Apresoline API (Hydralazine Hydrochloride) from Germany
Bulk active pharmaceutical ingredient equivalent to Apresoline, consisting of pure hydralazine hydrochloride, a phthalazine-based vasodilator for hypertensive emergencies. HTS 2933.99.51.00 covers this specific listed cardiovascular drug as a separate chemically defined aromatic heterocyclic compound.
Duty Rate — Germany → United States
25%
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
9903.05.3910%Except for products described in headings 9903.05.85–9903.05.92 and 9903.05.97, articles the product of a member state of the European Union, with an ad valorem (or ad valorem equivalent) rate of duty under column 1 less than 10 percent, as provided for in U.S. note 52 to this subchapter
Import Tips
• Reference ANDA or DMF # on commercial invoice; generics without this face 3003/3004 scrutiny
• Test for hydrazine impurities (<1ppm) per ICH Q3D; elemental impurities cause holds
• Use NAFTA/USMCA certificate if from Canada/Mexico origin to claim preferential duty rates