CLA-2-30:OT:RR:NC:N2:238
Ms. Zenaida Rodriguez
IPR Pharmaceuticals, Inc.
P.O. Box 1624
Canovanas, PR 00729-1624
RE: The tariff classification of AZD1656 in bulk form, from Sweden
Dear Ms. Rodriguez:
In your letter dated July 20, 2010, you requested a tariff classification ruling.
The subject product, AZD1656, is a glucokinase activator (GCA) compound being formulated and developed as an oral glucose lowering agent. Currently, it is undergoing Phase II clinical studies for the treatment of Type 2 Diabetes Mellitus. You state in your letter, AZD1656 will be mixed with Sodium Lauryl Sulphate and Mannitol to facilitate the manufacturing process by minimizing adherence of the material to the equipment wall. It will be formulated as an immediate release tablet for b.i.d. administration. The Investigational New Drug (IND) number is 76,507 with the CAS number 919783-22-5.
Pursuant to the General Notice entitled Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research (see Customs Bulletin and Decisions, dated May 24, 2000), the applicable subheading for AZD1656 mixed with other constituents for therapeutic or prophylactic use will be 3003.90.0000, Harmonized Tariff Schedule, which provides for “Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale: 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 Harvey Kuperstein at (646) 733-3033.
Sincerely,
Robert B. Swierupski
Director
National Commodity Specialist Division