CLA-2-30:OT:RR:NC:2:238
Mr. Pradeep Shah
Zydus Pharmaceuticals (USA) Inc.
73 Route 31 North,
Pennington, NJ 08534
RE: The tariff classification of Dutasteride Soft Gelatin Capsules in dosage form, from India
Dear Mr. Shah:
In your letter dated July 27, 2015, you requested a tariff classification ruling.
The subject product, Dutasteride Soft Gelatin Capsules in 0.5 mg, is a synthetic steroid analogue. It is indicated for the treatment of benign prostatic hyperplasia in men with an enlarged prostate.
The applicable subheading for the Dutasteride Soft Gelatin Capsules in dosage form, will be 3004.39.0050, 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Containing hormones or other products of heading 2937 but not containing antibiotics: 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 World Wide Web at http://www.usitc.gov/tata/hts/.
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,
Gwenn Klein Kirschner
Director
National Commodity Specialist Division