CLA-2-29:OT:RR:NC:N3:138
Yaling Lo
Pharmaports LLC
1 E Uwchlan Ave., Suite 116
Exton, PA 19341
RE: The tariff classification of Biolimus (CAS No. 851536-75-9) in bulk form, from Taiwan
Dear Ms. Lo:
In your letter dated November 3, 2025, on behalf of Chunghwa Chemical Synthesis & Biotech Co. Ltd., you
requested a tariff classification ruling.
Biolimus is a derivative of Sirolimus, and an inhibitor of mTOR (Mammalian target of rapamycin). It is an
immunosuppressant drug and it is also known as Umirolimus (INN). In your letter, you stated that Biolimus
is an anti-proliferative drug used in drug-eluting coronary stents to prevent restenosis.
The applicable subheading for the Biolimus in bulk form will be 2941.90.5000, Harmonized Tariff Schedule
of the United States (HTSUS), which provides for “Antibiotics: Other: Other: Other.” The general rate of
duty will be free.
Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must
be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the
Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time, products of Taiwan will be
subject to an additional ad valorem rate of duty of 20 percent. However, your product falls within an
excepted subheading. At the time of entry, you must report the Chapter 99 heading applicable to your product
classification, i.e. 9903.01.32, in addition to subheading 2941.90.5000, HTSUS, listed above.
The tariffs and additional duties cited above are current as of this ruling’s issuance. 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,
(for)
Deborah Marinucci
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division