CLA-2-29:OT:RR:NC:N3:138
Trupti Ranjan Behera
MSN Laboratories Private Limited
Sy No. 10 & 11, Whitefields, Hitech City Hyderabad 500081 India
RE: The tariff classification of Letermovir (CAS No. 917389-32-3) in bulk form, from India
Dear Ms. Behera:
In your letter dated December 11, 2024, you requested a tariff classification ruling.
Letermovir is an antiviral drug indicated for the treatment of cytomegalovirus (CMV) infections. In your letter, you stated Letermovir will be used for medicinal development purposes and will be imported in 100 grams packed in a high density polyethylene (HDPE) container.
The applicable subheading for the Letermovir in bulk form will be 2933.59.3600, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing a pyrimidine ring (whether or not hydrogenated) or piperazine ring in the structure: Other: Drugs: Aromatic or modified aromatic: Anti-infective agents: Other.” The rate of duty will be 6.5 percent ad valorem. Currently, Letermovir 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