USMCA Compliance for Pharmaceutical Companies
Navigate USMCA compliance for pharmaceuticals and API ingredients. Understand origin rules, FDA requirements, and tariff implications for drug manufacturers.
65%
RVC Threshold
MEDIUM
Section 301 Exposure
Navigate USMCA compliance for pharmaceuticals and API ingredients. Understand origin rules, FDA requirements, and tariff implications for drug manufacturers.
Importers and exporters in the pharmaceuticals industry face unique compliance hurdles:
API sourcing often from China/India affects origin
FDA compliance is separate from tariff compliance
Chemical reaction rules interpretation
Long development cycles complicate planning
Track API and excipient origins for RVC calculation
Apply chemical reaction origin rules correctly
Generate certificates for pharmaceutical shipments
Plan supply chain for USMCA qualification
Unclear on API origin impact for finished drugs
Documented chemical reactions in US, achieved 72% RVC
Reduced duties on $8M annual exports to Canada
APIs from non-USMCA countries are non-originating for RVC calculation. However, chemical reactions performed in USMCA countries can confer origin regardless of where precursor chemicals originated.
FDA approval and USMCA qualification are completely separate requirements. A drug can be FDA-approved but not qualify for USMCA preferential treatment, or vice versa.
Pharmaceutical products typically require 65% Regional Value Content under USMCA. The high value of APIs can significantly impact this calculation.
Explore our in-depth guides to understand tariff rules affecting pharmaceuticals:
Learn how to calculate Regional Value Content and meet the 65% threshold for pharmaceuticals.
Understand Section 301 China tariffs and mitigation strategies for pharmaceuticals imports.
Step-by-step guide to generating USMCA Form D certificates for your pharmaceuticals products.
Master HS code classification for accurate tariff calculation and USMCA qualification.
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