GMP Manufactured Mycophenolate Mofetil from Mexico
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 — Mexico → United States
10%
Rate breakdown
9903.05.5510%Section 301 (forced labor) — additional 10% ad valorem on products of Mexico
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