The tariff classification of Fingolimod Capsules and Lurasidone Hydrochloride Tablets in dosage form, from India

N301732 November 30, 2018 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9215; 3004.90.9235 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Fingolimod Capsules and Lurasidone Hydrochloride Tablets in dosage form, from India Dear Mr. Shah: In your letter dated November 12, 2018, you requested a tariff classification ruling. Fingolimod, imported in 0.5 mg capsule form, is in a class of immune modulators known as sphingosine-1-phosphate receptor modulator. It is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in patients 10 years of age and older. Lurasidone Hydrochloride, imported in 20 mg, 40 mg, 60 mg 80 mg and 120 mg capsule form, is an atypical antipsychotic agent. It is indicated for the treatment of adult patients with schizophrenia and for the treatment of major depressive episodes associated with bipolar I disorder. The applicable subheading for Fingolimod Capsules in dosage form will be 3004.90.9215, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other: Other: Other: Antineoplastic and immunosuppressive medicaments.” The rate of duty will be free. The applicable subheading for Lurasidone Hydrochloride Tablets in dosage form will be 3004.90.9235, HTSUS, which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the central nervous system: Antidepressants, tranquilizers, and other psychotherapeutic agents.” 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 the World Wide Web at https://hts.usitc.gov/current. 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 Judy Lee at judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division