OT:RR:NC:N3:138
Mr. Rajender Singh
Mankind Pharma Limited
208, Okhla Industrial Estate
New Delhi, 110020
India
RE: The country of origin of Baclofen Tablets USP
Dear Mr. Singh:
In your letter dated November 23, 2021, you requested a country of origin ruling determination on Baclofen Tablets.
Baclofen, imported in 5 mg, 10 mg and 20 mg tablets, is a muscle relaxant and antispastic medicament. It is indicated for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
You stated that the active pharmaceutical ingredient (API), Baclofen, is manufactured in Poland and that the finished tablets in dosage form are made in India. In India, Baclofen 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 Baclofen (made in Poland) with the inactive ingredients into the final dosage tablets in India does not result in a substantial transformation and the country of origin will be Poland.
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,
Steven A. Mack
Director
National Commodity Specialist Division