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

N358260 February 24, 2026 OT:RR:NC:N3:138 CATEGORY: Origin Prakash Rajendran Viona Pharmaceuticals, Inc. 20 Commerce Drive, Suite 340 Cranford, NJ 07016 RE: The country of origin of Bicalutamide Tablets USP, in dosage form Dear Mr. Rajendran: In your letter dated January 27, 2026, you requested a country of origin ruling on Bicalutamide Tablets USP, in dosage form. Bicalutamide, imported in 50 mg tablet form, is an androgen receptor inhibitor. It is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of stage D2 metastatic carcinoma of the prostate. You stated that the active pharmaceutical ingredient (API), Bicalutamide is manufactured in India and that the finished tablets in dosage form are also made in India. In India, the Bicalutamide will be mixed with various inactive ingredients to produce the final Bicalutamide 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 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, the active ingredient Bicalutamide is made in India and the mixing of the API with the inactive ingredients into the final tablets is also made in India. Therefore, we find the country of origin of the Bicalutamide Tablets in dosage form will be India, where the API is made. 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) James Forkan Designated Official Performing the Duties of the Division Director National Commodity Specialist Division