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L86579 L8 Ruling Active

The tariff classification of MTP-PE,Na (CAS 838853-48-8); Ularitide Acetate; and PSN 357 AB from Switzerland.

Issued October 20, 2005 by U.S. Customs and Border Protection.

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L8 L86579 (October 20, 2005)

Tariff classification

HTS codes: 2924.19.1050, 2937.19.0000, 2933.39.6190

Headings: 2924, 2937, 2933

Product description

Ularitide Acetate is one of a number of peptide hormones known as atrial natriuretic peptide (ANF, ANP, ANH) hormones. It is believed to have a broad spectrum of synergistic effects, including vasodilation, diuresis, natriuresis, bronchodilation, renin, angiotensisn, and aldosterone antagonism. It is currently undergoing Phase II clinical tests for the relief of patients' symptoms in decompensated congestive heart failure by improving the hemodynamic state.

CBP rationale

The applicable subheading for Ularitide Acetate, imported in bulk form, will be 2937.19.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for "Polypeptide hormones, protein hormones and glycoprotein hormones, their derivatives and structural analogues: other”. The applicable subheading for MTP-PE,Na (Chemical Name – L-Alaninamide, H-(N-Acetylmuramoyl)-L-Alanyl-D-Alpha-Glutaminyl-N-[(7R)-4-Hydroxy-4-Oxido-10-Oxo-7-{(1-Oxohexadecyl)Oxy]-3,5,9-Trioxa-4-Phospha- pentacos-1-YL]-, Monosodium Salt, Hydrate) will be 2924.19.1050, Harmonized Tariff Schedule of the United States (HTS), which provides for acyclic amides (including acyclic carbamates) and their derivatives; salts thereof: other: amides… other. The applicable subheading for PSN 357 AB will be 2933.39.6190, Harmonized Tariff Schedule of the United States (HTS), which provides for heterocyclic compounds with nitrogen hetero-atom(s) only: compounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure: other.

Full text

NY L86579 October 20, 2005 CLA-2-29:RR:NC:2:239 L86579 CATEGORY: Classification TARIFF NO.: 2924.19.1050, 2937.19.0000, 2933.39.6190 Mr. Richard D’Innocenzo Genzyme Corporation One Kendall Square Cambridge, MA 02139 RE: The tariff classification of MTP-PE,Na (CAS 838853-48-8); Ularitide Acetate; and PSN 357 AB from Switzerland. In your letter dated July 25, 2005, you requested a tariff classification ruling for the above products which you have stated will be used in the formulation of active pharmaceutical ingredients. Ularitide Acetate is one of a number of peptide hormones known as atrial natriuretic peptide (ANF, ANP, ANH) hormones. It is believed to have a broad spectrum of synergistic effects, including vasodilation, diuresis, natriuresis, bronchodilation, renin, angiotensisn, and aldosterone antagonism. It is currently undergoing Phase II clinical tests for the relief of patients' symptoms in decompensated congestive heart failure by improving the hemodynamic state. The applicable subheading for Ularitide Acetate, imported in bulk form, will be 2937.19.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for "Polypeptide hormones, protein hormones and glycoprotein hormones, their derivatives and structural analogues: other”. The rate of duty will be free. The applicable subheading for MTP-PE,Na (Chemical Name – L-Alaninamide, H-(N-Acetylmuramoyl)-L-Alanyl-D-Alpha-Glutaminyl-N-[(7R)-4-Hydroxy-4-Oxido-10-Oxo-7-{(1-Oxohexadecyl)Oxy]-3,5,9-Trioxa-4-Phospha- pentacos-1-YL]-, Monosodium Salt, Hydrate) will be 2924.19.1050, Harmonized Tariff Schedule of the United States (HTS), which provides for acyclic amides (including acyclic carbamates) and their derivatives; salts thereof: other: amides… other. The rate of duty will be 3.7 percent ad valorem. The applicable subheading for PSN 357 AB will be 2933.39.6190, Harmonized Tariff Schedule of the United States (HTS), which provides for heterocyclic compounds with nitrogen hetero-atom(s) only: compounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure: other. The rate of duty will be 6.5 percent ad valorem.    This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which are administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 1-888-443-6332. 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 Andrew Stone at 646-733-3032. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division

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