Search Results for keywords:"DEA application"

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Search Results: keywords:"DEA application"

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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.

  • 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.

  • 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.

  • 2025-03636 — Importer of Controlled Substances Application: Aphena Pharma Solutions MD, LLC
    Type:Notice
    Citation:90 FR 11439
    Reading Time:about a minute or two

    Aphena Pharma Solutions MD, LLC has applied to the Drug Enforcement Administration (DEA) to be a registered importer of certain controlled substances. These substances will be used internally to manufacture an over-the-counter drug that is approved by the FDA. Interested parties, such as registered bulk manufacturers, can submit electronic comments or objections to this application by April 7, 2025. They can also request a hearing on the application within the same deadline.

    Simple Explanation

    A company named Aphena Pharma wants permission to bring in certain special ingredients that are used in making some medicines. People who think this is a good or bad idea can say so before the beginning of April 2025.

  • 2021-02980 — Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: North Star Holdings California, LLC
    Type:Notice
    Citation:86 FR 9536
    Reading Time:about 2 minutes

    The Drug Enforcement Administration (DEA) has announced that North Star Holdings California, LLC, has applied to become a registered bulk manufacturer of marihuana, a Schedule I controlled substance. This application is part of a DEA program that regulates the cultivation of marihuana for scientific and medical research purposes. The DEA will review this and similar applications to ensure compliance with relevant laws and regulations, ensuring that adequate measures are in place to prevent illegal distribution. Interested parties may submit comments or objections to the DEA regarding this application before April 19, 2021.

    Simple Explanation

    The DEA is thinking about letting a company, North Star Holdings California, grow a special type of plant called marihuana for scientists and doctors to study. People can tell the DEA what they think about this idea until April 19, 2021.

  • 2025-05060 — Importer of Controlled Substances Application: SpecGx LLC
    Type:Notice
    Citation:90 FR 13783
    Reading Time:about 2 minutes

    SpecGx LLC has applied to the Drug Enforcement Administration (DEA) to become an importer of certain controlled substances. The company intends to import specific drugs, including Tapentadol and Thebaine, for manufacturing purposes to create Active Pharmaceutical Ingredients. This notice allows registered manufacturers and other stakeholders to submit comments or request a hearing about this application by April 25, 2025. Approval for import will be strictly for manufacturing purposes and not for importing finished drug forms for sale.

    Simple Explanation

    SpecGx LLC wants permission from the government to bring in special ingredients from other countries to make medicine, but not to sell the medicine itself. People who make medicine or are interested can say what they think about this by a certain date.

  • 2025-01710 — Bulk Manufacturer of Controlled Substances Application: Noramco
    Type:Notice
    Citation:90 FR 8153
    Reading Time:about a minute or two

    Noramco has submitted an application to the Drug Enforcement Administration (DEA) to become a registered bulk manufacturer of controlled substances. The company specifically plans to produce active pharmaceutical ingredients, including synthetic marihuana and tetrahydrocannabinols. Individuals or organizations can submit comments or objections to this application by March 25, 2025, through the Federal eRulemaking Portal. The announcement provides further details about the application and the procedures for submitting feedback.

    Simple Explanation

    Noramco wants permission from the US government to make certain special medicine ingredients, like fake marijuana, and people can tell the government if they think it's a good or bad idea until March 25, 2025.

  • 2021-03760 — Bulk Manufacturer of Controlled Substances Application: Sigma Aldrich Research Biochemicals, Inc
    Type:Notice
    Citation:86 FR 11329
    Reading Time:less than a minute

    Sigma Aldrich Research Biochemicals, Inc. has applied to the Drug Enforcement Administration (DEA) to become registered as a bulk manufacturer of controlled substances. The public is invited to submit comments or objections and request a hearing by April 26, 2021. The application was submitted on December 17, 2020, and aims to manufacture reference standards of certain controlled substances. Comments should be sent to the DEA at the address provided in the notice.

    Simple Explanation

    Sigma Aldrich Research Biochemicals wants permission to make certain types of special medicines and is asking for public feedback by April 26, 2021. They need to follow the rules to make sure the medicines are handled safely, and people can ask questions or share their thoughts with the DEA.

  • 2021-00351 — Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals
    Type:Notice
    Citation:86 FR 2457
    Reading Time:less than a minute

    Cedarburg Pharmaceuticals has applied to the Drug Enforcement Administration (DEA) to become a registered bulk manufacturer of controlled substances. The company plans to produce synthetic Tetrahydrocannabinols (THC) as an active pharmaceutical ingredient for distribution. Interested parties, including current manufacturers or applicants, can submit comments or request a hearing regarding this application by March 15, 2021. The DEA is handling correspondence related to this application.

    Simple Explanation

    Cedarburg Pharmaceuticals wants permission to make a chemical called THC in large amounts, and they asked a government group called the DEA to let them do this. People can tell the DEA what they think about this by March 15, 2021.

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