Ms. Inge Forstenzer
Ren-Pharm International Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753
RE: The tariff classification of Dexlansoprazole (CAS-138530-94-6) in bulk form, from Italy and Diacerein (CAS-13739-02-1) in bulk form, from India
Dear Ms. Forstenzer:
In your letter dated May 1, 2008, you requested a tariff classification ruling.
The first product, Dexlansoprazole, is a proton pump inhibitor and is currently in Phase III clinical trials. It is indicated for the treatment of erosive oesophagitis, Gastro-oesophageal reflux and Gastrointestinal disorders.
The second product, Diacerein (INN), also known as diacetylrhein, is a drug used in the treatment of osteoarthritis. It works by inhibiting interleukin-1.
The applicable subheading for the Dexlansoprazole 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: Other: Drugs: Other." Pursuant to General Note 13, HTS, the rate of duty will be free.
The applicable subheading for the Diacerein in bulk form will be 2918.99.3000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Carboxylic acids with additional oxygen function and their anhydrides, halides, peroxides and peroxyacids; their halogenated, sulfonated, nitrated or nitrosated derivatives: Other: Aromatic: Other: Drugs." Pursuant to General Note 13, HTS, 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.
Robert B. Swierupski