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Cross-Linked Potato Starch for Pharma from Japan

Cross-linked modified potato starch used as disintegrant in pharmaceutical tablets, not a finished medicament. Under HTS 3505.10.0045 as potato-derived modified starch, excluding chapter 30 products. Low reducing sugar confirms dextrin status.

Duty Rate — Japan → United States

12.5%

Rate breakdown

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

• FDA/USP compliance docs essential; affirm not 'prepared for therapeutic use' per chapter note

• Lab reports on cross-linking and potato source to prevent reclass to medicaments

• For pharma import, align with drug master files but classify as raw material