Pharmaceutical Calcium Gluconate for Injection API from Japan
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 — Japan → United States
23.8%
Rate breakdown
9903.04.6211.3%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
9903.05.4912.5%Except for products described in headings 9903.05.85–9903.05.92, articles the product of Japan, with an ad valorem (or ad valorem equivalent) rate of duty under column 1 less than 12.5 percent, 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