Search Results for keywords:"active pharmaceutical ingredients"

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Search Results: keywords:"active pharmaceutical ingredients"

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  • 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.

  • 2025-02731 — Bulk Manufacturer of Controlled Substances Application: Purisys, LLC
    Type:Notice
    Citation:90 FR 9733
    Reading Time:about a minute or two

    Purisys, LLC has applied to become a registered bulk manufacturer of certain controlled substances, as announced by the Drug Enforcement Administration (DEA) under the Justice Department. The company intends to produce these substances for use as active pharmaceutical ingredients and analytical reference standards, and to support clinical trials. People or companies who are already registered bulk manufacturers or applicants of these substances may submit comments or request a hearing on the application by April 21, 2025. Comments must be submitted electronically via the Federal eRulemaking Portal.

    Simple Explanation

    Purisys, LLC wants to make certain special medicines, and this notice tells people how they can say if they think it's a good idea or not. They have until April 21, 2025, to share their thoughts.

  • 2021-02971 — Importer of Controlled Substances Application: Noramco Coventry, LLC
    Type:Notice
    Citation:86 FR 9536
    Reading Time:about a minute or two

    Noramco Coventry, LLC has applied to the Drug Enforcement Administration to become an importer of certain controlled substances like raw opium and poppy straw concentrate. These substances will be used to manufacture bulk active pharmaceutical ingredients (APIs) that the company distributes. They will also import other substances for comparison with their own products to ensure quality before exporting their APIs to foreign markets. Public comments or objections to this application, including requests for a hearing, can be submitted until March 18, 2021.

    Simple Explanation

    Noramco Coventry, LLC wants to get permission to bring certain special substances like parts of plants used to make medicine from other countries. They use these substances to make important medicine ingredients and check their quality before sending them to other countries. People can say what they think about this plan until March 18, 2021.