GMP Manufactured Mycophenolate Mofetil from Japan
Mycophenolate mofetil produced under Good Manufacturing Practice (GMP) conditions for commercial generic drug production. Specific aromatic heterocyclic compound classified under HTS 2934.99.01.00 per Chapter 29 for bulk chemically defined organic pharmaceuticals. Full process validation and three-stage purification ensure regulatory compliance.
Duty Rate — Japan → United States
27.5%
Rate breakdown
9903.04.6215%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
• Submit executed batch records and GMP certificate from manufacturing site
• Elemental impurities testing per ICH Q3D required (Pd, Pt, Rh, Ru, Os, Ir <10ppm)
• Site inspected by FDA or EMA preferred for commercial scale imports