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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

137.5%

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
9903.05.3112.5%Except for products described in headings 9903.05.85–9903.05.92, articles the product of China, as provided for in U.S. note 52 to this subchapter
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)

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