RE: The country of origin of Valsartan and Hydrochlorothiazide Tablets USP, in dosage form

U.S. Department of Homeland Security U.S. Customs and Border Protection National Commodity Specialist Division One World Trade Center, Suite 51.201 New York, NY 10007 U.S. Customs and Border Protection N364380 September 9, 2026 OT:RR:NC:N3:138 CATEGORY: Origin Prakash Rajendran Viona Pharmaceuticals Inc. 20 Commerce Drive, Suite 340 Cranford 07016 RE: The country of origin of Valsartan and Hydrochlorothiazide Tablets USP, in dosage form Dear Mr. Rajendran: In your letter dated August 18, 2026, you requested a country of origin ruling on Valsartan and Hydrochlorothiazide Tablets USP, in dosage form. Valsartan and Hydrochlorothiazide, imported in various dosages in tablet form, is a medicinal preparation containing Valsartan (an angiotensin II receptor blocker) and Hydrochlorothiazide (a thiazide diuretic), as the active ingredients. It is indicated for the treatment of hypertension to lower blood pressure. You stated that the active pharmaceutical ingredients (APIs), Valsartan and Hydrochlorothiazide, are manufactured in China and India, respectively. In India, these two APIs will be mixed with various inactive ingredients to produce the final Valsartan and Hydrochlorothiazide Tablets 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 determining whether a substantial transformation occurs in the manufacture of chemical products such as pharmaceuticals, CBP has consistently examined the complexity of the processing and whether the final article retains the essential identity and character of the raw material. To that end, CBP has generally held that the processing of pharmaceutical products from bulk form into measured doses does not result in a substantial transformation of the product. See, e.g., Headquarters Ruling (“HQ”) 561975, dated April 3, 2002; HQ 561544, dated May 1, 2000; HQ 735146, dated November 15, 1993; HQ H267177, dated November 5, 2016; HQ H233356, dated December 26, 2012; and, HQ 561975, dated April 3, 2002.
However, where the processing from bulk form into measured doses involves the combination of two or more APIs, and the resulting combination offers additional medicinal benefits compared to taking each API alone, CBP has held that a substantial transformation occurred. See, e.g., HQ 563207, dated June 1, 2005. In this case, we note that the two separate APIs are mixed to create a combination drug that offers additional medicinal benefits compared to taking each API alone. Therefore, we find the mixing of the active ingredients, Valsartan and Hydrochlorothiazide with the inactive ingredients into the final dosage tablets in India results in a substantial transformation and the country of origin will be 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 [email protected]. Sincerely, (for) James P. Forkan Director National Commodity Specialist Division