Search Results for keywords:"importer application"

Myonex LLC has submitted an application to the Drug Enforcement Administration (DEA) to become a registered importer of certain controlled substances. The company plans to import these substances in dosage forms specifically for use in clinical trials, research, and analytical work, but not for commercial sales. Interested parties, including manufacturers or other applicants, are invited to submit comments or objections to this application by May 19, 2025, and they also have the option to request a hearing. No commercial activities involving the finished dosage forms are allowed under this registration.

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).

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.

Fisher Clinical Services, Inc. has applied to the Drug Enforcement Administration to be registered as an importer of certain controlled substances. The purpose of this registration is solely for use in clinical trials, and not for the commercial sale of the substances. The public can submit comments or request a hearing about this application until April 14, 2025. Comments must be submitted electronically, and hearings can be requested in writing, with specific addresses provided for these submissions.

Groff NA Hemplex LLC has applied to the Drug Enforcement Administration to become a registered importer of certain controlled substances. These substances will be imported in bulk to produce research-grade materials for clinical trial studies, specifically involving Marihuana Extract compounds. The application process allows for public comments or objections and requests for a hearing until January 13, 2025. The comments should be submitted electronically through the Federal eRulemaking Portal, while hearing requests must be directed to the DEA's office in Springfield, Virginia.

Leading Pharma LLC has applied to register as an importer of controlled substances. This application is for research and development purposes, aiming toward creating a new pharmaceutical product that is pending approval by the Food and Drug Administration (FDA). Interested parties can submit comments or request a hearing regarding this application, with a deadline of January 17, 2025. The Drug Enforcement Administration (DEA) will approve the application only if it meets specific legal criteria.

VHG Labs, operating as LGC Standards, has submitted an application to the Drug Enforcement Administration (DEA) to become an importer of specific controlled substances, including synthetic cannabidiol and synthetic tetrahydrocannabinol. The company intends to supply these substances to research facilities for drug testing and analysis. Interested parties, such as existing manufacturers or applicants of these substances, can submit comments or request a hearing regarding this application before March 22, 2021. This notice does not permit the import of finished drugs for commercial sale.

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.

Janssen Pharmaceuticals Inc. has filed an application with the Drug Enforcement Administration (DEA) to become an importer of certain controlled substances for analytical purposes. Public comments or objections regarding this application are accepted until March 17, 2025. Hearings can also be requested by this date. Comments should be submitted via the Federal eRulemaking Portal, and requests for hearings must be sent to the DEA at specified addresses.

Medi-Physics Inc., doing business as GE Healthcare, has applied to register as an importer of certain controlled substances. They plan to use these substances for making a diagnostic product and reference standards but have not been authorized for other activities involving these substances. The public can submit comments or objections electronically by March 3, 2025, through the Federal eRulemaking Portal. Requests for a hearing on this application must also be submitted by the same date to the Drug Enforcement Administration.