The tariff classification of Esomeprazole (CAS-119141-88-7) and Esomeprazole Magnesium (CAS-217087-09-7), imported in bulk form, from India

NY H89021 March 18, 2002 CLA-2-29:RR:NC:2:238 H89021 CATEGORY: Classification TARIFF NO.: 2933.39.4100 Mr. Michael R. Tartaro Byron Chemical Company, Inc. 40-11 23rd Street Long Island City, NY 11101 RE: The tariff classification of Esomeprazole (CAS-119141-88-7) and Esomeprazole Magnesium (CAS-217087-09-7), imported in bulk form, from India Dear Mr. Tartaro: In your letter dated March 6, 2002, you requested a tariff classification ruling. The first product, Esomeprazole, is the S - isomer of omeprazole, which is a mixture of the S - and R - isomers. Esomeprazole inhibits the secretion of gastric acid, and is indicated, inter alia, for the treatment of erosive esophagitis, brought on by Gastroesophageal Reflux Disease (GERD). The second product, Esomeprazole Magnesium, also known as esomeprazole magnesium trihydrate, is the hydrated magnesium salt of Esomeprazole. Like Esomeprazole, it is indicated, inter alia, for the treatment of erosive esophagitis, brought on by GERD. The applicable subheading for both products will be 2933.39.4100, Harmonized Tariff Schedule of the United States (HTS), 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. The rate of duty will be 6.5 percent ad valorem. We note that, at the present time, the name “Esomeprazole” is not listed in Table 1 of the Pharmaceutical Appendix to the Tariff Schedule. General Note 13, HTS. We further note that, at the present time, pursuant to General Note 4(b)(i) and 4(b)(ii), the subject products are ineligible for duty-free treatment under the Generalized System of Preferences (GSP).  This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544. 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