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Sulfadiazine Sodium Bulk API from Japan

Sulfadiazine sodium is a water-soluble salt form of the sulfonamide antibiotic sulfadiazine, listed specifically under HTS 2935.90.4200. Used in toxoplasmosis treatment and burn wound prophylaxis, this bulk active pharmaceutical ingredient (API) qualifies as a Chapter 29 sulfonamide drug. The sodium salt classification follows Chapter Note 5(C)(1) placing it with the parent organic compound.

Duty Rate — Japan → United States

27.5%

Rate breakdown

9903.04.6215%Patented pharmaceutical articles that are the product of Japan, of a European Union member country, of South Korea, of Switzerland, or of Liechtenstein as provided for in subdivisions (c) and (f) of U.S. note 40 to this subchapter
9903.05.4912.5%Except for products described in headings 9903.05.85–9903.05.92, articles the product of Japan, with an ad valorem (or ad valorem equivalent) rate of duty under column 1 less than 12.5 percent, as provided for in U.S. note 52 to this subchapter

Import Tips

• Include FDA import permit and reference to approved ANDA/NDA for sulfadiazine products to clear customs efficiently

• Verify sodium content declaration as salts must be classified with parent acid per Chapter 29 note 5(C)(1)