The tariff classification of Sitagliptin Phosphate Monohydrate (CAS No. 654671-77-9), Spironolactone (CAS No. 52-01-7) and Ticagrelor (CAS No. 274693-27-5) in bulk form, from India

N298223 July 16, 2018 CLA-2-29:OT:RR:NC:N1:138 CATEGORY: Classification TARIFF NO.: 2933.59.5300; 2937.29.9095 Mr. Gnanapragasam Louis Jeyaraj SST Corporation 635 Brighton Road Clifton, NJ 07012 RE: The tariff classification of Sitagliptin Phosphate Monohydrate (CAS No. 654671-77-9), Spironolactone (CAS No. 52-01-7) and Ticagrelor (CAS No. 274693-27-5) in bulk form, from India Dear Mr. Jeyaraj: In your letter dated June 22, 2018, you requested a tariff classification ruling. Sitagliptin Phosphate Monohydrate is an antidiabetic drug of the dipeptidyl peptidase-4 (DPP-4) inhibitor class. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Spironolactone is an aldosterone-receptor antagonist with diuretic, antihypertensive and antiandrogen activities. It is indicated for the management of primary hyperaldosteronism, congestive heart failure, essential hypertension, hypokalemia, heart failure and edema. Ticagrelor is a P2Y12 platelet inhibitor indicated to reduce the risk of myocardial infarction and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction (MI). In your letter, you indicated these drug substances will be used to develop a finished drug product formulation and will be imported in approximately 100 grams. The applicable subheading for the Sitagliptin Phosphate Monohydrate and the Ticagrelor 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.” Pursuant to General Note 13, HTSUS, the rate of duty will be free. The applicable subheading for the Spironolactone will be 2937.29.9095, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Steroidal hormones, their derivatives and structural analogues: 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 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