Pharmaceutical Calcium Gluconate for Injection API from China

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 — China → United States

28.7%

Rate breakdown

9903.88.0325%Except as provided in headings 9903.88.13, 9903.88.18, 9903.88.33, 9903.88.34, 9903.88.35, 9903.88.36, 9903.88.37, 9903.88.38, 9903.88.40, 9903.88.41, 9903.88.43, 9903.88.45, 9903.88.46, 9903.88.48, 9903.88.56, 9903.88.64, 9903.88.66, 9903.88.67, 9903.88.68, or 9903.88.69, articles the product of China, as provided for in U.S. note 20(e) to this subchapter and as provided for in the subheadings enumerated in U.S. note 20(f)
9903.03.030%Articles the product of any country, as provided for in subdivision (aa)(ii) of U.S. note 2 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