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Pharmaceutical Fumaric Acid (Dimethyl Fumarate Precursor) from Japan

Ultra-pure fumaric acid for synthesis of dimethyl fumarate (Skilarence® active ingredient for psoriasis). Meets HTS 2917.19.1700 as chemically defined acyclic polycarboxylic acid without Chapter 29 exclusions.

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

• File FDA Drug Establishment Registration for precursor chemicals

• Provide DMF reference or CEP for European-sourced material

• Limit impurities to ICH Q3A standards (<0.1% individual)