Search Results for keywords:"bulk manufacturer"

The Drug Enforcement Administration (DEA) has announced that Sterling Pharma USA LLC has submitted an application to become a bulk manufacturer of controlled substances. Specifically, they plan to produce Tetrahydrocannabinols from hemp extract. People who are currently registered as bulk manufacturers of these substances, or who are applying to be, have the opportunity to file comments or objections regarding this application by April 6, 2021. They can also request a hearing before the same 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.

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) 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.

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.

Patheon Pharmaceuticals Inc. has applied to the Drug Enforcement Administration to become a registered bulk manufacturer of certain controlled substances. The company plans to use these substances as Active Pharmaceutical Ingredients in FDA-approved medications. Anybody interested can submit comments or objections electronically by May 12, 2025, through the Federal eRulemaking Portal. Requests for a hearing regarding this application are also due by the same date.

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.

The Drug Enforcement Administration (DEA) is notifying the public of an application from JW Colorado, LLC, to be registered as a bulk manufacturer of marihuana, a controlled substance listed under schedule I. The DEA will evaluate the application along with others under regulations meant to ensure that the growth of marihuana is for legitimate scientific and medical research purposes. Written comments or objections to this proposed registration must be submitted by April 19, 2021, and the evaluation will ensure compliance with all relevant laws and safeguards against misuse.

The Drug Enforcement Administration (DEA) has announced that Ohana Bio Pharma, LLC has applied to be registered as a bulk manufacturer of controlled substances in schedule I, specifically for marihuana. This application is part of a program to grow marihuana for scientific and medical research. The DEA will evaluate the application according to its regulations to ensure legal compliance and prevent any misuse. Interested parties can submit their comments or objections by May 27, 2025, through the Federal eRulemaking Portal.

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.