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NY N023108




February 14, 2008

CLA-2-30:OT:RR:NC:2:238

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.90.9130; 3004.90.9135

Mr. Pradeep Shah
Zydus Pharmaceuticals (USA) Inc.
210 Carnegie Center, Suite 103
Princeton, NJ 08540

RE: The tariff classification of Alprazolam Extended Release (ER) Tablets (0.5 mg, 1 mg, 2 mg and 3 mg), Risperidone Tablets (0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg), Risperidone Orally Disintegrating Tablets (0.5 mg, 1 mg and 2 mg), and Venlafaxine HCL Tablets (25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg) from India

Dear Mr. Shah:

In your letter dated January 9, 2008, resubmitted on February 8, 2008, you requested a tariff classification ruling.

Alprazolam in Extended Release Tablet form is a medicinal preparation, in dosage form, based on a sedative-hypnotic drug used in the treatment of anxiety and panic disorders.

Risperidone in Tablet form and Orally Disintegrating Tablet form is a medicinal preparation, in dosage form, based on a psychotropic agent indicated for the treatment of schizophrenia.

Venlafaxine HCL in Tablet form is a medicinal preparation, in dosage form, based on an antidepressant drug indicated for the treatment of major depressive disorder.

The applicable subheading for the Alprazolam ER Tablets will be 3004.90.9130, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the central nervous system: Anticonvulsants, hypnotics and sedatives." The rate of duty will be free.

The applicable subheading for the Risperidone Tablets, Risperidone Orally Disintegrating Tablets and the Venlafaxine HCL Tablets will be 3004.90.9135 which provides for "Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the central nervous system: Antidepressants, tranquilizers, and other psychotherapeutic agents." 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/.

Alprazolam ER Tablets 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.

Risperidone Tablets and Venlafaxine HCL Tablets 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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