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HSChapter 30
U.S. imports of immunological products, unmixed, not put up in measured doses (HS 300213) totaled $19.1M in April 2026, traded with 23 countries.
Last updated: April 2026 dataMonoclonal antibodies and other unmixed immunological products not packaged for retail sale represent some of the highest-value pharmaceutical trade flows in the global biologics market, serving as bulk intermediates for finished biologic drug manufacturing. The US schedule provides a dedicated line for monoclonal antibodies (3002130010) alongside a broader immunological products line (3002130090), with a legacy undifferentiated line (3002130000) also present. Germany and Switzerland lead US imports under this heading, reflecting the concentration of major biopharmaceutical manufacturers and contract development organizations in those countries, with the United Kingdom and China also significant sources. Admissibility is complex; importers should consult a licensed customs broker and confirm FDA CBER or CDER authorization requirements applicable to the specific product.
AI-written summary of the official U.S. Census Bureau trade figures on this page — verify before relying on it.
These conditions define the boundary between bulk pharmaceutical intermediates (heading 300213) and finished or formulated biologics (heading 300215 or 300290). An immunological product that has been mixed with excipients, adjuvants, or other active substances, or that has been packaged in unit doses for retail or clinical use, would generally fall outside 300213 and require reclassification. Correct classification depends on the product's formulation state and packaging at the time of importation.
Bulk monoclonal antibodies imported as drug substances are subject to FDA oversight under either CDER (for therapeutic mAbs) or CBER (for certain diagnostic or blood-related mAbs), and the foreign manufacturing facility must hold an appropriate FDA establishment registration. Importers should also confirm whether the specific product requires an Investigational New Drug (IND) authorization or a Biologics License Application (BLA) before commercial importation is permissible.
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| Country | Imports | Exports | Balance |
|---|---|---|---|
| JAPAN | $13K | $12.9M | +$12.9M |
| IRELAND | -- | $11.7M | +$11.7M |
| GERMANY | $7.3M | $4.1M | -$3.2M |
| ITALY | $1.5M | $4.8M | +$3.3M |
| SWITZERLAND | $4.3M | $232K | -$4.1M |
Monthly import values over time
HS10 import codes under this HS6 parent. Source: U.S. Harmonized Tariff Schedule.
| Code | Description | Import Value | Effective Tariff % |
|---|---|---|---|
| 3002130010 | MONOCLONAL ANTIBODIES, UNMIXED, NOT RETAIL SALE | $11.5M | -- |
| 3002130090 | IMMUNOLOGICAL PRODUCTS, UNMIXED, NOT RETAIL SALE | $7.6M | -- |
MONOCLONAL ANTIBODIES, UNMIXED, NOT RETAIL SALE
IMMUNOLOGICAL PRODUCTS, UNMIXED, NOT RETAIL SALE
HS10 export codes under this HS6 parent. Source: U.S. Schedule B export classification.
| Code | Description | Export Value |
|---|---|---|
| 3002130000 | IMMUNOLOGICAL PRODUCTS,NOT MIXED NOT RETAIL SALE | $40.7M |
IMMUNOLOGICAL PRODUCTS,NOT MIXED NOT RETAIL SALE
609.1K kg
MEDICAMENTS NESOI, MEASURED DOSES, RETAIL PK NESOI
HS 300490
IMMUNOLOGICAL PRODUCTS, IN MEASURED DOESE/RTL SALE
HS 300215
VACCINES FOR HUMAN MEDICINE
HS 300241
HORMONES ETC. (NO ANTIBIOTICS CONTAINED) DOSAGE FM
HS 300439
ANTISERA AND OTHER BLOOD FRACTIONS
HS 300212
IMMUNOLOGICAL PRODUCTS, MIXED, NOT IN MSRED DOSES
HS 300214
| State | Imports | Exports | Balance |
|---|---|---|---|
| Massachusetts | $505K | $16.5M | +$16.0M |
| Rhode Island | -- | $11.4M | +$11.4M |
| Missouri | $1.5M | $4.9M | +$3.4M |
| Port | Imports | Exports | Balance |
|---|---|---|---|
| NEWARK, NJ | $4.6M | $13.1M | +$8.5M |
| JFK INTERNATIONAL AIRPORT, NY | $382K | $11.6M | +$11.2M |
| CHICAGO, IL | $5.3M | $5.6M | +$266K |