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9813.00.05/Pharmaceutical Stability Testing/Japan

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%Section 301 (forced labor) — Japan (col1 rate < 12.5 percent): MFN < 12.5% → total duty capped at 12.5%
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Import Tips

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