Search Results for keywords:"Importer application"

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Search Results: keywords:"Importer application"

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  • 2025-02594 — Importer of Controlled Substances Application: Mylan Inc.
    Type:Notice
    Citation:90 FR 9556
    Reading Time:about a minute or two

    The Drug Enforcement Administration has announced that Mylan Inc. applied for registration to import certain controlled substances. These substances will be used as bulk active pharmaceutical ingredients for internal testing, as well as finished dosage forms for analytical testing and distribution for clinical trials in foreign markets. Comments or objections regarding this application can be submitted up to March 17, 2025, and requests for a hearing must follow specific submission guidelines. The approval of these permits will only occur if the activities align with the legal requirements under U.S. law.

    Simple Explanation

    Mylan Inc. wants to bring some special medicines from other countries to test and study them, but they need permission from the government to do so. People can say what they think about this until March 17, 2025, but the steps to say your opinion are not very clear.

  • 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.