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Pentoxifylline API from Japan

Pentoxifylline is a xanthine derivative used as active pharmaceutical ingredient for circulation disorders, with methylxanthine core fitting 2933 nitrogen heterocycles. U.S. note 3 designated product. Bulk API form excludes finished drugs.

Duty Rate — Japan → United States

21%

Rate breakdown

9903.04.628.5%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 DMF reference number and FDA drug master file status

Include polymorph characterization to prevent patent disputes

Comply with cGMP requirements for API importation documentation