Search Results for keywords:"DEA application"

Benuvia Operations, LLC has applied to the Drug Enforcement Administration (DEA) to become a bulk manufacturer of certain controlled substances, which will be used for internal research and developing dosage formulations. The application was submitted on December 4, 2024. The DEA is inviting registered bulk manufacturers and applicants to submit comments or objections electronically by April 14, 2025. Comments should be submitted through the Federal eRulemaking Portal with instructions provided on the regulations.gov website.

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.

The Drug Enforcement Administration (DEA) has announced that North Star Holdings California, LLC, has applied to become a registered bulk manufacturer of marihuana, a Schedule I controlled substance. This application is part of a DEA program that regulates the cultivation of marihuana for scientific and medical research purposes. The DEA will review this and similar applications to ensure compliance with relevant laws and regulations, ensuring that adequate measures are in place to prevent illegal distribution. Interested parties may submit comments or objections to the DEA regarding this application before April 19, 2021.

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.

Scottsdale Research Institute has applied to the Drug Enforcement Administration (DEA) to become a bulk manufacturer of certain controlled substances. This registration is intended to support the production of these substances for clinical trials and research purposes. The public can submit comments or objections electronically through the Federal eRulemaking Portal by April 21, 2025. The DEA requires comments to be submitted online and will provide a tracking number to confirm submission.

Irvine Labs Inc. has applied to the Drug Enforcement Administration (DEA) for registration as a bulk manufacturer of certain controlled substances. The application aims to facilitate research and development, as well as distribution to their research customers. The public can submit comments or objections about the application until February 28, 2025, via the Federal eRulemaking Portal. This notice was officially filed and noted by the DEA on December 27, 2024.