The tariff classification of Aliskiren Hemifumarate (CAS-173334-58-2) and Esomeprazole Magnesium (CAS-161973-10-0) in bulk form, from India

N043304 November 7, 2008 CLA-2-29:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 2924.29.6250; 2933.39.4100 Ms. Inge Forstenzer Ren-Pharm International Ltd. 350 Jericho Turnpike, Suite 204 Jericho, NY 11753 RE: The tariff classification of Aliskiren Hemifumarate (CAS-173334-58-2) and Esomeprazole Magnesium (CAS-161973-10-0) in bulk form, from India Dear Ms. Forestenzer: In your letter dated October 28, 2008, you requested a tariff classification ruling. The first product, Aliskiren Hemifumarate, is the first in a new class of drugs called non peptide renin inhibitors, and is used for the treatment of hypertension. The second product, Esomeprazole Magnesium, inhibits gastric acid secretion and is indicated for the treatment of Gastroesophageal Reflux Disease (GERD). The applicable subheading for the Aliskiren Hemifumarate in bulk form will be 2924.29.6250, Harmonized Tariff Schedule of the United States (HTSUS), which provides "Carboxyamide-function compounds; amide-function compounds of carbonic acid: Cyclic amides (including cyclic carbamates) and their derivatives; salts thereof: Other: Aromatic: Other: Drugs: Other: Other." The rate of duty will be 6.5% Ad Valorem. The applicable subheading for Esomeprazole Magnesium in bulk form will be 2933.39.4100, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure: Other: Drugs: Other.” Pursuant to GN 13, HTSUS, the rate of duty will be free. Articles classifiable under subheading 2924.29.6250, HTSUS, which are products of India may be entitled to duty free treatment under the Generalized System of Preferences (GSP) upon compliance with all applicable regulations. The GSP is subject to modification and periodic suspension, which may affect the status of your transaction at the time of entry for consumption or withdrawal from warehouse. To obtain current information on GSP, check our Web site at www.cbp.gov and search for the term "GSP". 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 Director National Commodity Specialist Division