Search Results for keywords:"bulk manufacturer"

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Search Results: keywords:"bulk manufacturer"

  • Type:Notice
    Citation:86 FR 11330
    Reading Time:about a minute or two

    Synthcon LLC has applied to be registered as a bulk manufacturer of controlled substances, according to a notice from the Drug Enforcement Administration under the Department of Justice. The company intends to produce these substances for use as reference materials, proficiency tests, and academic research. Interested parties, such as current bulk manufacturers and applicants, are invited to submit comments or objections to this application by April 26, 2021, and may also request a hearing by the same date. Written comments can be sent to the DEA at their address in Springfield, Virginia.

    Simple Explanation

    Synthcon LLC wants to make certain special substances for tests and research, but they need permission from the government first. People have until April 26, 2021, to say if they think it's a good or bad idea.

  • Type:Notice
    Citation:90 FR 12367
    Reading Time:about a minute or two

    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.

    Simple Explanation

    Sterling Pharma USA wants permission to make special medicines and asked the DEA to approve this. People can tell the DEA what they think about this until May 16, 2025.

  • Type:Notice
    Citation:90 FR 7173
    Reading Time:about a minute or two

    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.

    Simple Explanation

    Siegfried USA, a company in New Jersey, wants permission to make special medicine ingredients in large amounts, and people can tell the government what they think about this by March 24, 2025.

  • Type:Notice
    Citation:86 FR 9539
    Reading Time:about 2 minutes

    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.

    Simple Explanation

    The DEA is looking at an application from a company named Titan Health LLC that wants to make lots of a special plant called marihuana for researchers to study. This plan is just for scientists' work, and the DEA will carefully check things to ensure that Titan Health follows the rules.

  • Type:Notice
    Citation:90 FR 16554
    Reading Time:about a minute or two

    Patheon API Services Inc. has applied to the Drug Enforcement Administration (DEA) to become a registered bulk manufacturer of certain controlled substances. This registration is intended to support the clinical trials of their customers. Interested parties are invited to submit comments or objections electronically through the Federal eRulemaking Portal by June 17, 2025. They may also request a hearing on the application by the same date.

    Simple Explanation

    Patheon API Services Inc. wants to make some special medicines and needs permission from a government group called the DEA. People can say what they think about this or ask for a meeting about it before June 17, 2025.

  • Type:Notice
    Citation:86 FR 10353
    Reading Time:about a minute or two

    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.

    Simple Explanation

    Patheon API Manufacturing, Inc. wants permission to make certain special medicines called controlled substances, and people can say if they think this is okay by April 20, 2021.

  • Type:Notice
    Citation:90 FR 16555
    Reading Time:about a minute or two

    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.

    Simple Explanation

    Stepan Company wants permission to make certain special substances, and people can say if they think it's a good or bad idea until June 17, 2025, but we don't know which substances or how this decision might affect others.

  • Type:Notice
    Citation:86 FR 11328
    Reading Time:about 2 minutes

    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.

    Simple Explanation

    The DEA is looking at an application from a company called GGGYI LLC that wants to grow a big amount of marihuana for research to help doctors and scientists. People can say what they think about this idea until April 26, 2021, so the DEA can make sure it’s safe and done the right way.

  • Type:Notice
    Citation:90 FR 9553
    Reading Time:about a minute or two

    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.

    Simple Explanation

    Benuvia Operations, LLC wants permission to make certain special substances for research and medicine work, and people can tell the government what they think about this until April 14, 2025.

  • Type:Notice
    Citation:86 FR 11557
    Reading Time:about a minute or two

    Chattem Chemicals has applied to the Drug Enforcement Administration (DEA) to become a registered bulk manufacturer of controlled substances. The application, filed on July 20, 2020, lists substances like Marihuana and Tetrahydrocannabinols, which the company plans to create synthetically for distribution and sale. Interested parties can submit comments or request a hearing on this application by April 26, 2021. Written comments should be sent to the DEA in Springfield, Virginia.

    Simple Explanation

    Chattem Chemicals wants to make a lot of certain special materials called "controlled substances," like fake versions of marihuana, in big amounts to sell. People can tell the people in charge what they think about this or ask to talk about it until April 26, 2021.

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