OT:RR:NC:N3:138
Kamesh Venugopal
Encube Ethicals, Inc.
200 Meredith Drive
Durham, NC 27713
RE: The country of origin of Tacrolimus Ointment 0.1 % in dosage form, from India
Dear Mr. Venugopal:
In your letter dated April 2, 2025, you requested a country of origin ruling on Tacrolimus Ointment 0.1%.
Tacrolimus Ointment 0.1%, imported in 30 g, 60 g and 100 g, is a macrolide immunosuppressant produced
by Streptomyces tsukubaensis. It is indicated as second-line therapy for the short-term and non-continuous
chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults who have
failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those
treatments are not advisable.
You indicated that the active pharmaceutical ingredient (API), Tacrolimus, is manufactured in India and that
the finished Tacrolimus Ointment in dosage form is also made in India. In India, the Tacrolimus will be
mixed with various inactive ingredients to produce the final Tacrolimus Ointment 0.1 % in dosage form.
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 Tacrolimus is made in India and the mixing of the API with the inactive
ingredients into the final ointment is also made in India. We find the country of origin of the Tacrolimus
Ointment 0.1 % in dosage form will be India, 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,
Steven A. Mack
Director
National Commodity Specialist Division