will be used for internal research and developing dosage formulations. The application was submitted on December 4, 2024. The DEA is inviting registered bulk manufacturers and applicants to submit comments or objections electronically by April 14, 2025. Comments should be submitted through the Federal eRulemaking Portal with instructions provided on the regulations.gov website.

    Simple Explanation

    Benuvia Operations, LLC wants permission to make certain special substances for research and medicine work, and people can tell the government what they think about this until April 14, 2025.

  • 2021-03836 — Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals
    Type:Notice
    Citation:86 FR 11557
    Reading Time:about a minute or two

    Chattem Chemicals has applied to the Drug Enforcement Administration (DEA) to become a registered bulk manufacturer of controlled substances. The application, filed on July 20, 2020, lists substances like Marihuana and Tetrahydrocannabinols, which the company plans to create synthetically for distribution and sale. Interested parties can submit comments or request a hearing on this application by April 26, 2021. Written comments should be sent to the DEA in Springfield, Virginia.

    Simple Explanation

    Chattem Chemicals wants to make a lot of certain special materials called "controlled substances," like fake versions of marihuana, in big amounts to sell. People can tell the people in charge what they think about this or ask to talk about it until April 26, 2021.

  • 2021-02970 — Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Mountain Trading LLC
    Type:Notice
    Citation:86 FR 9537
    Reading Time:about 2 minutes

    The Drug Enforcement Administration (DEA) announced that Mountain Trading LLC has applied to be registered as a bulk manufacturer of marihuana, a controlled substance listed under schedule I. The DEA will evaluate this application, along with others, based on the criteria set out in relevant laws and regulations. Current bulk manufacturers and other applicants can submit comments or objections to this application until April 19, 2021. If registered, the company will produce active pharmaceutical ingredients for research purposes only and must comply with established safeguards against drug diversion.

    Simple Explanation

    The DEA is letting everyone know that a company named Mountain Trading LLC has asked for permission to grow and make medicine from marihuana for research. They will check if it's safe and follows the rules, but haven't said exactly what all those rules are.

  • 2021-03837 — Bulk Manufacturer of Controlled Substances Application: S&B Pharma, Inc.
    Type:Notice
    Citation:86 FR 11558
    Reading Time:about a minute or two

    S&B Pharma, Inc. has applied to the Drug Enforcement Administration to be registered as a bulk manufacturer of certain controlled substances. The company intends to produce these substances in large quantities for product development and commercial sales. Specifically, S&B Pharma plans to create synthetic versions of Marihuana and Tetrahydrocannabinols. The public and current registered manufacturers have until April 26, 2021, to submit comments or request a hearing on this application.

    Simple Explanation

    S&B Pharma, Inc. wants permission from the government to make lots of special drugs called controlled substances, like fake versions of marijuana. People can tell the government what they think about this plan before April 26, 2021.

  • 2021-03754 — Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: GGGYI LLC
    Type:Notice
    Citation:86 FR 11328
    Reading Time:about 2 minutes

    The Drug Enforcement Administration (DEA) has announced that GGGYI LLC has applied to be registered as a bulk manufacturer of certain controlled substances, specifically marihuana, for research purposes. This application is part of DEA's program to oversee the cultivation and distribution of marihuana for scientific and medical research under strict regulations. Interested parties, such as existing manufacturers or applicants, can submit comments or objections regarding this application by April 26, 2021. The DEA will evaluate the application based on applicable laws and regulations to ensure proper safeguards against misuse are in place.

    Simple Explanation

    The DEA is looking at an application from a company called GGGYI LLC that wants to grow a big amount of marihuana for research to help doctors and scientists. People can say what they think about this idea until April 26, 2021, so the DEA can make sure it’s safe and done the right way.

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