Bulk Mycophenolate Mofetil API for Generic Production from Mexico

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 — Mexico → United States

0%

Rate breakdown

9903.03.030%Articles the product of any country, as provided for in subdivision (aa)(ii) of U.S. note 2 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