The country of origin of Candesartan Cilexetil and Hydrochlorothiazide Tablets USP, in dosage form

N361531May 21, 2026OT:RR:NC:N3:138
CATEGORY: OriginPrakash RajendranViona Pharmaceuticals Inc.20 Commerce Drive, Suite 340Cranford, NJ 07016RE: The country of origin of Candesartan Cilexetil and Hydrochlorothiazide TabletsUSP, in dosage form Dear Mr. Rajendran:In your letter dated
May 14, 2026
, you requested a country of origin ruling on Candesartan Cilexetil andHydrochlorothiazide Tablets USP, in dosage form.Candesartan Cilexetil and Hydrochlorothiazide, imported in 16 mg/12.5 mg, 32 mg/12.5 mg and 32 mg/25mg tablets, is a medicinal preparation containing Candesartan Cilexetil (an angiotensin II receptor blocker)and Hydrochlorothiazide (a diuretic), as the active ingredients. It is indicated for the treatment ofhypertension, to lower blood pressure.You stated that the active pharmaceutical ingredients (APIs), Candesartan Cilexetil and Hydrochlorothiazide,are manufactured in China and India, respectively. In India, these two APIs will be mixed with variousinactive ingredients to produce the final Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP indosage form.Section 134.1(b), Customs Regulations (19 CFR 134.1(b)), defines "country of origin" as:The country of manufacture, production or growth of any article of foreign origin entering the United States.Further work or material added to an article in another country must effect a substantial transformation inorder to render such other country the "country of origin" within the meaning of this part; ….A substantial transformation occurs when an article emerges from a process with a new name, character oruse different from that possessed by the article prior to processing. A substantial transformation will notresult from a minor manufacturing or combining process that leaves the identity of the article intact. SeeUnited States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and National Juice Products Association v.United States, 628 F. Supp. 978 (Ct. Int’l Trade 1986).In determining whether a substantial transformation occurs in the manufacture of chemical products such aspharmaceuticals, 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 heldthat the processing of pharmaceutical products from bulk form into measured doses does not result in asubstantial 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, datedNovember 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 moreAPIs, 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 additionalmedicinal benefits compared to taking each API alone. Therefore, we find the mixing of the activeingredients, Candesartan Cilexetil and Hydrochlorothiazide with the inactive ingredients into the final dosagetablets 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 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 [email protected].
Sincerely,
(for)James P. ForkanDirectorNational Commodity Specialist Division