Pharmaceutical Stability Testing from Japan
Clinical trial drug batches exported for ICH stability chamber testing at accelerated conditions. Qualifies under 9813.00.05 for pharmaceutical validation processing before US FDA submission. Provides essential stability data for NDA filing.
Duty Rate — Japan → United States
10%
Rate breakdown
9903.03.0110%Except for products described in headings 9903.03.02–9903.03.11, articles the product of any country, as provided for in subdivision (aa) of U.S. note 2 to this subchapter
Import Tips
• Maintain cold chain documentation; include batch records and test protocols; coordinate with FDA IND amendments