CLA-2-30:OT:RR:NC:N3:138
William Braier
Radix Group International
dba DHL Global Forwarding
6120 Ace Industrial Drive Cudahy, WI 53110
RE: The tariff classification and country of origin of Sunitinib Malate Capsules in dosage form
Dear Mr. Braier:
In your letter dated January 4, 2023, on behalf of Dr. Reddy’s Laboratories, Inc., you requested a tariff classification and country of origin determination ruling.
Sunitinib Malate, imported in 12.5 mg, 25 mg, 37.5 mg and 50 mg capsules, is a receptor tyrosine kinase inhibitor. It is indicated for the treatment of renal cell carcinoma (RCC) and imatinib resistant gastrointestinal stromal tumor (GIST).
The applicable subheading for the Sunitinib Malate Capsules in dosage form will be 3004.90.9215, 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: Antineoplastic and immunosuppressive medicaments.” 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 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) Sunitinib Malate, is manufactured in Malta and that the finished capsules in dosage form are made in India. In India, Sunitinib Malate will be mixed with various inactive ingredients to produce the final capsules 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 Sunitinib Malate (made in Malta) with the inactive ingredients into the final dosage capsule 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, please contact National Import Specialist Judy Lee at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division