Search Results for keywords:"DEA application"

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.

Organic Standards Solutions International, LLC has applied to the Drug Enforcement Administration (DEA) to register as an importer of certain controlled substances. The company aims to import substances like Marihuana Extract, Marihuana, and a synthetic version of Tetrahydrocannabinols to create analytical reference standards for customers. The public can comment or request a hearing on this application by January 6, 2025, through the Federal eRulemaking Portal. Permits will be approved only if the business activities align with legal requirements, and the company is not authorized to import FDA-approved or non-approved finished products for sale.

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.

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.

Sterling Pharma USA LLC has applied to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of controlled substances. This application, filed on February 11, 2025, aims to support the company's internal research and provide substances for pre-clinical trial studies. The public can comment or object to this registration until May 16, 2025, through the Federal eRulemaking Portal.

Invizyne Technologies, Inc. has applied to the Drug Enforcement Administration (DEA) to become a registered bulk manufacturer of certain controlled substances, including synthetic Tetrahydrocannabinols. Stakeholders, such as current manufacturers and applicants, can submit comments or objections electronically through the Federal eRulemaking Portal by March 24, 2025, and may also request a hearing by the same date. The DEA has provided detailed instructions for submitting comments online and has assured that comments will receive a Comment Tracking Number upon successful submission.

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.

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.

Sigma Aldrich Research Biochemicals, Inc. has applied to the Drug Enforcement Administration (DEA) to become registered as a bulk manufacturer of controlled substances. The public is invited to submit comments or objections and request a hearing by April 26, 2021. The application was submitted on December 17, 2020, and aims to manufacture reference standards of certain controlled substances. Comments should be sent to the DEA at the address provided in the notice.

Cedarburg Pharmaceuticals has applied to the Drug Enforcement Administration (DEA) to become a registered bulk manufacturer of controlled substances. The company plans to produce synthetic Tetrahydrocannabinols (THC) as an active pharmaceutical ingredient for distribution. Interested parties, including current manufacturers or applicants, can submit comments or request a hearing regarding this application by March 15, 2021. The DEA is handling correspondence related to this application.