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NY 815340




October 16, 1995

CLA-2-30:R:N2:238 815340

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.90.9040

Mr. Italo Mazzitti
Fidia Pharmaceutical Corporation
1401 Eye Street, N.W. - Suite 900
Washington, D.C. 20005

RE: The tariff classification of Sygen , imported in formulations put up in 50mg/2ml glass ampoules or 100mg/2ml glass ampoules, from Italy

Dear Mr. Mazzitti:

In your letter dated August 31, 1995, received by this office on September 29, 1995, you requested a tariff classification ruling.

The subject products consist of formulations put up in glass ampoules (50 mg/2ml ampoules or 100mg/2ml ampoules) containing Sygen , chemically known as monosialotetrahexosylganglioside GM1 sodium salt, as the active ingredient. You indicate in your letter that Sygen is currently undergoing clinical trials in the United States and Canada for its ability to regenerate and/or stimulate the growth of nervous tissue in cases of acute spinal cord injury and Parkinson's disease.

The applicable subheading for the subject products will be 3004.90.9040, 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: Medicaments primarily affecting the central nervous system: Other." The rate of duty will be free.

This merchandise may be subject to the regulations of the Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number (301) 443-6553.

This ruling is being issued under the provisions of Section 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 C. Reilly at 212-466-5770.

Sincerely,

Roger J. Silvestri

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