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
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 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