The tariff classification of Dexlansoprazole Sesquihydrate (CAS-313640-86-7), Dexlansoprazole Amorphous (CAS-138530-94-6) and Dexlansoprazole Anhydrous (CAS-138530-94-6) in bulk form, from Italy

N061236 May 29, 2009 CLA-2-29:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 2933.39.4100 Ms. Inge Forstenzer Ren-Pharm International Ltd. 350 Jericho Turnpike, Suite 204 Jericho, NY 11753 RE: The tariff classification of Dexlansoprazole Sesquihydrate (CAS-313640-86-7), Dexlansoprazole Amorphous (CAS-138530-94-6) and Dexlansoprazole Anhydrous (CAS-138530-94-6) in bulk form, from Italy Dear Ms. Forstenzer: In your letter dated May 14, 2009, you requested a tariff classification ruling. The subject products, Dexlansoprazole Sesquihydrate, Dexlansoprazole Amorphous and Dexlansoprazole Anhydrous are the first proton pump inhibitor (PPI) with a Dual Delayed Release™ (DDR) formulation. PPI works by reducing acid productions in the stomach. It is indicated for the treatment of heartburn associated with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD), as well as for the treatment and maintenance of patients with Erosive Esophagitis. The applicable subheading for the Dexlansoprazole Sesquihydrate, Dexlansoprazole Amorphous and Dexlansoprazole Anhydrous 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: Compounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure: Other: Other: Drugs: Other.” Pursuant to GN13, 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 Director National Commodity Specialist Division