The country of origin of Nitroglycerin Sublingual Tablets USP

N333664 July 18, 2023 OT:RR:NC:N3:138 CATEGORY: Origin Madhur Singhal Mankind Pharma Limited 208, Okhla Industrial Estate, Phase-3New Delhi 110020India RE:  The country of origin of Nitroglycerin Sublingual Tablets USP Dear Mr. Singhal: In your letter dated June 23, 2023, you requested a country of origin ruling on Nitroglycerin Sublingual Tablets USP.   Nitroglycerin Sublingual Tablet is a medicinal preparation containing Diluted Nitroglycerin, a vasodilator, as the active ingredient.  It is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.  Nitroglycerin Sublingual Tablets will be imported in dosages of 0.3 mg, 0.4 mg and 0.6 mg.  Nitroglycerin is also known as Glyceryl Trinitrate (GTN).  In your letter, you stated Diluted Nitroglycerin is a mixture of Glyceryl Trinitrate 2% in Lactose Monohydrate.   You stated that the active pharmaceutical ingredient (API), Diluted Nitroglycerin USP, is manufactured in Italy and that the finished Nitroglycerin Sublingual Tablets are made in India.  In India, the Diluted Nitroglycerin will be mixed with various inactive ingredients to produce the final Nitroglycerin Sublingual 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, Diluted Nitroglycerin (made in Italy), with the inactive ingredients into the final dosage Nitroglycerin Sublingual 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 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 Judy Lee at [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division