Ms. Inge Forstenzer
Ren-Pharm International, Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753
RE: The tariff classification of Anidulafungin (CAS-166663-25-8), Micafungin Sodium (CAS-208538-73-2), and Everolimus (CAS-159351-69-6)
Dear Ms. Forstenzer:
In your letter dated July 1, 2009, you requested a tariff classification ruling.
The first product, Anidulafungin, is a semi-synthetic lipopeptide synthesized from a fermentation product of Aspergillus nidulans. Anidulafungin is in a class of antifungal drugs known as echinocandin. It is indicated for the treatment of fungal infections, especially Candida infections.
The second product, Micafungin Sodium, is also an antifungal drug and is synthesized from a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1, 3-ß-D-glucan, an integral component of the fungal cell wall. It is indicated for the treatment of patients with Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses.
The last product, Everolimus, is a semisynthetic derivative of Rapamycin, currently known as Sirolimus. It is an mTor inhibitor and is currently used as an immunosuppressant to prevent rejection of organ transplants as well as for the treatment of advanced kidney cancer.
The applicable subheading for the Anidulafungin and Micafungin Sodium in bulk form will 2941.90.3000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Antibiotics: Other: Other: Aromatic or modified aromatic.” The rate of duty will be free.
The applicable subheading for Everolimus, imported in bulk form, will be 2941.90.5000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Antibiotics: Other: Other: 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.
Robert B. Swierupski
National Commodity Specialist Division