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
12.5%
Rate breakdown
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
• Maintain cold chain documentation; include batch records and test protocols; coordinate with FDA IND amendments