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Pharmaceutical Grade Lactose Monohydrate from Germany

Finely milled lactose monohydrate powder used as a filler and diluent in tablet manufacturing for pharmaceuticals. It falls under HTS 1702.19.00.00 as chemically pure lactose in solid form, distinct from food-grade or flavored variants. This classification applies to other lactose products beyond milk sugar or specific syrups.

Duty Rate — Germany → United States

10%

Rate breakdown

9903.05.3910%Except for products described in headings 9903.05.85–9903.05.92 and 9903.05.97, articles the product of a member state of the European Union, with an ad valorem (or ad valorem equivalent) rate of duty under column 1 less than 10 percent, as provided for in U.S. note 52 to this subchapter

Import Tips

• Verify purity certificates to confirm pharmaceutical grade and avoid reclassification under food headings

• Monitor Chapter 17 sugar quotas; lactose may count toward raw value limits if not exempted

• Include FDA compliance docs like Drug Master Files for pharma imports to prevent CBP holds