Prednisolone Acetate Micronized from Japan
Micronized Prednisolone Acetate powder, the acetate ester derivative of prednisolone used primarily for injectable and ophthalmic suspensions due to its glucocorticoid hormone activity. Falls under HTS 2937.21.00.40 as a structural analogue of prednisolone (dehydrohydrocortisone) specifically named in the heading. The ester modification maintains its primary hormonal classification per Chapter 29 ester rules.
Duty Rate — Japan → United States
15%
Rate breakdown
9903.04.6215%Pharmaceuticals: patented pharma from JP/EU/KR/CH/LI — 15% floor rate
9903.05.860%Universal product exemption (U.S. note 52(b))
9903.05.900%Articles already subject to Section 232 (steel/aluminum/copper + derivatives, autos + parts, wood, medium/heavy vehicles + parts, semiconductors, patented pharma) — U.S. note 52(f)
Import Tips
• Include particle size distribution certificate and ester content assay; cold chain validation recommended for injectables
• File FDA Drug Master File (DMF) reference and ensure GMP certification from manufacturing site
• Avoid anti-dusting agent additions that could trigger Chapter 29 note (g) reclassification