Search Results for keywords:"bulk manufacturer"

The Drug Enforcement Administration (DEA) has announced that Royal Beverages, LLC has applied to become a registered bulk manufacturer of marijuana, which is a Schedule I controlled substance. This registration would allow Royal Beverages, LLC, located in Harrisburg, Pennsylvania, to produce bulk active pharmaceutical ingredients (APIs) for research purposes. Comments or objections about this application can be submitted electronically through the Federal eRulemaking Portal before May 27, 2025. The DEA will evaluate the application based on certain legal regulations to ensure it complies with all laws and safeguards against illegal distribution.

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.

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.

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.

S&B Pharma, Inc. has applied to the Drug Enforcement Administration to be registered as a bulk manufacturer of certain controlled substances. The company intends to produce these substances in large quantities for product development and commercial sales. Specifically, S&B Pharma plans to create synthetic versions of Marihuana and Tetrahydrocannabinols. The public and current registered manufacturers have until April 26, 2021, to submit comments or request a hearing on this application.

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.

The Drug Enforcement Administration (DEA) has announced that Siegfried USA, LLC, located in Pennsville, New Jersey, has applied to be registered as a bulk manufacturer of certain controlled substances. Interested parties, including registered manufacturers of these substances, can submit comments or objections electronically by March 24, 2025. They can also request a hearing on the application by the same date. This registration will allow Siegfried USA to produce these substances in bulk for sale.

The Drug Enforcement Administration (DEA) has received an application from Titan Health LLC to become registered to manufacture bulk quantities of marihuana for research purposes. This notice invites current registered bulk manufacturers and applicants to submit comments or objections by April 19, 2021. The DEA will review the application according to regulations to ensure compliance with legal requirements and prevent unlawful distribution. If approved, Titan Health LLC would be authorized to manufacture pharmaceuticals for research but not engage in other activities without additional approval.

Patheon API Manufacturing, Inc. has applied to the Drug Enforcement Administration (DEA) to become a registered bulk manufacturer of certain controlled substances. The company intends to produce these substances as Active Pharmaceutical Ingredients (APIs) for its customers, specifically focusing on synthetic tetrahydrocannabinols. The public, including existing manufacturers and applicants, may submit comments or request a hearing on this application by April 20, 2021.

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.