The country of origin of Felbamate Tablets USP, in dosage form

N360976May 15, 2026OT:RR:NC:N3:138
CATEGORY: OriginPrakash RajendranViona Pharmaceuticals Inc.20 Commerce Drive, Suite 340Cranford, NJ 07016RE: The country of origin of Felbamate Tablets USP, in dosage formDear Mr. Rajendran:In your letter dated
April 23, 2026
, you requested a country of origin ruling on Felbamate TabletsUSP, in dosage form.Felbamate, imported in 400 mg and 600 mg tablets, is an antiepileptic agent. It is indicated for the treatmentof partial seizures with and without generalization in adults and partial and generalized seizures associatedwith Lennox-Gastaut syndrome in children.You stated that the active pharmaceutical ingredient (API), Felbamate, is manufactured in India and that thefinished tablets in dosage form are also made in India. In India, Felbamate will be mixed with variousinactive ingredients to produce the final Felbamate Tablets USP 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, the active ingredient Felbamate is made in India and the mixing of the API with the inactiveingredients into the final tablets is also made in India. Therefore, we find the country of origin of theFelbamate Tablets USP in dosage form 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