Search Results for keywords:"Tapentadol"

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Search Results: keywords:"Tapentadol"

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  • 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.

  • 2021-02979 — Importer of Controlled Substances Application: S and B Pharma, Inc.
    Type:Notice
    Citation:86 FR 9535
    Reading Time:about a minute or two

    S&B Pharma, Inc. has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances. The company intends to import intermediate forms of Tapentadol for manufacturing purposes and ANPP to produce other controlled substances, but they will not import finished products for commercial sale. Interested parties, such as registered manufacturers, can submit comments, objections, or request a hearing regarding this application by March 18, 2021.

    Simple Explanation

    S&B Pharma, Inc. wants permission to bring in special ingredients that can be used to make certain medicines, but they don't want to sell final medicine products. People who are interested can tell the boss what they think by talking or asking questions before March 18, 2021.

  • 2025-03062 — Importer of Controlled Substances Application: S&B Pharma LLC DBA Norac Pharma
    Type:Notice
    Citation:90 FR 10732
    Reading Time:about a minute or two

    S&B Pharma LLC DBA Norac Pharma has submitted an application to the Drug Enforcement Administration (DEA) to register as an importer of certain controlled substances. The company intends to import intermediate forms of Tapentadol for further manufacturing and ANPP for producing other controlled substances. Public comments or objections to this application can be submitted electronically by March 28, 2025. The DEA will only approve import permits if the company's activities comply with specific federal regulations.

    Simple Explanation

    S&B Pharma wants permission from a special U.S. agency to bring in certain powerful medicine ingredients from other countries to make new medicines. People can tell the agency if they think this is okay or not until almost the end of March 2025.