OT:RR:NC:N3:138
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