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Pharmaceutical Calcium Gluconate for Injection API from Canada

Sterile bulk calcium gluconate API specifically for compounding 10% injection solutions to treat hypocalcemia. HTS 2918.16.5020 classification follows chapter note (C)(1) for organic salts used in pharma. High-purity with pyrogen-free certification.

Duty Rate — Canada → United States

110%

Rate breakdown

9903.04.6096.3%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
9903.05.2910%Except for products described in headings 9903.05.85–9903.05.93, articles the product of Canada, as provided for in U.S. note 52 to this subchapter

Import Tips

• Include DMF reference and Type II DMF letter for FDA; declare as API not finished drug

• Endotoxin testing (<0.5 EU/mg) required; provide LAL test certificates

• Particle size distribution report prevents classification disputes