The country of origin of Buspirone Hydrochloride Tablets in dosage form, from Germany

N303420 April 12, 2019 OT:RR:NC:N3:138 CATEGORY: Country of Origin Mr. Kevin J. Knarr Strides Pharma Inc. 2 Tower Center Blvd, Suite 1102 East Brunswick, NJ 08816 RE: The country of origin of Buspirone Hydrochloride Tablets in dosage form, from Germany Dear Mr. Knarr: In your letter dated March 13, 2019, you requested a country of origin ruling. A sample was not provided with your letter. Buspirone Hydrochloride, imported in 5 mg, 7.5 mg, 10 mg, 15 mg, and 30 mg tablets, is a medicinal preparation containing Buspirone Hydrochloride, an anxiolytic psychoactive drug, as an active ingredient. It is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. In your letter, you stated Strides Pharma sources the active pharmaceutical ingredient (API) Buspirone Hydrochloride from a company that manufactures the API in Germany. This API (Buspirone Hydrochloride) is then shipped to India. In India, Buspirone Hydrochloride will be mixed with various inactive ingredients to produce the final tablets in dosage form. Section 134.1(b), Customs Regulations (19 CFR 134.1(b)), defines "country of origin" as: the country of manufacture, production or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the "country of origin" within the meaning of this part;…. A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact. See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and National Juice Products Association v. United States, 628 F. Supp. 978 (Ct. Int’l Trade 1986). In this case, we find the mixing of the active ingredient Buspirone Hydrochloride (German origin) with the inactive ingredients into the final tablets in dosage form in India does not result in a substantial transformation and the country of origin will be Germany. 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, Steven A. Mack Director National Commodity Specialist Division