Search Results for keywords:"bulk manufacturer"

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.

The Drug Enforcement Administration (DEA) has announced that GGGYI LLC has applied to be registered as a bulk manufacturer of certain controlled substances, specifically marihuana, for research purposes. This application is part of DEA's program to oversee the cultivation and distribution of marihuana for scientific and medical research under strict regulations. Interested parties, such as existing manufacturers or applicants, can submit comments or objections regarding this application by April 26, 2021. The DEA will evaluate the application based on applicable laws and regulations to ensure proper safeguards against misuse are in place.

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.

Siemens Healthcare Diagnostics Inc. has submitted an application to the Drug Enforcement Administration to become a bulk manufacturer of certain controlled substances. The company intends to use these substances to produce products that are exempt from DEA regulations. Individuals or existing registered manufacturers can express their support or objections in writing by March 15, 2021, or request a hearing regarding this application by the same date.

The Drug Enforcement Administration (DEA) has announced that the Research Triangle Institute has applied to become a bulk manufacturer of certain controlled substances. The institute intends to produce these substances synthetically for research purposes and to provide analytical reference standards. Interested parties can submit electronic comments or objections regarding this registration by June 17, 2025, and can request a hearing by the same date. Comments are to be submitted through the Federal eRulemaking Portal at regulations.gov.

The Drug Enforcement Administration (DEA) announced that Mountain Trading LLC has applied to be registered as a bulk manufacturer of marihuana, a controlled substance listed under schedule I. The DEA will evaluate this application, along with others, based on the criteria set out in relevant laws and regulations. Current bulk manufacturers and other applicants can submit comments or objections to this application until April 19, 2021. If registered, the company will produce active pharmaceutical ingredients for research purposes only and must comply with established safeguards against drug diversion.

Patheon API Inc. has applied to the Drug Enforcement Administration to register as a bulk manufacturer of several controlled substances. The registration would allow the company to import these substances as reference standards for research and development in its API Manufacturing operations. Interested parties, including current registered bulk manufacturers, can submit comments or objections electronically by April 21, 2025, and may also request a hearing on the application by the same date. Comments submitted will be tracked, and successful submissions will receive a Comment Tracking Number.

Sigma Aldrich Research Biochemicals Inc. has applied to the Drug Enforcement Administration to become a registered bulk manufacturer of certain controlled substances. The company intends to produce these substances for use as reference standards only, and no other uses are approved under this registration. The public can submit comments or objections electronically regarding this application until May 12, 2025, through the Federal eRulemaking Portal. Additionally, requests for a hearing on the application must also be made by this date.

The Drug Enforcement Administration (DEA) has announced that the University of Kentucky Cannabis Center has applied to become a registered bulk manufacturer of controlled substances, specifically marihuana. This application, filed on July 1, 2024, aims to allow the center to produce bulk active pharmaceutical ingredients for research purposes. Interested parties can comment on or object to this application until April 14, 2025, through the Federal eRulemaking Portal. DEA will review the application to ensure it complies with laws and regulations, focusing on preventing the potential diversion of the controlled substance.

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.