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Sterile Mycophenolate Mofetil for Injection Formulation from Japan

Sterile-grade mycophenolate mofetil powder intended for IV injection formulation after further processing. Classified under HTS 2934.99.01.00 as bulk aromatic heterocyclic API despite sterile processing, per Chapter 29 notes excluding only finished medicaments. Meets parenteral quality standards with endotoxin limits <0.5 EU/mg.

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

• Provide bacterial endotoxin test results and sterility assurance documentation for parenteral use

• Nitrogen purged containers required to prevent oxidative degradation during ocean transit

• Particle size distribution data critical for injection formulation compatibility