The country of origin of Norethindrone Acetate Tablets

N357931
July 23, 2026
OT:RR:NC:N3:138
CATEGORY: Origin Michael Gamble Expeditors Tradewin, LLC 795 Jubilee Drive Peabody, MA 01960 RE: The country of origin of Norethindrone Acetate Tablets Dear Mr. Gamble: In your letter dated January 19, 2026, on behalf of Ingenus Pharmaceuticals, LLC, you requested a country of origin ruling on Norethindrone Acetate Tablets. We apologize for the delay as the information was sent to the laboratory for analysis. Norethindrone Acetate, imported in 5 mg tablets, is a synthetic progestin hormone. It is indicated for the treatment of endometriosis, irregular menstrual cycles, and secondary amenorrhea. You stated that the active pharmaceutical ingredient (API), Norethindrone Acetate, is manufactured in France and that the finished tablets in dosage form is made in China. In China, the Norethindrone Acetate will be mixed with various inactive ingredients to produce the final Norethindrone Acetate 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 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 Norethindrone Acetate (made in France) with the inactive ingredients into the final dosage Norethindrone Acetate Tablets in China does not result in a substantial transformation and the country of origin will be France. 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) James P. Forkan Director National Commodity Specialist Division