CLA-2-30:OT:RR:NC:N3:138

Mr. Pradeep Shah
Zydus Pharmaceuticals USA Inc.
73 Route 31 North
Pennington, NJ 08534

RE: The tariff classification of Lacosamide Injection and Bortezomib Injection in dosage form, from India

Dear Mr. Shah:

In your letter dated January 19, 2022, you requested a tariff classification ruling.

Lacosamide Injection, imported in 10 mg/mL, is an anticonvulsant indicated for the treatment of partial-onset seizures in patients 4 years of age and older. It is also indicated for use as an adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.

Bortezomib Injection, imported in 3.5 mg/10 mL, is a proteasome inhibitor. It is indicated for the treatment of adult patients with multiple myeloma and treatment of adult patients with mantle cell lymphoma.

The applicable subheading for the Lacosamide Injection in dosage form will be 3004.90.9230, 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: Medicaments primarily affecting the central nervous system: Anticonvulsants, hypnotics and sedatives.” The rate of duty will be free.

The applicable subheading for the Bortezomib Injection in dosage form will be 3004.90.9215, 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 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