3002.13.00.10/Rituximab Monoclonal Antibody/Japan

Rituximab Monoclonal Antibody from Japan

Rituximab is a genetically engineered chimeric monoclonal antibody targeting CD20 on B-cells, used primarily for treating non-Hodgkin lymphoma and rheumatoid arthritis. It falls under HTS 3002.13.0010 as an unmixed immunological product consisting of monoclonal antibodies obtained via biotechnological processes, not put up in measured doses for retail sale. This classification applies to bulk pharmaceutical-grade preparations for further formulation.

Duty Rate — Japan → United States

15%

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

9903.05.860%Articles provided for in subdivision (b) of U.S. note 52 to this subchapter

9903.05.900%Articles of aluminum, of steel or of copper or derivative aluminum or steel articles; passenger vehicles (sedans, sport utility vehicles, crossover utility vehicles, minivans and cargo vans) and light trucks; parts of passenger vehicles (sedans, sport utility vehicles, crossover utility vehicles, minivans and cargo vans) and light trucks; medium- and heavy-duty vehicles; parts of medium- and heavy-duty vehicles; wood products; patented pharmaceutical articles; and semiconductor articles, as provided in subdivision (f) of U.S. note 52 to this subchapter

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Import Tips

• Verify FDA import alerts and biologics license applications; monoclonal antibodies require prior approval via IND or BLA

• Ensure cold chain documentation (2-8°C) and Certificate of Analysis confirming purity >95% and biotech origin

• Avoid misclassification as finished injectables; bulk form must not be in measured doses to qualify