The country of origin of Amlodipine and Atorvastatin Tablets USP, in dosage form

N363341August 11, 2026OT:RR:NC:N3:138
CATEGORY: OriginPrakash RajendranViona Pharmaceuticals Inc.20 Commerce Drive, Suite 340Cranford, NJ 07016RE: The country of origin of Amlodipine and Atorvastatin Tablets USP, in dosage formDear Mr. Rajendran:In your letter dated
July 15, 2026
, you requested a country of origin ruling on Amlodipine and AtorvastatinTablets in dosage form.Amlodipine and Atorvastatina Amlodipine Tablets imported in various dosages consist of combination ofBesylate (calcium channel blocker) and Atorvastatin Calcium (HMG-CoA reductase inhibitor), as the activeingredients.It is indicated for the treatment of high blood pressure and high cholesterol. You stated that the active pharmaceutical ingredients (APIs), Amlodipine Besylateand Atorvastatin Calcium are anufactured in India. In India, these two APIs will be mixed with various inactive ingredients tomproduce the final Amlodipine and Atorvastatin 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 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 exas Instruments Inc. v.T, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993)ational Hand Tool Corp. v. United StatesN.In determining whether a substantial transfoation occurs in the manufacture of chemical products such asrmpharmaceuticals, CBP has consistently examined the complexity of the processing and whether the finalarticle 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., HQ 561975, dated April 3, 2002; HQ 561544, dated May1, 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 combinationoffers additional medicinal benefits compared to taking each API alone, CBP has held that a substantialtransformation 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. BAmlodipine Besylate and Atorvastatinoth APIs (Calcium with the inactive ingredients into the final dosage) are made in India and the mixingof the APIs tablets in IndiaAmlodipine and Atorvastatinalso occurs . Therefore, we find the country of origin of the Tablets i Indias.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