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
15%
Rate breakdown
9903.04.6215%Pharmaceuticals: patented pharma from JP/EU/KR/CH/LI — 15% floor rate
9903.05.900%Articles already subject to Section 232 (steel/aluminum/copper + derivatives, autos + parts, wood, medium/heavy vehicles + parts, semiconductors, patented pharma) — U.S. note 52(f)
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