The tariff classification and country of origin of Dipyridamole Tablets USP in dosage form

N323733 February 15, 2022 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification; Country of Origin TARIFF NO.: 3004.90.9220 Mr. Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification and country of origin of Dipyridamole Tablets USP in dosage form Dear Mr. Shah: In your letter dated January 18, 2022, you requested a tariff classification and country of origin ruling. Dipyridamole, imported in 25 mg, 50 mg, and 75 mg tablets, is a platelet inhibitor. It is indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement. The applicable subheading for the Dipyridamole Tablets in dosage form will be 3004.90.9220, 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: Cardiovascular medicaments.” 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. You also requested a country of origin ruling. You stated that the active pharmaceutical ingredient (API), Dipyridamole, is manufactured in Italy and that the finished Dipyridamole Tablets in dosage form are made in India. In India, the Dipyridamole will be mixed with various inactive ingredients to produce the final Dipyridamole Tablets in dosage form. Section 134.1(b), Customs Regulations (19 CFR 134.1(b)), defines "country of origin" as: The country of manufacture, production, or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the "country of origin" within the meaning of this part; …. A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact. See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and National Juice Products Association v. United States, 628 F. Supp. 978 (Ct. Int’l Trade 1986). In this case, we find the mixing of the active ingredient Dipyridamole (made in Italy) with the inactive ingredients into the final dosage Dipyridamole Tablets in India does not result in a substantial transformation and the country of origin will be Italy. 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