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N269613 N2 Ruling Active

The tariff classification of Teduglutide (CAS 197922-42-2), Edoxaban (CAS 480449-70-5) and Valsartan (CAS 137862-53-4) in bulk form, from Taiwan

Issued November 12, 2015 by U.S. Customs and Border Protection.

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N2 N269613 (November 12, 2015)

Tariff classification

HTS codes: 2933.99.5300, 2934.99.3000, 2937.19.0000

Headings: 2937, 2934, 2933

Product description

The first product, Teduglutide, is a glucagon-like peptide-2 (GLP-2) analog. GLP2 is a naturally occurring hormone that regulates the growth, proliferation and maintenance of cells lining the gastrointestinal tract. Teduglutide is indicated for the treatment of short bowel syndrome (SBS). The second product, Edoxaban, is an anticoagulant that is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). The last product, Valsartan, is an angiotensin II receptor blocker that is indicated for treatment of hypertension and heart failure.

CBP rationale

The applicable subheading for Teduglutide in bulk form, will be 2937.19.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Hormones, prostaglandins, thromboxanes and leukotrienes, natural or reproduced by synthesis; derivatives and structural analogues thereof, including chain modified polypeptides, used primarily as hormones: Polypeptide hormones, protein hormones and glycoprotein hormones, their derivatives and structural analogues: Other. The applicable subheading for Edoxaban in bulk form, will be 2934.99.3000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Aromatic or modified aromatic: Other: Drugs. The applicable subheading for Valsartan 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

N269613 November 12, 2015 CLA-2-29:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 2937.19.0000; 2934.99.3000; 2933.99.5300 Ms. Amy Liang Pharmaports LLC 1 East Uwchlan Avenue, Suite 116 Exton, PA 19341 RE: The tariff classification of Teduglutide (CAS 197922-42-2), Edoxaban (CAS 480449-70-5) and Valsartan (CAS 137862-53-4) in bulk form, from Taiwan Dear Ms. Liang: In your letter dated October 8, 2015, you requested a tariff classification ruling. The first product, Teduglutide, is a glucagon-like peptide-2 (GLP-2) analog. GLP2 is a naturally occurring hormone that regulates the growth, proliferation and maintenance of cells lining the gastrointestinal tract. Teduglutide is indicated for the treatment of short bowel syndrome (SBS). The second product, Edoxaban, is an anticoagulant that is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). The last product, Valsartan, is an angiotensin II receptor blocker that is indicated for treatment of hypertension and heart failure. The applicable subheading for Teduglutide in bulk form, will be 2937.19.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Hormones, prostaglandins, thromboxanes and leukotrienes, natural or reproduced by synthesis; derivatives and structural analogues thereof, including chain modified polypeptides, used primarily as hormones: Polypeptide hormones, protein hormones and glycoprotein hormones, their derivatives and structural analogues: Other.” The rate of duty will be free. The applicable subheading for Edoxaban in bulk form, will be 2934.99.3000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Aromatic or modified aromatic: Other: Drugs.” Pursuant to General Note 13, HTSUS, the rate of duty will be free. The applicable subheading for Valsartan 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.” Pursuant to General Note 13, HTSUS, the rate of duty will be free. 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 http://www.usitc.gov/tata/hts/. 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, Gwenn Klein Kirschner Director National Commodity Specialist Division

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