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Apresoline API (Hydralazine Hydrochloride) from Mexico

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 — Mexico → United States

110%

Rate breakdown

9903.04.60100%Except as provided in heading 9903.04.61, patented pharmaceutical articles as provided for in subdivisions (c) and (d) of U.S. note 40 to this subchapter
9903.05.5510%Except for products described in headings 9903.05.85–9903.05.92 and 9903.05.94, articles the product of Mexico, 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