Search Results for keywords:"bulk manufacturer"

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Search Results: keywords:"bulk manufacturer"

  • Type:Notice
    Citation:90 FR 8153
    Reading Time:about a minute or two

    Noramco has submitted an application to the Drug Enforcement Administration (DEA) to become a registered bulk manufacturer of controlled substances. The company specifically plans to produce active pharmaceutical ingredients, including synthetic marihuana and tetrahydrocannabinols. Individuals or organizations can submit comments or objections to this application by March 25, 2025, through the Federal eRulemaking Portal. The announcement provides further details about the application and the procedures for submitting feedback.

    Simple Explanation

    Noramco wants permission from the US government to make certain special medicine ingredients, like fake marijuana, and people can tell the government if they think it's a good or bad idea until March 25, 2025.

  • Type:Notice
    Citation:90 FR 16556
    Reading Time:about a minute or two

    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.

    Simple Explanation

    The Research Triangle Institute wants to make special chemicals used for research, and the government (the DEA) is thinking about giving them permission. People can say what they think about it or ask for a meeting to talk about it before June 17, 2025.

  • Type:Notice
    Citation:86 FR 11329
    Reading Time:less than a minute

    Sigma Aldrich Research Biochemicals, Inc. has applied to the Drug Enforcement Administration (DEA) to become registered as a bulk manufacturer of controlled substances. The public is invited to submit comments or objections and request a hearing by April 26, 2021. The application was submitted on December 17, 2020, and aims to manufacture reference standards of certain controlled substances. Comments should be sent to the DEA at the address provided in the notice.

    Simple Explanation

    Sigma Aldrich Research Biochemicals wants permission to make certain types of special medicines and is asking for public feedback by April 26, 2021. They need to follow the rules to make sure the medicines are handled safely, and people can ask questions or share their thoughts with the DEA.

  • Type:Notice
    Citation:90 FR 13884
    Reading Time:about 2 minutes

    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.

    Simple Explanation

    The DEA is thinking about letting a company called Baxter Research Lab make a lot of a special plant called marihuana for scientific experiments, but only if they follow all the rules to keep it safe and not let it get into the wrong hands.

  • Type:Notice
    Citation:86 FR 3197
    Reading Time:less than a minute

    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.

    Simple Explanation

    Siemens Healthcare Diagnostics Inc. wants to make certain special medicines, and they have asked for permission from a group that checks if it's okay. People who have thoughts or worries about this can write to the group or ask to talk with them by March 15, 2021.

  • Type:Notice
    Citation:90 FR 9732
    Reading Time:about a minute or two

    Scottsdale Research Institute has applied to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of certain controlled substances. This registration will allow them to manufacture these substances for internal research and analytical development purposes only. Comments or objections regarding this application can be submitted electronically until April 21, 2025, via the Federal eRulemaking Portal. A hearing request can also be made by the same date.

    Simple Explanation

    Scottsdale Research Institute wants permission to make special medicines for research, and people can say what they think about it by April 21, 2025.

  • Type:Notice
    Citation:86 FR 9538
    Reading Time:about 2 minutes

    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.

    Simple Explanation

    The DEA is telling everyone that a company wants to grow marijuana for important science and medical studies, but before saying yes, they want to check very carefully that it's safe and legal.

  • Type:Notice
    Citation:90 FR 7172
    Reading Time:about a minute or two

    Groff Health, Inc. has applied to the Drug Enforcement Administration to become a bulk manufacturer of certain controlled substances. People can submit electronic comments or objections regarding this application by March 24, 2025. Comments must be submitted through the Federal eRulemaking Portal, and commenters will receive a tracking number to confirm successful submission. The company plans to produce these substances for internal use or sale but is not authorized for other activities related to these drug codes.

    Simple Explanation

    Groff Health, Inc. wants permission from the government to make certain special medicines, and people have until March 24, 2025, to say if they think it's a good or bad idea.

  • Type:Notice
    Citation:86 FR 2457
    Reading Time:less than a minute

    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.

    Simple Explanation

    Cedarburg Pharmaceuticals wants permission to make a chemical called THC in large amounts, and they asked a government group called the DEA to let them do this. People can tell the DEA what they think about this by March 15, 2021.

  • 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.