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Clobazam API Micronized from Mexico

Micronized Active Pharmaceutical Ingredient (API) form of Clobazam for improved bioavailability in tablet formulations. As a pure chemically defined heterocyclic nitrogen compound (lactam), it qualifies under HTS 2933.72.00.00. Used exclusively as intermediate for epilepsy treatment medications.

Duty Rate — Mexico → United States

110%

Rate breakdown

9903.04.60100%Except as provided in heading 9903.04.61, patented pharmaceutical articles as provided for in subdivisions (c) and (d) of U.S. note 40 to this subchapter
9903.05.5510%Except for products described in headings 9903.05.85–9903.05.92 and 9903.05.94, articles the product of Mexico, as provided for in U.S. note 52 to this subchapter

Import Tips

• Include particle size distribution analysis in technical documentation to justify micronized form for manufacturing use

• Pre-register with FDA Drug Master File (DMF) system before import to streamline clearance for API shipments

• Avoid retail packaging; use industrial bulk drums to prevent misclassification as finished dosage form