Search Results for keywords:"Active Pharmaceutical Ingredients"

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.

Promega Corporation has applied to the Drug Enforcement Administration to register as a bulk manufacturer of certain controlled substances. This notice invites comments or objections to the proposed registration by May 27, 2025. Comments must be submitted electronically through the Federal eRulemaking Portal at regulations.gov. The substances will be manufactured as Active Pharmaceutical Ingredients for sale to customers, with no other uses authorized.

SpecGx LLC has applied to the Drug Enforcement Administration (DEA) to become an importer of certain controlled substances. The company intends to import specific drugs, including Tapentadol and Thebaine, for manufacturing purposes to create Active Pharmaceutical Ingredients. This notice allows registered manufacturers and other stakeholders to submit comments or request a hearing about this application by April 25, 2025. Approval for import will be strictly for manufacturing purposes and not for importing finished drug forms for sale.

Kinetochem LLC has filed an application to be registered as a bulk manufacturer of certain controlled substances. The company plans to manufacture these substances, including synthetic versions of Marihuana and Tetrahydrocannabinols, for use as Active Pharmaceutical Ingredients in research and clinical trials. The public or other manufacturers may submit comments or objections electronically by February 4, 2025, through the Federal eRulemaking Portal.

Royal Emerald Pharmaceuticals has applied to become a registered importer of certain controlled substances, specifically immature plants, which they intend to use for cultivating marijuana. The plants will be developed into botanical raw materials or Active Pharmaceutical Ingredients for approved medical, scientific, research, or industrial purposes. The application, submitted to the Drug Enforcement Administration (DEA), excludes importing FDA-approved or non-approved finished dosage forms intended for commercial sale. Comments or objections regarding this application can be submitted electronically until May 27, 2025.

SpecGx LLC has applied to the Drug Enforcement Administration (DEA) to become an importer of certain controlled substances. The company aims to import these substances for the purpose of manufacturing Active Pharmaceutical Ingredients, which will then be distributed to its customers. However, this registration does not automatically allow for permit applications to import these substances to be approved; approval will be granted only if the business activities comply with specific legal requirements. Public comments or requests for a hearing regarding this application are open until April 28, 2025, and can be submitted electronically through the Federal eRulemaking Portal.

SpecGx LLC is seeking to become a registered bulk manufacturer of certain controlled substances. The Drug Enforcement Administration (DEA) has announced the application and is allowing other existing bulk manufacturers and applicants to submit comments or objections electronically until June 24, 2025. Additionally, there is a provision for requesting a hearing on this application within the same timeframe. SpecGx plans to manufacture these substances mainly for use as Active Pharmaceutical Ingredients and Analytical Research Standards.

Siegfried USA, LLC has submitted an application to the Drug Enforcement Administration (DEA) seeking approval to become an importer of certain controlled substances. The application is intended to allow the company to import these substances for the purpose of manufacturing bulk Active Pharmaceutical Ingredients for its customers. Interested parties, such as registered bulk manufacturers of these controlled substances, are invited to submit comments or objections to this application by January 29, 2025. Comments should be submitted electronically via the Federal eRulemaking Portal, and requests for a hearing can be sent to the DEA at the addresses provided in the document.

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.