The country of origin of Ofloxacin Ophthalmic Solution USP, 0.3 % in dosage form

N327945 September 21, 2022 CLA-2:OT:RR:NC:N3:138 CATEGORY: Country of Origin Mr. Rajender Singh Mankind Pharma Limited 208, Okhla Industrial Estate, Phase-3, New Delhi, 110020 India RE: The country of origin of Ofloxacin Ophthalmic Solution USP, 0.3 % in dosage form Dear Mr. Singh: In your letter dated August 31, 2022, you requested a country of origin ruling determination on Ofloxacin Ophthalmic Solution.Ofloxacin Ophthalmic Solution is an antibacterial agent containing Ofloxacin, as the active ingredient. It is indicated for the treatment of conjunctivitis and corneal ulcers caused by various strains of gram-positive and gram-negative bacteria. You stated that the active pharmaceutical ingredient (API), Ofloxacin, is manufactured in Spain and that the finished Ofloxacin Ophthalmic Solution in dosage is made in India. In India, the Ofloxacin will be mixed with various inactive ingredients to produce the final Ofloxacin Ophthalmic 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 Ofloxacin (made in Spain) with the inactive ingredients into the final Ofloxacin Ophthalmic Solution in dosage form 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 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 judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division