CLA-2-29:OT:RR:NC:N2:238

Mr. Pradeep Shah
Zydus Pharmaceuticals USA Inc.
210 Carnegie Center, Suite 103
Princeton, NJ 08540

RE: The tariff classification of Anastrozole Tablets, Donepezil Hydrochloride Tablets, Felodipine Tablets, Pramipexole Dihydrochloride Tablets and Finasteride Tablets in dosage form, from India

Dear Mr. Shah:

In your letter dated January 21, 2010, you requested a tariff classification ruling.

The first product, Anastrozole, imported in 1mg tablets, is a non-steroidal aromatase inhibitor. It is indicated for the treatment of breast cancer after surgery and for metastases in post-menopausal women.

The second product, Donepezil Hydrochloride, imported in 5mg and 10mg tablets, is a reversible inhibitor of the enzyme acetylcholinesterase. It is indicated for the treatment of mild to moderate dementia in patients with Alzheimer's disease.

The third product, Felodipine, imported in 2.5mg, 5mg and 10mg tablets, is a calcium channel blocker used as a vasodilator in the treatment of hypertension.

The fourth product, Pramipexole Dihydrochloride, imported in 0.125mg, 0.25mg, 0.75mg, 1mg and 1.5 mg tablets, is a dopamine agonist. It is indicated for the treatment of Parkinson's disease.

The last product, Finasteride, imported in 5mg tablets, is a synthetic antiandrogen. It is used for the treatment of benign prostatic hyperplasia (BPH) in low doses, and prostate cancer in higher doses. It is also used for the treatment of androgenetic alopecia (male-pattern baldness).

The applicable subheading for the Anastrozole tablets imported in dosage form will be 3004.90.9115, Harmonized Tariff Schedule of the United States (HTS), 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 or immunosuppressive medicaments.” The rate of duty will be free.

The applicable subheading for the Donepezil tablets imported in dosage form will be 3004.90.9140, 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: Other.” The rate of duty will be free.

The applicable subheading for Felodipine tablets imported in dosage form will be 3004.90.9120, 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: Cardiovascular medicaments.” The rate of duty will be free.

The applicable subheading for the Pramipexole Dihydrochloride tablets imported in dosage form will be 3004.90.9140, 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: Other.” The rate of duty will be free.

The applicable subheading for the Finasteride tablets imported 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 Harvey Kuperstein at (646) 733-3033.


Sincerely,

Robert B. Swierupski
Director
National Commodity Specialist Division