Search Results for keywords:"21 U.S.C. 952(a)(2)"

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.

Curia New York, Inc. has applied to the Drug Enforcement Administration (DEA) to become an importer of controlled substances. The company intends to use these substances in bulk manufacturing to produce other controlled substances for their clients. Public feedback on the application can be submitted electronically until January 29, 2025. The application must align with DEA regulations and does not permit importing finished or unfinished drug products for commercial sale.

Catalent Pharma Solutions, LLC has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances. The company plans to import these substances in finished dosage forms for clinical trials, research, and analytical activities. Comments or objections regarding this application can be submitted electronically by March 28, 2025. Any hearing requests should be sent to the DEA at their Springfield, Virginia address.

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.

Myonex Inc has applied for registration as an importer of specific controlled substances, according to a notice from the Drug Enforcement Administration (DEA). The substances are intended for use in clinical trials, research, and analytical purposes, and not for commercial sale of finished dosage forms. Interested parties have until March 29, 2021, to submit written comments or objections, or to request a hearing regarding this application. Written submissions should be directed to the DEA at their office in Springfield, Virginia.

Globyz Pharma, LLC has applied to the Drug Enforcement Administration (DEA) for registration as an importer of controlled substances for analytical testing. The application does not authorize any other activities, such as importing FDA-approved finished dosage forms for sale. Interested parties, including registered manufacturers, can submit comments or objections, or request a hearing regarding this application by March 26, 2021. The DEA's decision will be based on alignment with legal requirements under 21 U.S.C. 952(a)(2).

Aveva Drug Delivery Systems, Inc. has applied to the Drug Enforcement Administration, a part of the Justice Department, to register as an importer of certain controlled substances. They intend to import these substances solely for analytical purposes and not for commercial sale. Interested parties can submit their comments or objections electronically, or request a hearing, by February 27, 2025. The registration is subject to specific regulations and permits as outlined in federal laws.

The Stepan Company has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances, as per the notice from the Justice Department's DEA. The application is to import these substances to manufacture other controlled substances, but not for commercial sale in finished form. Interested parties, such as current manufacturers or applicants, can comment or request a hearing about this application until April 9, 2025. Comments and hearing requests should be submitted through specified DEA addresses or electronically via the Federal eRulemaking Portal.

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.

Groff NA Hemplex, LLC has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of controlled substances, specifically for conducting clinical trial studies with Marihuana Extracts. The notice invites written comments or objections to the application by March 31, 2021, and allows requests for a hearing within the same deadline. The DEA has specified that this registration is only for scientific study and not for the commercial import of these substances.