Federal Register #DEA-1706

DEA Notice: Leading Pharma LLC Application to Import Diphenoxylate (Schedule II) for R&D

This notice concerns Leading Pharma LLC's application to the Drug Enforcement Administration (DEA) for registration as an importer of the controlled substance Diphenoxylate (Schedule II). - Government Buyer: - Drug Enforcement Administration (DEA), Department of Justice - OEM/Vendor: - Leading Pharma LLC - Product Requested: - Diphenoxylate (Drug Code 9170, Schedule II) - Purpose: Import as an active pharmaceutical ingredient for research and development - Intended use: Manufacturing a finished dosage product for FDA approval - No commercial sale or other activities authorized under this registration - Unique Requirements: - Importation is strictly for research and development, not for commercial sale - DEA is soliciting comments or objections from registered bulk manufacturers and applicants - Place of Performance/Delivery: - Leading Pharma LLC, 3 Oak Road, Fairfield, NJ - DEA Contracting Office, 8701 Morrissette Drive, Springfield, VA

Description

Leading Pharma LLC has applied to be registered as an importer of basic classes of controlled substances, specifically Diphenoxylate (Schedule II). The company plans to import this controlled substance as an active pharmaceutical ingredient for research and development toward manufacturing a finished dosage product for FDA approval. No other activities for this drug code are authorized under this registration. Interested parties may submit comments or request a hearing by May 21, 2026.

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