The country of origin of Clindamycin Phosphate Topical Lotion, 1% (ANDA 215607)

N344024 December 5, 2024 OT:RR:NC:N3:138 CATEGORY: Origin Kamesh Venugopal Encube Ethicals, Inc. 200 Meredith DriveDurham, NC 27713 RE:  The country of origin of Clindamycin Phosphate Topical Lotion, 1% (ANDA 215607) Dear Mr. Venugopal: In your letter dated November 14, 2024, you requested a country of origin ruling on Clindamycin Phosphate Topical Lotion, 1% on behalf of Encube Ethicals Private Limited. Clindamycin Phosphate Topical Lotion USP, 1%, imported in 60 mL bottles, is an antibiotic.  It is indicated for the treatment of acne vulgaris.You stated that the active pharmaceutical ingredient (API), Clindamycin Phosphate is manufactured in China, and that the finished lotion in dosage form is made in India.  In India, the Clindamycin Phosphate will be mixed with various inactive ingredients to produce the final Clindamycin Phosphate Topical Lotion 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, Clindamycin Phosphate (made in China) with inactive ingredients into the final dosage Clindamycin Phosphate Topical Lotion in India does not result in a substantial transformation and the country of origin will be China.You also submitted pictures of labels for our review. Based upon the labels provided, the subject product does not appear to be legally marked with the proper country of origin. The labels state the product is manufactured in India and distributed in the United States. However, the country of origin is China where the API is made and should be marked “Made in”,” Product of,” or other words of similar meaning with “China” as the country of origin. 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. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection 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, please contact National Import Specialist Judy Lee at judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division