The country of origin of ZYMFENTRA™ (Infliximab-dyyb) Injection

N352591
September 18, 2025
OT:RR:NC:N3:138
CATEGORY: Origin Seungeun Jeong Celltrion 19, Academy-ro 51beon-gil, Yeonsu-gu Incheon 22014 South Korea RE: The country of origin of ZYMFENTRA™ (Infliximab-dyyb) Injection Dear Seungeun Jeong: In your letter dated August 19, 2025, you requested a country of origin ruling on ZYMFENTRA (Infliximab-dyyb) Injection, for subcutaneous use. ZYMFENTRA™ (Infliximab-dyyb) Injection, contains Infliximab-dyyb, a chimeric IgG1 monoclonal antibody, as the active pharmaceutical ingredient (API). Zymfentra is a tumor necrosis factor (TNF) blocker indicated for adult patients with moderately to severely active ulcerative colitis or Crohn’s disease. It is administered subcutaneously (under the skin) following an induction period with infliximab delivered via intravenous (IV) infusion. Zymfentra will be imported in 120 mg/mL in a single-dose prefilled syringe; 120 mg/mL in a single-dose prefilled syringe with needle guard; and 120 mg/mL in a single-dose prefilled auto-injector pen. In your letter, you requested a country of origin determination and indicated the active pharmaceutical ingredient (API) is also known as the drug substance (DS). You stated that the API or DS, is manufactured in Singapore and mixed with various inactive ingredients to obtain the final formulation. Afterwards, in Germany, the formulated DS will be filled into syringes and auto-injector pens to produce the final drug in dosage form. You stated that no additional excipients or other substances are introduced during the processing performed in Germany. Subsequently, in South Korea, the pre-filled syringes and auto-injector pens will be labeled and packaged, resulting in the finished drug product (fDP) in dosage form. This fDP will then be imported into the United States. 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, we find the processing performed in Germany and South Korea does not result in a substantial transformation and the country of origin will be Singapore, where the API is made. 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 [email protected].
Sincerely,
(for) Denise Faingar Acting Director National Commodity Specialist Division