The country of origin of Emtricitabine and Tenofovir Disoproxil Fumarate Tablets in dosage form

N363450August 13, 2026OT:RR:NC:N3:138
CATEGORY: OriginPradeep ShahZydus Pharmaceuticals USA Inc.73 Route 31 NorthPennington, NJ 08534RE: The country of origin of Emtricitabine and Tenofovir Disoproxil Fumarate Tablets in dosage formDear Mr. Shah:In your letter dated
July 20, 2026
, you requested a country of origin ruling on Emtricitabine and TeneofovirDisoproxil Fumarate Tablets.Emtricitabine and Tenofovir Disoproxil Fumarate, imported in 100 mg/150 mg, 133 mg/200 mg, 167 mg/250mg and 200 mg/300 mg tablets, is a combination antiviral medication belonging to a class of medicationscalled nucleotide reverse transcriptase inhibitors (NRTIs). It is indicated in combination with otherantiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17kg.You stated that the active pharmaceutical ingredients (APIs), EmtricitabineTenofovir Disoproxil and Fumarate are manufactured in India. In India, these two APIs will be mixed with various inactive ingredientsto produce the final Emtricitabine and Tenofovir Disoproxil Fumarate 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 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 aspharmaceuticals, 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. Both APIs (Emtricitabine and Tenofovir DisoproxilFumarate) are made in India and the mixing of the APIs with the inactive ingredients into the final dosagetablets also occurs in India. Therefore, we find the country of origin of the Emtricitabine and TenofovirDisoproxil Fumarate Tablets is 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