2934.99.01.00/Mycophenolate Mofetil Hydrochloride/Germany

Mycophenolate Mofetil Hydrochloride from Germany

Mycophenolate mofetil hydrochloride is the hydrochloride salt form of mycophenolate mofetil, a semi-synthetic immunosuppressant derived from mycophenolic acid with a morpholinoethyl ester group. It falls under HTS 2934.99.01.00 as a specific aromatic heterocyclic compound used primarily to prevent organ transplant rejection by inhibiting lymphocyte proliferation. This chemically defined compound contains a fused heterocyclic ring system characteristic of Chapter 29 heading 2934.

Duty Rate — Germany → United States

25%

Rate breakdown

9903.04.6215%Patented pharmaceutical articles that are the product of Japan, of a European Union member country, of South Korea, of Switzerland, or of Liechtenstein as provided for in subdivisions (c) and (f) of U.S. note 40 to this subchapter

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

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Import Tips

• Obtain FDA approval and Drug Master File (DMF) documentation prior to importation as this is a bulk pharmaceutical chemical

• Ensure Certificate of Analysis (CoA) verifies purity >98% and confirms identity via HPLC matching reference standards

• Avoid misclassification as a finished dosage form; provide documentation proving it's bulk API not formulated tablets/capsules