The country of origin of Mesalamine Rectal Suspension USP Enema 4 g/60 mL

N362236 July 7, 2026 OT:RR:NC:N3:138 CATEGORY: Origin Kamesh Venugopal Encube Ethicals, Inc. 200 Meredith Drive Durham, NC 27713 RE: The country of origin of Mesalamine Rectal Suspension USP Enema 4 g/60 mL Dear Mr. Venugopal: In your letter dated June 11, 2026, you requested a country of origin ruling on Mesalamine Rectal Suspension USP Enema 4 g/60 mL. Mesalamine Rectal Suspension USP Enema, imported in 60 mL unit dose bottles, is a medicinal preparation containing 4 grams of Mesalamine, as the active ingredient. It is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults. You stated that the active pharmaceutical ingredient (API), Mesalamine, is manufactured in India and that the finished rectal suspension is also made in India. In India, the Mesalamine will be mixed with various inactive ingredients to produce the final Mesalamine Rectal Suspension USP Enema. When determining the country of origin, the substantial transformation analysis is applicable. See, e.g., Headquarters Ruling Letter (“HQ”) H301619, dated November 6, 2018. The test for determining whether a substantial transformation will occur is whether an article emerges from a process with a new name, character, or use different from that possessed by the article prior to processing. See Texas Instruments Inc. v. United States, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993). In this case, the active ingredient Mesalamine is made in India and the mixing of the API with the inactive ingredients into the final Mesalamine Rectal Suspension USP Enema is also made in India. Therefore, we find the country of origin of the Mesalamine Rectal Suspension USP Enema in dosage form will be India, where the API is made. Please note that we previously issued a country of origin ruling letter (NY Ruling N336145, dated November 14, 2023) for the identical product, in which the active pharmaceutical ingredient (API) was manufactured in Sweden. In your most recent correspondence, you indicated that the API is now sourced from both Sweden and India. 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. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. 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, (for) James P. Forkan Director National Commodity Specialist Division