N025217 N0 Ruling Active

The tariff classification of FDKP, imported in bulk form, from Switzerland

Issued April 22, 2008 by U.S. Customs and Border Protection.

Tariff classification

HTS codes: 2933.59.9500

Headings: 2933

Product description

FDKP is a mixture of isomers [R,R], [S,S], and [R,S] of the chemical compound 3,6-Bis(N-fumaryl-4-aminobutyl)-2,5-diketopiperazine, also known as 2-Butenoic acid, 4,4’-[(3,6-dioxo-2,5-piperazinediyl)bis(4,1-butanediylimino)]bis[4-oxo-, (2E,2’E)-. The CAS number for the isomeric mixture is 294659-59-9. The CAS number for the [S,S] isomer is 176738-91-3. Presently, no CAS numbers exist for the [R,R] and [S,R] isomers. The product, a pharmaceutical intermediate, is a component in the manufacture of Technosphere Insulin®, a drug used in the treatment of diabetes. Based on the chemical structure, the product is a nonaromatic heterocyclic compound with nitrogen hetero-atom(s) containing a piperazine ring.

CBP rationale

The applicable subheading will be 2933.59.9500, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Heterocyclic compounds with nitrogen hetero-atoms(s) only: Compounds containing a pyrimidine ring (whether or not hydrogenated) or piperazine ring in the structure: Other: Other: Other: Other.

Full text

N025217 April 22, 2008 CLA-2-29:OT:RR:E:NC:2:239 CATEGORY: Classification TARIFF NO.: 2933.59.9500 Ms. Lynn Kelleher MannKind Corporation 61 South Paramus Road Paramus, New Jersey 07652 RE: The tariff classification of FDKP, imported in bulk form, from Switzerland Dear Ms. Kelleher: In your letter dated March 25, 2008, you requested a tariff classification ruling for FDKP. FDKP is a mixture of isomers [R,R], [S,S], and [R,S] of the chemical compound 3,6-Bis(N-fumaryl-4-aminobutyl)-2,5-diketopiperazine, also known as 2-Butenoic acid, 4,4’-[(3,6-dioxo-2,5-piperazinediyl)bis(4,1-butanediylimino)]bis[4-oxo-, (2E,2’E)-. The CAS number for the isomeric mixture is 294659-59-9. The CAS number for the [S,S] isomer is 176738-91-3. Presently, no CAS numbers exist for the [R,R] and [S,R] isomers. The product, a pharmaceutical intermediate, is a component in the manufacture of Technosphere Insulin®, a drug used in the treatment of diabetes. Based on the chemical structure, the product is a nonaromatic heterocyclic compound with nitrogen hetero-atom(s) containing a piperazine ring. The applicable subheading will be 2933.59.9500, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Heterocyclic compounds with nitrogen hetero-atoms(s) only: Compounds containing a pyrimidine ring (whether or not hydrogenated) or piperazine ring in the structure: Other: Other: Other: Other. The rate of duty will be 6.5 percent ad valorem. 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 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 Richard Dunkel at 646-733-3032. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division

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