The country of origin of Acetazolamide Tablets in dosage form

N313455 August 21, 2020 OT:RR:NC:N3:138 CATEGORY: Country of Origin Mr. Rajender Singh Mankind Pharma Limited 208, Okhla Industrial Estate, New Delhi, 110020 India RE: The country of origin of Acetazolamide Tablets in dosage form Dear Mr. Singh: In your letter dated July 24, 2020, you requested a country of origin ruling determination on Acetazolamide Tablets.Acetazolamide, imported in 125 mg and 250 mg tablets, is a carbonic anhydrase inhibitor. It is indicated for the adjunctive treatment of edema due to congestive heart failure, drug-induced edema, centrencephalic epilepsies (petit mal, unlocalized seizures), chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. It is also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent. You requested a country of origin determination. You stated that the active pharmaceutical ingredient (API), Acetazolamide, is manufactured in Poland and that the finished tablets in dosage form are made in India. In India, the Acetazolamide 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 Acetazolamide (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 judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division