Search Results for keywords:"SpecGx LLC"

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Search Results: keywords:"SpecGx LLC"

  • Type:Notice
    Citation:90 FR 13894
    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 aims to import these substances for the purpose of manufacturing Active Pharmaceutical Ingredients, which will then be distributed to its customers. However, this registration does not automatically allow for permit applications to import these substances to be approved; approval will be granted only if the business activities comply with specific legal requirements. Public comments or requests for a hearing regarding this application are open until April 28, 2025, and can be submitted electronically through the Federal eRulemaking Portal.

    Simple Explanation

    SpecGx LLC wants special permission to bring certain medicines from other countries to make ingredients for other medicines, but they need to follow strict rules, and people can say what they think about this until April 28, 2025.

  • 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.