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NY M83428




May 18, 2006

CLA-2-29:RR:NC:2:238 M83428

CATEGORY: CLASSIFICATION

TARIFF NO.: 2934.99.3000; 2933.49.2600; 2933.99.5300

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

RE: The tariff classification of Rotigotine (CAS-99755-59-6), Efavirenz (CAS-154598-52-4), Montelukast Sodium (CAS-151767-02-1) and Telmisartan (CAS-144701-48-4), imported in bulk form, from Italy

Dear Ms. Forstenzer:

In your letter dated May 4, 2006, you requested a tariff classification ruling.

The first product, Rotigotine, is an investigational new drug for the treatment of Parkinson’s disease. According to a press release found on the World Wide Web, a New Drug Application (NDA) for Rotigotine was filed with the U.S. Food & Drug Administration (FDA) in January 2005.

The second product, Efavirenz, is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection.

The third product, Montelukast Sodium, is indicated for the prevention and treatment of asthma, and is also indicated for the relief of the symptoms (sneezing, runny nose, itching, wheezing) of seasonal allergies.

The fourth product, Telmisartan, is indicated for the treatment of hypertension.

Pursuant to the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research, published in the Customs Bulletin, Volume 34, No. 21, dated May 24, 2000, the applicable subheading for Rotigotine, imported 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 rate of duty will be 6.5 percent ad valorem

At the present time, Rotigotine is not listed in the Pharmaceutical Appendix to the Tariff Schedule, HTSUS..

The applicable subheading for Efavirenz, imported in bulk form, will be 2934.99.3000, 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 Montelukast Sodium, imported in bulk form, will be 2933.49.2600, HTSUS, which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing in the structure a quinoline or isoquinoline ring (whether or not hydrogenated), not further fused: Other: Other Drugs: Other.” Pursuant to General Note 13, HTSUS, the rate of duty will be free.

The applicable subheading for Telmisartan, imported in bulk form, will be 2933.99.5300, 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 Harvey Kuperstein at 646-733-3033.

Sincerely,

Robert B. Swierupski

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