The country of origin of Formoterol Fumarate Inhalation Solution 20 mcg/2 mL

N330709 March 3, 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 Formoterol Fumarate Inhalation Solution 20 mcg/2 mL Dear Ms. Singhal: In your letter dated February 3, 2023, you requested a country of origin ruling for Formoterol Fumarate Inhalation Solution in dosage form. Formoterol Fumarate, imported in 20 mcg/2 mL inhalation solution, is a beta2-adrenergic bronchodilator.  It is indicated for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. You stated that the active pharmaceutical ingredient (API), Formoterol Fumarate, is manufactured in Italy and that the finished Formoterol Fumarate Inhalation Solution in dosage form is made in India. In India, the Formoterol Fumarate will be mixed with various inactive ingredients to produce the final Formoterol Fumarate Inhalation Solution 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 Formoterol Fumarate (made in Italy) with the inactive ingredients into the final Formoterol Fumarate Inhalation Solution in dosage form 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 judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division