The tariff classification of Amlodipine Step 3 Intermediate Compound (CAS# 88150-62-3, formerly CAS# 103094-30-0) in bulk form, from Italy

N019387 January 11, 2008 CLA-2-29:OT:RR:NC:2:238 CATEGORY: Classification TARIFF NO.: 2933.39.4100 Mr. Patrick D. Gill Rode & Qualey 55 West 39th Street New York, NY 10018 RE: The tariff classification of Amlodipine Step 3 Intermediate Compound (CAS# 88150-62-3, formerly CAS# 103094-30-0) in bulk form, from Italy Dear Mr. Gill: In your letter dated November 1, 2007, on behalf of your client, Pfizer Inc., you requested a tariff classification ruling. You also inquired about the applicability of General Note 13 of the Harmonized Tariff Schedule of the United States (HTSUS). In your submission, you suggested classification of Amlodipine Step 3 in subheading 2933.39.4100, as a drug. We concur. Amlodipine Step 3, also known as “phthalimido Amlodipine,” is the critical intermediate in the manufacture of Amlodipine (INN) (CAS# 88150-42-9), an anti-anginal, antihypertensive drug. Based on a review of patent information, Amlodipine Step 3 contains the moiety essential to the efficacy of Amlodipine. To address your concern regarding the applicability of General Note 13, HTSUS, we had the New York Customs Laboratory perform a Chemical Abstracts Service (CAS®) Data Base inquiry. Amlodipine Step 3 has the CAS name 3,5-Pyridinedicarboxylic acid, 4-(2-chlorophenyl)-2-[[2-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)ethoxy]methyl]-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester. This name has the assigned CAS Number 88150-62-3. This is not a number included in the Pharmaceutical Appendix to the Harmonized Tariff Schedule. However, our Data Base inquiry supports your contention that this CAS Number replaced CAS# 103094-30-0, which is included in Table 3 of the Pharmaceutical. To further complicate matters, the chemical name provided in the Pharmaceutical Appendix for CAS# 103094-30-0 is erroneously provided as: 3-Ethyl 5-methyl (?)-4-(2-chlorophenyl)-1,4-dihydro-2-[2-(1,3-dioxoisoindolin-2-yl)ethoxymethyl]pyridine-3,5-dicarboxylate. The 6-methyl contained in the Amlodipine Step 3 molecule was left out of this name. This chemical name is represented by CAS# 928715-96-2. A CAPlus query found no applications for this chemical. It is the opinion of this office that the intent was to include Amlodipine Step 3 in Table 3 of the Pharmaceutical Appendix, despite the use of an incorrect name and a deleted CAS Number. We would emphasize that the CAS Number is not an invalid number, but, rather, a deleted number, replaced by another number. Such situations are not uncommon in the registry process. At the time of inclusion in Table 3 CAS# 103094-30-0 was assigned to Amlodipine Step 3. To avoid difficulties in the future, we strongly recommend that you bring the present situation to the attention of the Secretary, United States International Trade Commission, 500 E Street, SW., Washington, DC 20436. The applicable subheading for the Amlodipine Step 3 intermediate will be 2933.39.4100, HTSUS, which provides for "Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure: Other: Other: Drugs: Other." Pursuant to General Note 13, HTS, 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