CLA-2-30:OT:RR:NC:N3:138
Mr. Steve Johnsen
Bayer International Trade Services Corporation
651 Colliers Way, Suite 414
Weirton, WV 26062
RE: The tariff classification of Finerenone (CAS No. 1050477-31-0) in bulk form and Kerendia® Tablets in dosage form, from Germany
Dear Mr. Johnsen:
In your letter dated September 2, 2021, you requested a tariff classification ruling.
Finerenone is a nonsteroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the progression of chronic kidney disease, risk of kidney failure and risk of cardiovascular disease in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes.
Kerendia®, imported in 10 mg and 20 mg tablets, is the brand-named drug containing Finerenone, as the active ingredient. It is indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
In your letter, you suggested classification of Finerenone in subheading 2937.29.9095, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Hormones, prostaglandins, thromboxanes and leukotrienes, natural or reproduced by synthesis; derivatives and structural analogues thereof, including chain modified polypeptides, used primarily as hormones: Steroidal hormones, their derivatives and structural analogues: Other: Other: Other.” You also suggested classification of Kerendia® tablets in subheading 3004.39.0050, 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, containing hormones or other products of heading 2937: Other: Other.” Pursuant to Explanatory Note 29.37(V)(b), Finerenone does not meet the terms of heading 2937. Therefore, Finerenone and Kerendia® tablets are classified in the tariff provisions below.
The applicable subheading for the Finerenone in bulk form will be 2933.99.7500, HTSUS, which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Other: Other: Aromatic or modified aromatic: Other: Drugs: Other.” The rate of duty will be 6.5 percent ad valorem. Currently, Finerenone is not listed in the Pharmaceutical Appendix to the Tariff Schedule.
The applicable subheading for the Kerendia® Tablets in dosage form will be 3004.90.9290, 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.
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 [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division