N185577 N1 Ruling Active

The tariff classification of Galantamine Hydrobromide tablets imported in dosage form, from India

Issued September 29, 2011 by U.S. Customs and Border Protection.

Tariff classification

HTS codes: 3004.40.0040

Headings: 3004

Product description

The subject product, Galantamine Hydrobromide is a medicinal preparation containing Galantamine Hydrobromide (CAS-1953-04-4), a competitive and reversible inhibitor of acetylcholinesterase, as the active ingredient. Galantamine Hydrobromide is a semisynthetic derivative of Galantamine, a naturally occurring alkaloid obtained from the Caucasian snowdrop Galanthus woronowii. It is indicated for the treatment of mild to moderate Alzheimer’s disease, vascular dementia and other memory impairments. In your letter,

CBP rationale

The applicable subheading for the Galantamine Hydrobromide tablets imported in measured dosage form will be 3004.40.0040, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration) or in forms or packings for retail sale: Containing alkaloids or derivatives thereof but not containing hormones, other products of heading 2937 or antibiotics: Other: Medicaments primarily affecting the central nervous system: Other.

Full text

N185577 September 29, 2011 CLA-2-30:OT:RR:NC:N2:237 CATEGORY: Classification TARIFF NO.: 3004.40.0040 Mr. Pradeep Shah Director, Supply Chain Zydus Pharmaceuticals USA, Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Galantamine Hydrobromide tablets imported in dosage form, from India Dear Mr. Shah: In your letter dated September 8, 2011, you requested a tariff classification ruling. The subject product, Galantamine Hydrobromide is a medicinal preparation containing Galantamine Hydrobromide (CAS-1953-04-4), a competitive and reversible inhibitor of acetylcholinesterase, as the active ingredient. Galantamine Hydrobromide is a semisynthetic derivative of Galantamine, a naturally occurring alkaloid obtained from the Caucasian snowdrop Galanthus woronowii. It is indicated for the treatment of mild to moderate Alzheimer’s disease, vascular dementia and other memory impairments. In your letter, you state it will be imported in measured dosage form in 4 mg, 8 mg and 12 mg tablets. The applicable subheading for the Galantamine Hydrobromide tablets imported in measured dosage form will be 3004.40.0040, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration) or in forms or packings for retail sale: Containing alkaloids or derivatives thereof but not containing hormones, other products of heading 2937 or antibiotics: Other: Medicaments primarily affecting the central nervous system: Other.” 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 Judy Lee at (646) 733-3033. Sincerely, Robert B. Swierupski Director National Commodity Specialist Division

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