The country of origin of Tobramycin Inhalation Solution USP in dosage form

N331991 April 28, 2023 OT:RR:NC:N3:138 CATEGORY: Origin Madhur Singhal Mankind Pharma Limited 208, Okhla Industrial EstateNew Delhi, 110020India RE: The country of origin of Tobramycin Inhalation Solution USP in dosage form Dear Mr. Singhal: In your letter dated April 4, 2023, you requested a country of origin ruling on Tobramycin Inhalation Solution. Tobramycin Inhalation Solution USP, imported in 300 mg/5 mL (60 mg/mL), is an aminoglycoside antibiotic.  It is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa. You stated that the active pharmaceutical ingredient (API), Tobramycin, is manufactured in Hungary and that the finished Tobramycin Inhalation Solution is made in India.  In India, Tobramycin will be mixed with various inactive ingredients to produce the final Tobramycin 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 Tobramycin (made in Hungary) with the inactive ingredients into the final dosage Tobramycin Inhalation Solution in India does not result in a substantial transformation and the country of origin will be Hungary. 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