Can I import APIs duty-free?

Many APIs qualify for duty-free entry under HTS General Note 13 (Pharmaceutical Appendix) if the compound is listed by its INN name. Camtom automatically checks eligibility against the current appendix list.

How are combination drugs classified?

Combination drugs classify under the subheading for their primary active ingredient or therapeutic use, per GRI 3(b). Camtom analyzes the formulation and applies the correct heading with supporting documentation.

What is the duty on finished tablets from India?

Finished pharmaceutical preparations under 3004 generally face 0% to 6.5% MFN duty. If India has GSP eligibility for the specific HTS code (note: GSP has been expired since 2020), the rate may differ. Camtom calculates the exact rate.

Does Camtom handle FDA-regulated classification?

Camtom focuses on HTS tariff classification, not FDA regulatory classification. However, the FDA product code often informs the correct HTS subheading, and Camtom uses this cross-reference where applicable.

Are biologics classified differently from small-molecule drugs?

Yes. Biologics like monoclonal antibodies and vaccines typically classify under 3002 (blood fractions, sera, vaccines) rather than 3003/3004. Camtom identifies biologic products and applies the correct subheading.

Can I import APIs duty-free?

Many APIs qualify for duty-free entry under HTS General Note 13 (Pharmaceutical Appendix) if the compound is listed by its INN name. Camtom automatically checks eligibility against the current appendix list.

How are combination drugs classified?

Combination drugs classify under the subheading for their primary active ingredient or therapeutic use, per GRI 3(b). Camtom analyzes the formulation and applies the correct heading with supporting documentation.

What is the duty on finished tablets from India?

Finished pharmaceutical preparations under 3004 generally face 0% to 6.5% MFN duty. If India has GSP eligibility for the specific HTS code (note: GSP has been expired since 2020), the rate may differ. Camtom calculates the exact rate.

Does Camtom handle FDA-regulated classification?

Camtom focuses on HTS tariff classification, not FDA regulatory classification. However, the FDA product code often informs the correct HTS subheading, and Camtom uses this cross-reference where applicable.

Are biologics classified differently from small-molecule drugs?

Yes. Biologics like monoclonal antibodies and vaccines typically classify under 3002 (blood fractions, sera, vaccines) rather than 3003/3004. Camtom identifies biologic products and applies the correct subheading.

HTS Classification by industry

HTS Classification for Pharmaceuticals

Pharmaceutical imports involve active pharmaceutical ingredients (APIs), finished dosage forms, biologics, and medical devices — each with distinct classification rules under Chapters 29, 30, and 90. The difference between a bulk chemical and a pharmaceutical preparation can mean 0% versus 6.5% duty. Camtom navigates INN names, dosage forms, and FDA regulatory classifications to find the optimal HTS code.

Classification challenges in your industry

Distinguishing between bulk APIs (Ch. 29) and dosage-form preparations (Ch. 30) when the product is partially formulated

Classifying combination drugs that contain multiple active ingredients under the correct subheading

Navigating the pharmaceutical appendix (HTS General Note 13) for duty-free eligibility on INN-listed compounds

Determining whether diagnostic kits classify as reagents (3822) or instruments (9027)

Handling biologics and biosimilars that do not fit neatly into traditional chemical classification categories

Common classification mistakes

Classifying a finished tablet under Chapter 29 (organic chemicals) instead of 3004 (medicaments in measured doses)

Missing duty-free treatment for INN-listed APIs that qualify under the pharmaceutical appendix

Classifying veterinary pharmaceuticals under human pharma subheadings — Chapter 30 separates these

Treating a medical device accessory as a pharma product when it should go under Chapter 90

Failing to declare the dosage form (capsule, injectable, topical) which drives the 6-digit classification

Key HTS chapters

Chapter 30 — Pharmaceutical products

Chapter 29 — Organic chemicals

Chapter 28 — Inorganic chemicals

Chapter 38 — Chemical products n.e.s.

Chapter 90 — Optical/medical instruments

Chapter 39 — Plastics (packaging, devices)

Duty rate range

Many APIs enter duty-free under the Pharmaceutical Appendix (General Note 13). Finished dosage forms under 3004 face 0% to 6.5% depending on formulation. Medical devices under Chapter 90 range from 0% to 2.5%.

Rules of origin

Under USMCA, pharmaceutical products qualify for preferential treatment when they undergo a tariff shift from Chapter 29 (API) to Chapter 30 (finished drug) within a USMCA country. Biologics produced in USMCA countries generally qualify. Certificate of origin or importer certification is required.

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