Search Results for keywords:"importer registration"

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.

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.

Restek Corporation has applied to the Drug Enforcement Administration (DEA) to become a registered importer of certain controlled substances. These substances will be imported for use in manufacturing certified reference materials. The public can submit comments or objections to this application by April 28, 2025, through the Federal eRulemaking Portal. Approval will be granted only if the importation activities comply with legal requirements, with no permission for importing finished drug products for commercial sale.

The Indigenous Peyote Conservation Initiative has applied to the Drug Enforcement Administration (DEA) to become registered as an importer of certain controlled substances, specifically Peyote plants. They aim to use the imported Peyote for research, analysis, and conservation efforts related to South Texas Cacti. Public comments or objections to this application can be submitted until March 1, 2021, and requests for a hearing must also be made by then. The DEA will grant the registration only if the applicant's activities comply with authorized guidelines, and it does not include commercial importation of finished drug forms.

Sharp Clinical Services, LLC has submitted an application to register as an importer of certain controlled substances. The purpose of this registration is to import these substances for distribution and clinical trials, but not for commercial sales of finished products. The public can submit comments or objections electronically until March 28, 2025, and requests for a hearing on the application must be sent to the Drug Enforcement Administration by the same date.

Siegfried USA, LLC has submitted an application to the Drug Enforcement Administration (DEA) seeking approval to become an importer of certain controlled substances. The application is intended to allow the company to import these substances for the purpose of manufacturing bulk Active Pharmaceutical Ingredients for its customers. Interested parties, such as registered bulk manufacturers of these controlled substances, are invited to submit comments or objections to this application by January 29, 2025. Comments should be submitted electronically via the Federal eRulemaking Portal, and requests for a hearing can be sent to the DEA at the addresses provided in the document.

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.

Indivior Inc. has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances. They intend to import these substances in limited quantities for use in research, clinical trials, and for developing the manufacturing process of dosage forms. Comments or objections regarding this application can be submitted electronically by April 7, 2025, and requests for a hearing can also be made by that date. The DEA requires that comments be submitted through their online portal.