The country of origin of VIGADRONE® (Vigabatrin) for Oral Solution in dosage form

N352251
September 2, 2025
OT:RR:NC:N3:138
CATEGORY: Origin Lori Riggs Upsher-Smith Laboratories, LLC 6701 Evenstad Drive Maple Grove, MN 55369 RE: The country of origin of VIGADRONE® (Vigabatrin) for Oral Solution in dosage form Dear Ms. Riggs: In your letter dated August 11, 2025, you requested a country of origin ruling on VIGADRONE® (Vigabatrin) for Oral Solution. VIGADRONE (Vigabatrin) for Oral Solution, imported in 500 mg sachets, is a medicinal preparation containing Vigabatrin (anti-convulsant), as the active ingredient. It is indicated for the treatment of Refractory Complex Partial Seizures (CPS) and Infantile Spasms (IS). In your letter, you stated the active pharmaceutical ingredient (API) is manufactured in India and that the finished oral solution in dosage form is made in China. In China, the API will be directly filled into 500 mg sachets and packaged into cartons. You stated there are no additional inactive or active ingredients involved in the entire production process other than the API (Vigabatrin). 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 this case, we find the filling and packaging of the API (Vigabatrin) into the finished 500 mg sachets in dosage form in China does not result in a substantial transformation and the country of origin of the final VIGADRONE (Vigabatrin) for Oral Solution in dosage form 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) Denise Faingar Acting Director National Commodity Specialist Division