Search Results for keywords:"importer application"

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.

Microgenics Corporation, a part of Thermo Fisher Scientific, has applied to the Drug Enforcement Administration (DEA) to become a registered importer of certain controlled substances. These substances are intended for use in feasibility and cross-reactivity studies related to diagnostic products. Comments and objections regarding this application, as well as requests for a hearing, must be submitted to the DEA by March 31, 2021. The DEA will only approve the permit if the company’s activities align with specific legal requirements under U.S. law.

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.

Mylan Pharmaceuticals, Inc. has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of basic classes of controlled substances. Interested parties, such as registered bulk manufacturers, can submit electronic comments or objections about this application by March 20, 2025, or request a hearing. Comments should be submitted through the Federal eRulemaking Portal, and requests for a hearing should be sent to the DEA's specified addresses. Mylan Pharmaceuticals seeks authorization to import controlled substances in finished dosage form for commercial distribution, with certain restrictions aligning with legal requirements.

Catalent Greenville, Inc. has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances. The company plans to use these substances for developing bulk dosage formulations for research and clinical trials. People or organizations that have an interest in this matter can submit comments or request a hearing by March 3, 2025. Submissions can be made through the Federal eRulemaking Portal, and hearings request should be sent to the DEA at specified addresses.

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.

Mylan Pharmaceuticals Inc. has submitted an application to be recognized as an importer of controlled substances. The Drug Enforcement Administration (DEA), a part of the Justice Department, is providing notice of this application. Interested parties, such as other registered manufacturers or applicants, have the opportunity to submit written comments, objections, or requests for a hearing on this application by March 8, 2021. Comments and hearing requests should be sent to the DEA at their Springfield, Virginia address.

Patheon API Services, Inc. has applied to the Drug Enforcement Administration (DEA) to become an importer of certain controlled substances. They intend to use these substances as reference standards in research and development for API Manufacturing, and not for any commercial sales. People affected by this application can submit comments or request a hearing by April 28, 2025. All comments must be submitted electronically through the Federal eRulemaking Portal.

Scottsdale Research Institute has applied to the Drug Enforcement Administration to become an importer of basic classes of controlled substances for clinical research. Specifically, they plan to bring in synthetic cannabidiol for use by Schedule I researchers. People interested in this application can submit comments or request a hearing by May 19, 2025. The application does not include permission for importing substances for commercial sale.

S&B Pharma LLC, also known as Norac Pharma, has submitted an application to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances. The company plans to import these substances in bulk to manufacture other controlled drugs for its customers. The public can submit comments or request a hearing regarding this application until February 11, 2021. All submissions should be sent to the DEA offices in Springfield, Virginia.