OT:RR:NC:N:3:138
Mr. Kevin Knarr
Strides Pharma Inc.
2 Tower Center Blvd., Suite 1102
East Brunswick, NJ 08816
RE: The country of origin of Ranitidine Tablets imported in dosage form
Dear Mr. Knarr:
In your letter dated July 17, 2019, you requested a country of origin ruling determination on Ranitidine Tablets. Ranitidine Tablets is a medicinal preparation containing Ranitidine Hydrochloride, a histamine H2-receptor antagonist, as the active ingredient. It is indicated for the treatment and prevention of ulcers in the stomach and intestines. It is also used to treat Zollinger-Ellison syndrome, gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn. Ranitidine Tablets will be imported in 150 mg and 300 mg immediate release tablets.
You stated that the active pharmaceutical ingredient, Ranitidine Hydrochloride, is manufactured in India and the inactive ingredients will be sourced from various countries. In Singapore, the Ranitidine Hydrochloride will be mixed with the 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, Ranitidine Hydrochloride (India) with the inactive ingredients into the final dosage tablets in Singapore does not result in a substantial transformation and the country of origin will be India.
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