CLA-2-29:OT:RR:NC:N2:238
Ms. Inge Forstenzer
Ren-Pharm International, Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753
RE: The tariff classification of Lapatinib Ditosylate (CAS-388082-78-8) and Nilotinib Hydrochloride monohydrate (CAS-923288-90-8) in bulk form, from China
Dear Ms. Forstenzer:
In your letter dated September 3, 2009, you requested a tariff classification ruling.
The first product, Lapatinib Ditosylate, is an antineoplastic drug indicated for use in patients with advanced metastatic breast cancer.
The second product, Nilotinib Hydrochloride monohydrate, is a signal transduction inhibitor of the Bcr-Abl kinase, c-kit and Platelet Derived Growth Factor (PDGF). It is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant or intolerant to prior therapy that included imatinib.
The applicable subheading for the Lapatinib Ditosylate in bulk form will be 2934.99.3000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Aromatic or modified aromatic: Other: Drugs.” The rate of duty will be 6.5 percent ad valorem. At the present time, the suffix “ditosylate” is not listed in Table 2 of the Pharmaceutical Appendix to the Tariff Schedule. General Note 13, HTSUS, noted.
The applicable subheading for the Nilotinib Hydrochloride monohydrate in bulk form will be 2933.59.5300, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing a pyrimidine ring (whether or not hydrogenated) or piperazine ring in the structure: Other: Drugs: Aromatic or modified aromatic: Other.” The rate of duty will be 6.5% ad valorem.
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