The tariff classification of Mycophenolate Motefil Injection, in dosage form, from India

N257284 September 29, 2014 CLA-2-30:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9115 Mr. Pradeep Shah Zydus Pharmaceuticals, USA Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Mycophenolate Motefil Injection, in dosage form, from India Dear Shah: In your letter dated September 12, 2014, you requested a tariff classification ruling. The subject, Mycophenolate Mofetil Injection, imported in 500 mg, is a medicinal preparation containing Mycophenolate Motefil Hydrochloride, an immunosuppressant as the active ingredient. It is indicated for the prevention of organ rejection in patients receiving renal, cardiac or hepatic transplants. In your ruling request, you were also seeking classification advice on Glipizide Extended Release Tablets, imported in 2.5 mg, 5 mg and 10 mg. The classification of this merchandise was previously addressed in NY Ruling N255003 which was issued to you on July 15, 2014. The applicable subheading for the Mycophenolate Mofetil Injection, imported in dosage form, will be 3004.90.9115, 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: Atineoplastic 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 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