Pharmaron Manufacturing Services (US) LLC Application for Bulk Manufacturer Registration of Controlled Substances
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
Pharmaron Manufacturing Services (US) LLC has submitted an application to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of one or more basic classes of controlled substances. This notice serves as a public announcement of the application, as required under federal regulations governing the manufacture of controlled substances in the United States. As a bulk manufacturer, Pharmaron would be authorized to produce controlled substances at scale for distribution to other registered entities such as pharmaceutical companies, research institutions, and distributors. The company, a subsidiary of the China-based Pharmaron Beijing Co., Ltd., operates contract development and manufacturing (CDMO) services in the U.S. market. The DEA publishes such notices to allow interested parties to submit comments or objections before granting registration. The specific controlled substance schedules and drug codes covered by this application are detailed in the supplementary information accompanying the Federal Register notice. Registration, if approved, would be subject to ongoing DEA compliance requirements including security, recordkeeping, and reporting obligations.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Pharmaron Manufacturing Services (US) LLC has applied for DEA registration as a bulk manufacturer of controlled substances
- Public comment period opened for interested parties to submit objections or comments on the application
- If approved, Pharmaron would gain authorization to manufacture controlled substances at commercial scale in the United States
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Obligations
What this law requires
Submit application to DEA for bulk manufacturer registration of controlled substances and obtain approval before manufacturing
Maintain security measures and protocols as required by DEA regulations for bulk manufacturing facilities
Maintain detailed records of controlled substance manufacturing activities as required by DEA regulations
Submit required reports to DEA regarding controlled substance manufacturing and distribution activities
Allow interested parties to submit comments or objections to the DEA regarding the bulk manufacturer registration application