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NY M87168




October 11, 2006

CLA-2-29:RR:NC:2:238 M87168

CATEGORY: CLASSIFICATION

TARIFF NO.: 2933.99.5300; 2922.49.4050; 2933.79.0800

Ms. Inge Forstenzer
Ren-Pharm International, Ltd.
350 Jericho Turnpike, Suite 204
Jericho, New York 11753

RE: The tariff classification of Candesartan (CAS-139481-59-7), Pregabalin (CAS-148553-50-8), and Ezetimibe (CAS-163222-33-1), imported in bulk form, from Taiwan and Italy

Dear Ms. Forstenzer:

In your letter dated September 25, 2006, you requested a tariff classification ruling.

The first product, Candesartan, is indicated for the treatment of hypertension.

The second product, Pregabalin, is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and as adjunctive therapy for adult patients with partial onset seizures.

The third product, Ezetimibe, is indicated for use as an antihyperlipoproteinemic drug.

The applicable subheading for Candesartan, imported 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.

The applicable subheading for Pregabalin, imported in bulk form, will be 2922.49.4050, HTSUS, which provides for “Amino-acids, other than those containing more than one kind of oxygen function, and their esters, salts thereof: Other: Other: Amino acids: Other.” Pursuant to General Note 13, HTSUS, the rate of duty will be free.

The applicable subheading for Ezetimibe, imported in bulk form, will be 2933.79.0800, HTSUS, which provides for Heterocyclic compounds with nitrogen hetero-atom(s) only: Lactams: Other lactams: Aromatic or modified aromatic: Other: Products described in additional U.S. note 3 to section VI.” Pursuant to heading 9902.01.64, HTSUS, the rate of duty will be free, if imported on or before 12/31/06.

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/.

Candesartan and Ezetimibe 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.

Pregabalin may be subject to the requirements of the Controlled Substances Act, which are enforced by the U.S. Drug Enforcement Administration (DEA), Office of Diversion Control. You may contact them at 2401 Jefferson Davis Highway, Alexandria, VA 22301, telephone (800) 882-9539.

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 Harvey Kuperstein at 646-733-3033.

Sincerely,

Robert B. Swierupski

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