Ketoconazole USP from China

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 — China → United States

28.7%

Rate breakdown

9903.88.0325%Except as provided in headings 9903.88.13, 9903.88.18, 9903.88.33, 9903.88.34, 9903.88.35, 9903.88.36, 9903.88.37, 9903.88.38, 9903.88.40, 9903.88.41, 9903.88.43, 9903.88.45, 9903.88.46, 9903.88.48, 9903.88.56, 9903.88.64, 9903.88.66, 9903.88.67, 9903.88.68, or 9903.88.69, articles the product of China, as provided for in U.S. note 20(e) to this subchapter and as provided for in the subheadings enumerated in U.S. note 20(f)
9903.03.030%Articles the product of any country, as provided for in subdivision (aa)(ii) of U.S. note 2 to this subchapter

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