The country of origin of Estradiol Gel 0.1%, in dosage form

N361498 May 19, 2026OT:RR:NC:N3:138 CATEGORY: OriginKamesh VenugopalEncube Ethicals, Inc.200 Meredith DriveDurham, NC 27713RE: The country of origin of Estradiol Gel 0.1%, in dosage formDear Mr. Venugopal:In your letter dated May 13, 2026 , you requested a country of origin ruling on Estradiol Gel, in dosage 0.1%form.Estradiol Gel 0.1%, imported in 0.25 g, 0.50 g, 0.75 g, 1.0 g, and 1.25 g, is a medicinal preparationcontaining estradiol hemihydrate, an estrogen receptor agonist, as the active ingredient. It is indicated for thetreatment of moderate to severe vasomotor symptoms due to menopause.You stated that the active pharmaceutical ingredient (API), estradiol hemihydrate, is manufactured in theNetherlands and that the finished gel in dosage form is made in India. In India, estradiol hemihydrate will bemixed with various inactive ingredients to produce the final Estradiol Gel 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 asubstantial 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 mixing of the active ingredient estradiol hemihydrate (made in the Netherlands) withthe inactive ingredients into the final Estradiol Gel in dosage form in India does not result in a substantialtransformation and the country of origin will be the Netherlands.You also submitted pictures of the labels for our review. Based upon the labels provided, the subject productdoes not appear to be legally marked with the proper country of origin. The labels state the product ismanufactured in India. However, the country of origin is the Netherlands where the API is made and shouldbe marked “Made in”, “Product of,” or other words of similar meaning with “Netherlands” as the country oforigin. This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public HealthSecurity and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which areadministered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, andCosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or byvisiting their website at www.fda.gov.The holding set forth above applies only to the specific factual situation and merchandise description asidentified 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 theinformation furnished in the ruling letter, whether directly, by reference, or by implication, is accurate andcomplete in every material respect. In the event that the facts are modified in any way, or if the goods do notconform to these facts at time of importation, you should bring this to the attention of U.S. Customs andBorder 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 periodicverification by CBP.This ruling is being issued under the provisions of Part 177 of the Customs and Border ProtectionRegulations (19 C.F.R. 177).A copy of the ruling or the control number indicated above should be provided with the entry documentsfiled at the time this merchandise is imported. If you have any questions regarding the ruling, please contactNational Import Specialist Judy Lee at judy.h.lee@cbp.dhs.gov. Sincerely, (for)James P. ForkanDirectorNational Commodity Specialist Division