Search Results for keywords:"importer application"

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.

Fisher Clinical Services, Inc. has applied to the Drug Enforcement Administration (DEA) to register as an importer of certain controlled substances. The company intends to import these substances solely for clinical trials. Other types of uses or commercial sales are not allowed under this registration. Interested parties can submit comments or objections electronically by April 16, 2025, and can also request a hearing on the application by the same date.

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.

Vici Health Sciences, LLC has applied to become an importer of specific controlled substances to support their research and clinical trials. The Drug Enforcement Administration (DEA) is accepting public comments and objections to this application until February 27, 2025. Interested parties can submit their comments electronically through the Federal eRulemaking Portal. The DEA has specified that this permit will not authorize the import of finished medication forms for sale.

Pharmaron Manufacturing Services (US) LLC has applied to be registered as an importer of certain controlled substances. The Drug Enforcement Administration (DEA) announced this application and is inviting comments and requests for hearings from other registered bulk manufacturers and applicants until April 25, 2025. The company aims to use the imported substances for analytical purposes and production processes but is not authorized for commercial sale of finished dosage forms. The submission of comments should be done electronically through the Federal eRulemaking Portal.

Medi-Physics, Inc., which does business as GE Healthcare, has submitted an application to the Drug Enforcement Administration (DEA) to become an importer of specific controlled substances. The company intends to import small amounts of Ioflupane, which is an analogue of Cocaine, for research and development purposes, as the required form is unavailable in the U.S. Anyone wishing to comment or request a hearing on this application must do so by February 11, 2021. The DEA's approval will depend on compliance with specific regulatory standards.

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.

Siegfried USA, LLC, located in New Jersey, has submitted an application to become an importer of specific controlled substances, as noted by the Drug Enforcement Administration (DEA). The company plans to import these substances to create active pharmaceutical ingredients for its clients, specifically using Phenylacetone to produce Amphetamine. Comments or objections regarding this application are invited by March 18, 2021, and requests for a hearing can also be made by this date. Final permit approval will align with conditions outlined under the relevant U.S. Code and does not permit the commercial import of drug forms approved or non-approved by the Food and Drug Administration (FDA).

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.

Sigma Aldrich Co. LLC. has applied to the Drug Enforcement Administration (DEA) to become an importer of certain controlled substances, specifically for drug testing and analysis in research facilities. The application was submitted on January 15, 2021. Public comments or objections regarding this proposed registration are invited until March 18, 2021. The company plans to import synthetic Tetrahydrocannabinols; however, their registration does not authorize them to import finished drug products for commercial sale.