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3002.13.00.10/Denosumab Monoclonal Antibody/Japan

Denosumab Monoclonal Antibody from Japan

Denosumab (Prolia) fully human monoclonal antibody inhibiting RANKL for osteoporosis. Classifies unmixed under HTS 3002.13.0010 per chapter immunological definitions. Bulk for formulation.

Duty Rate — Japan → United States

0%

Rate breakdown

9903.05.860%Universal product exemption (U.S. note 52(b))
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Import Tips

• Include RANKL inhibition data

• FDA prior notice via PNSI system mandatory

• Document non-osteo appliance use