The country of origin of Diltiazem Hydrochloride Extended-Release Capsules in dosage form

N353418 October 2, 2025 OT:RR:NC:N3:138 CATEGORY: Origin Lisa Murrin Expeditors Tradewin LLC 795 Jubilee Drive Peabody, MA 01960 RE: The country of origin of Diltiazem Hydrochloride Extended-Release Capsules in dosage form Dear Ms. Murrin: In your letter dated September 8, 2025, on behalf of Ingenus Pharmaceuticals, LLC, you requested a country of origin ruling. Diltiazem Hydrochloride, imported in 120 mg, 180 mg, 240 mg, 300 mg and 360 mg extended-release capsules, is a medicinal preparation containing, Diltiazem Hydrochloride, as the active ingredient. It is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist) indicated for the treatment of hypertension and angina. In your letter, you stated Diltiazem Hydrochloride is manufactured in Italy and the finished capsules in dosage form are made in China. In China, the Diltiazem Hydrochloride will be mixed with various inactive ingredients to produce the final Diltiazem Hydrochloride extended-release capsules 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 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 mixing of the active ingredient Diltiazem Hydrochloride (made in Italy) with the inactive ingredients into the final extended-release capsules in dosage form in China does not result in a substantial transformation and the country of origin will be Italy. 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 judy.h.lee@cbp.dhs.gov. Sincerely, (for) Denise Faingar Designated Official Performing the Duties of the Division Director National Commodity Specialist Division