N332208

N332208 May 10, 2023 CLA-2-29:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 2933.49.2600 Sheila Heerdt Ren Pharm International Ltd. 350 Jericho Turnpike, Suite 204 Jericho, NY 11753 RE: The tariff classification of Lenvatinib Mesylate (CAS No. 857890-39-2) in bulk powder form, from Italy Dear Ms. Heerdt: In your letter dated April 12, 2023, you requested a tariff classification ruling. Lenvatinib Mesylate, imported in bulk powder form, is a receptor tyrosine kinase (RTK) inhibitor. It is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine (RAI)-refractory differentiated thyroid cancer and renal cell carcinoma. The applicable subheading for the Lenvatinib Mesylate in bulk form will be 2933.49.2600, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing in the structure a quinoline or isoquinoline ring-system (whether or not hydrogenated), not further fused: Other: Other: Drugs: Other.” Pursuant to GN 13, HTSUS, the rate of duty will be free. Lenvatinib Mesylate is listed in Table 3 of the Pharmaceutical Appendix. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided at https://hts.usitc.gov/current This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact National Import Specialist Judy Lee at judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division