CLA-2-29:OT:RR:NC:N3:138
Kenn Leifheit
Flavine North America, Inc.
61 South Paramus Road, Suite 565
Paramus, NJ 07652
RE: The tariff classification of Vilanterol Trifenatate (CAS No. 503070-58-4) in bulk powder form and
Umeclidinium Bromide (CAS No. 869113-09-7) in bulk powder form, from India
Dear Mr. Leifheit:
In your letter dated April 4, 2025, you requested a tariff classification ruling.
Vilanterol Trifenatate is a selective long-acting 2-adrenergic agonist (LABA). It is used in combination with
other bronchodilators for the management of chronic obstructive pulmonary disease (COPD), including
chronic bronchitis and/or emphysema.
Umeclidinium Bromide is a long-acting muscarinic antagonist (LAMA) used as a maintenance treatment for
symptoms of chronic obstructive pulmonary disease (COPD).
The applicable subheading for the Vilanterol Trifenatate in bulk powder form will be 2922.50.2500,
Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Oxygen-function
amino-compounds: Amino-alcohol-phenols, amino-acid-phenols and other amino-compounds with oxygen
function: Aromatic: Other: Drugs: Other: Other.” Pursuant to GN 13, HTSUS, the rate of duty will be free.
Vilanterol Trifenatate is listed in Table 3 of the Pharmaceutical Appendix to the Tariff Schedule.
The applicable subheading for the Umeclidinium Bromide in bulk form will be 2933.39.4100, HTSUS,
which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an
unfused pyridine ring (whether or not hydrogenated) in the structure: Other: Other: Drugs: Other.” The rate
of duty will be 6.5 percent ad valorem. Currently, Umeclidinium Bromide is not listed in the Pharmaceutical
Appendix to the Tariff Schedule.
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/.
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 [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division