Ketoconazole USP from Japan

Ketoconazole, a synthetic imidazole antifungal drug classified under HTS 2933.29.4500, contains an unfused imidazole ring critical to its mechanism. Used systemically for serious fungal infections and topically for dandruff/seborrheic dermatitis.

Duty Rate — Japan → United States

12.5%

Rate breakdown

9903.05.4912.5%Section 301 (forced labor) — Japan (col1 rate < 12.5 percent): MFN < 12.5% → total duty capped at 12.5%

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Import Tips

• Include hepatotoxicity risk assessment data; FDA heightened scrutiny post-market withdrawals

• Particle size distribution critical for bioavailability; provide laser diffraction analysis

• Genotoxic impurity limits (<1.5 ppm hydrazine) strictly enforced at entry