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Importer of Controlled Substances Application: Leading Pharma LLC

The DEA published notice that Leading Pharma LLC, 3 Oak Road, Fairfield, New Jersey 07004, applied on March 25, 2026 to be registered as an importer of Diphenoxylate (drug code 9170, Schedule II controlled substance). The company plans to import the listed controlled substance as an active pharmaceutical ingredient for research and development toward manufacturing a finished dosage product for Food and Drug Administration approval. Public comments on the application and requests for a hearing must be submitted on or before May 21, 2026.

Leading Pharma LLC Controlled Substances Importer Application Notice

The DEA published notice that Leading Pharma LLC, located in Fairfield, New Jersey, applied on March 25, 2026 to be registered as an importer of Diphenoxylate (Drug Code 9170, Schedule II). The company plans to import the controlled substance as an active pharmaceutical ingredient for research and development toward manufacturing a finished dosage product for FDA approval. Registered bulk manufacturers and applicants may submit comments or objections on or before May 21, 2026.