Search Results for keywords:"bulk manufacturer"

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.

Stepan Company has applied to the Drug Enforcement Administration (DEA) to become a bulk manufacturer of certain controlled substances. This request was made on January 31, 2025, and is currently open for public comment until June 17, 2025. Individuals who are already registered manufacturers of these substances or are applicants for such a registration can submit their comments or objections electronically through the Federal eRulemaking Portal. Interested parties may also request a hearing on this application before the deadline if desired.

The Drug Enforcement Administration (DEA) received an application from Baxter Research Lab to register as a bulk manufacturer of marihuana, a Schedule I controlled substance. This registration would allow Baxter to produce large quantities of active pharmaceutical ingredients (APIs) for research purposes. The DEA will review the application to ensure all legal and safety measures are in place to prevent misuse. Comments or objections regarding this application can be submitted electronically until May 27, 2025.

Pharmaron Manufacturing Services (US), LLC has applied to the Drug Enforcement Administration (DEA) to become a bulk manufacturer of certain controlled substances. This registration is intended to allow the company to produce materials for clinical trials. Interested parties can submit comments or request a hearing on the application by May 27, 2025, via the Federal eRulemaking Portal. The application was officially filed on February 11, 2025, and no other activities related to these substances are authorized beyond clinical trial production.

Maridose LLC has put in an application to register as a bulk manufacturer of certain controlled substances. This application is directed to the Drug Enforcement Administration (DEA) and aims to supply these substances to DEA-registered researchers for their approved studies. Interested parties, such as other registered manufacturers, have until April 14, 2025, to submit comments or objections electronically through the Federal eRulemaking Portal. They can also request a hearing on the application by this deadline.

IsoSciences, LLC has applied to the Drug Enforcement Administration to become a bulk manufacturer of certain controlled substances. They plan to create synthetic versions of Marihuana and Tetrahydrocannabinols for use in analytical testing, and no other activities for these drugs are permitted with this registration. The public has until March 15, 2021, to submit written comments or objections, or to request a hearing regarding this application.