The country of origin of Cyanocobalamin Injection in dosage form

N331994 May 2, 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 Cyanocobalamin Injection in dosage form Dear Mr. Singhal: In your letter dated April 4, 2023, you requested a country of origin ruling on Cyanocobalamin Injection. Cyanocobalamin Injection, imported in 1,000 mcg/mL and 10,000 mcg/10 mL (1,000 mcg/mL) multiple-dose vials is a synthetic form of Vitamin B12.  It is indicated for the treatment of Vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions: Addisonian (pernicious) anemia, gastrointestinal pathology, dysfunction, or surgery, including gluten sprue-like enteropathy, small bowel bacterial overgrowth, total or partial gastrectomy, fish tapeworm infestation, malignancy of the pancreas or bowel and folic acid deficiency. You stated that the active pharmaceutical ingredient (API), Cyanocobalamin, is manufactured in France and that the finished Cyanocobalamin Injection in dosage form is made in India.  In India, Cyanocobalamin will be mixed with various inactive ingredients to produce the final Cyanocobalamin Injection 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 Cyanocobalamin (made in France) with the inactive ingredients into the final Cyanocobalamin Injection in dosage form does not result in a substantial transformation and the country of origin will be France. 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