Search Results for citation:"90 FR 9733"

Patheon API Inc. has applied to the Drug Enforcement Administration to register as a bulk manufacturer of several controlled substances. The registration would allow the company to import these substances as reference standards for research and development in its API Manufacturing operations. Interested parties, including current registered bulk manufacturers, can submit comments or objections electronically by April 21, 2025, and may also request a hearing on the application by the same date. Comments submitted will be tracked, and successful submissions will receive a Comment Tracking Number.

Janssen Pharmaceuticals, Inc. has applied to the Drug Enforcement Administration to be registered as a bulk manufacturer of certain controlled substances. The DEA has issued a notice inviting public comments or objections to this application and requests for a hearing on the matter, which must be submitted by April 21, 2025. Comments can be made electronically through the Federal eRulemaking Portal. Janssen plans to manufacture these substances for use as intermediates in sales to customers, and no other activities are allowed under this registration.

Purisys, LLC has applied to become a registered bulk manufacturer of certain controlled substances, as announced by the Drug Enforcement Administration (DEA) under the Justice Department. The company intends to produce these substances for use as active pharmaceutical ingredients and analytical reference standards, and to support clinical trials. People or companies who are already registered bulk manufacturers or applicants of these substances may submit comments or request a hearing on the application by April 21, 2025. Comments must be submitted electronically via the Federal eRulemaking Portal.