N275075 N2 Ruling Active

The tariff classification of Valsartan/Sacubitril (CAS 936623-90-4) in bulk form, from Taiwan

Issued June 8, 2016 by U.S. Customs and Border Protection.

Tariff classification

HTS codes: 2933.99.5300

Headings: 2933

Product description

The information was sent to our laboratory for analysis and has been completed. Valsartan/Sacubitril is described as a crystal of two compounds with 1:1 ratio by molecule count. It is indicated for the treatment of heart conditions. In a report issued to us by the NY Laboratory, Valsartan/Sacubitril is a salt complex composed of sacubitril, valsartan, sodium cations, and water molecules in a ratio of 6:6:18:15 (asymmetric unit cell of the solid-state crystal).

CBP rationale

The applicable subheading for the Valsartan/Sacubitril in bulk form will be 2933.99.5300, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Aromatic or modified aromatic: Other: Drugs: Cardiovascular Drugs: Other.

Full text

N275075 June 8, 2016 CLA-2-29: OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 2933.99.5300 Ms. Amy Liang Pharmaports LLC 1 E. Uwchlan Avenue, Suite 116 Exton, PA 19341 RE: The tariff classification of Valsartan/Sacubitril (CAS 936623-90-4) in bulk form, from Taiwan Dear Ms. Liang: In your letter dated February 29, 2016, received in this office on April 12, 2016, you requested a tariff classification ruling. The information was sent to our laboratory for analysis and has been completed. Valsartan/Sacubitril is described as a crystal of two compounds with 1:1 ratio by molecule count. It is indicated for the treatment of heart conditions. In a report issued to us by the NY Laboratory, Valsartan/Sacubitril is a salt complex composed of sacubitril, valsartan, sodium cations, and water molecules in a ratio of 6:6:18:15 (asymmetric unit cell of the solid-state crystal). The applicable subheading for the Valsartan/Sacubitril in bulk form will be 2933.99.5300, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Aromatic or modified aromatic: Other: Drugs: Cardiovascular Drugs: Other.” The rate of duty will be 6.5 percent ad valorem. Currently, Valsartan/Sacubitril is not listed in the Pharmaceutical Appendix to the Tariff Schedule. 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 on World Wide Web 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 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, contact National Import Specialist Judy Lee at [email protected]. Sincerely, Deborah C. Marinucci Acting Director National Commodity Specialist Division

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