The tariff classification and country of origin of Javygtor (Sapropterin Dihydrochloride) in dosage form

N328403 October 24, 2022 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification; Country of Origin TARIFF NO.: 3004.90.9291 William Gerard Braier Radix Group International Dba DHL Global Forwarding 6120 Ace Industrial Drive Cudahy, WI 53110 RE: The tariff classification and country of origin of Javygtor (Sapropterin Dihydrochloride) in dosage form Dear Mr. Braier: In your letter dated September 27, 2022, on behalf of Dr. Reddy’s Laboratories, Inc., you requested a tariff classification and country of origin ruling. Javygtor (Sapropterin Dihydrochloride), imported in 100 mg tablets and 100 mg sachets, is the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Javygtor (Sapropterin Dihydrochloride) is a prescription medication indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). The applicable subheading for the Javygtor (Sapropterin Dihydrochloride) in dosage form will be 3004.90.9291, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other: Other: Other: Other.” The rate of duty will be free. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on the World Wide Web at https://hts.usitc.gov/current. 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. You also requested a country of origin determination. You stated that the active pharmaceutical ingredient (API), Sapropterin Dihydrochloride, is manufactured in Malta and that the finished tablets and sachets in dosage form are made in India. In India, the Sapropterin Dihydrochloride will be mixed with various inactive ingredients to produce the final tablets and sachets in dosage form. You suggest that the country of origin remains Malta, the country in which the API was manufactured. Section 134.1(b), Customs Regulations (19 CFR 134.1(b)), defines "country of origin" as: The country of manufacture, production or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the "country of origin" within the meaning of this part; …. A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact. See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and National Juice Products Association v. United States, 628 F. Supp. 978 (Ct. Int’l Trade 1986). In this case, we find the mixing of the active ingredient Sapropterin Dihydrochloride (made in Malta) with the inactive ingredients into the final dosage tablets and sachets in India does not result in a substantial transformation and the country of origin will be Malta. This ruling is being issued under the provisions of Part 177 of the Customs 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, contact National Import Specialist Judy Lee at judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division