N316117 N3 Ruling Active

The tariff classification of Desvenlafaxine Extended Release Tablets and Mesalamine Extended Release Capsules from India

Issued December 16, 2020 by U.S. Customs and Border Protection.

Tariff classification

HTS codes: 3004.90.9235, 3004.90.9260

Headings: 3004

Product description

Desvenlafaxine, imported in 25 mg, 50 mg and 100 mg extended release tablets, is a medicinal preparation containing Desvenlafaxine Succinate, a serotonin-norepinephrine reuptake inhibitor (SNRI), as the active ingredient. It is indicated for the treatment of adults with major depressive disorder (MDD). Mesalamine, imported in 375 mg extended release capsules, is a medicinal preparation containing Mesalamine, an aminosalicylate, as the active ingredient. It is indicated for the treatment of ulcerative colitis.

CBP rationale

The applicable subheading for the Desvenlafaxine Extended Release Tablets in dosage form will be 3004.90.9235, 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: Medicaments primarily affecting the central nervous system: Antidepressants, tranquilizers, and other psychotherapeutic agents. The applicable subheading for the Mesalamine Extended Release Capsules in dosage form will be 3004.90.9260, 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 digestive system: Other.

Full text

N316117 December 16, 2020 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9235; 3004.90.9260 Mr. Pradeep R. Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Desvenlafaxine Extended Release Tablets and Mesalamine Extended Release Capsules from India Dear Mr. Shah: In your letter dated November 25, 2020, you requested a tariff classification ruling. Desvenlafaxine, imported in 25 mg, 50 mg and 100 mg extended release tablets, is a medicinal preparation containing Desvenlafaxine Succinate, a serotonin-norepinephrine reuptake inhibitor (SNRI), as the active ingredient. It is indicated for the treatment of adults with major depressive disorder (MDD). Mesalamine, imported in 375 mg extended release capsules, is a medicinal preparation containing Mesalamine, an aminosalicylate, as the active ingredient. It is indicated for the treatment of ulcerative colitis. The applicable subheading for the Desvenlafaxine Extended Release Tablets in dosage form will be 3004.90.9235, 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: Medicaments primarily affecting the central nervous system: Antidepressants, tranquilizers, and other psychotherapeutic agents.” The rate of duty will be free. The applicable subheading for the Mesalamine Extended Release Capsules in dosage form will be 3004.90.9260, 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 digestive system: 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 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 [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division

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