Bulk Mycophenolate Mofetil API for Generic Production from Japan
Large-quantity bulk API mycophenolate mofetil specifically manufactured for generic pharmaceutical production of transplant rejection medications. Falls under HTS 2934.99.01.00 as the named aromatic heterocyclic compound per Chapter 29 legal notes. Chemically defined with specific morpholinoethyl ester structure distinguishing from other mycophenolic derivatives.
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 Type II Drug Master File to FDA covering manufacturing process, controls, and facilities
• Provide 3-party laboratory testing confirming absence of genotoxic impurities per ICH M7 guidelines
• Use ISBT 128 labeling for pharmaceutical containers to facilitate tracking through supply chain