The country of origin of Varenicline Tablets

N329963 January 18, 2023 OT:RR:NC:N3:138 CATEGORY: Origin Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 NorthPennington, NJ 08534 RE: The country of origin of Varenicline Tablets Dear Mr. Shah: In your letter dated December 21, 2022, you requested a country of origin ruling on Varenicline Tablets. Varenicline, imported in 0.5 mg and 1 mg tablets, is a medicinal preparation containing Varenicline Tartrate, a nicotinic receptor partial agonist, as the active ingredient.  It is available by prescription only for the treatment of nicotine dependency associated with smoking in adults. You stated that the active pharmaceutical ingredient (API),Varenicline Tartrate, is manufactured in Spain and that the finished Varenicline Tablets in dosage form are made in India.  In India, the Varenicline Tartrate will be mixed with various inactive ingredients to produce the final Varenicline 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 Varenicline Tartrate (made in Spain) with the inactive ingredients into the final dosage tablets in India does not result in a substantial transformation and the country of origin will be Spain. 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 and Border Protection 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, please contact National Import Specialist Judyt Lee at [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division