N350471

N350471 July 18, 2025 OT:RR:NC:N3:138 CATEGORY: Origin Prakash Rajendran Viona Pharmaceuticals Inc 20 Commerce Drive, Suite 340 Cranford, NJ 07016 RE: The country of origin of Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% Dear Mr. Rajendran: In your letter dated June 20, 2025, you requested a country of origin ruling on Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%. Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% is a medicinal preparation containing Adapalene (topical retinoid) and Benzoyl Peroxide (antiseptic), as the active ingredients. It is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. In your letter, you stated Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% contains two active pharmaceutical ingredients (APIs). The Adapalene, USP is made in India and the Benzoyl Peroxide is made in Italy. In India these two APIs will be mixed with inactive ingredients to produce the final topical gel 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 determining whether a substantial transformation occurs in the manufacture of chemical products such as pharmaceuticals, CBP has consistently examined the complexity of the processing and whether the final article retains the essential identity and character of the raw material. To that end, CBP has generally held that the processing of pharmaceutical products from bulk form into measured doses does not result in a substantial transformation of the product. See, e.g., Headquarters Ruling (“HQ”) 561975, dated April 3, 2002; HQ 561544, dated May 1, 2000; HQ 735146, dated November 15, 1993; HQ H267177, dated November 5, 2016; HQ H233356, dated December 26, 2012; and, HQ 561975, dated April 3, 2002. However, where the processing from bulk form into measured doses involves the combination of two or more APIs, and the resulting combination offers additional medicinal benefits compared to taking each API alone, CBP has held that a substantial transformation occurred. See, e.g., HQ 563207, dated June 1, 2005. In this instance we note that the two APIs serve different purposes. Here, as in HQ 563207, two separate APIs are mixed to create a fixed combination drug that offers additional medicinal benefits compared to taking each API alone. Adapalene and Benzoyl Peroxide Gel works by killing the bacteria that cause acne and by keeping the skin pores clear. Adapalene is a topical retinoid that helps to regulate skin cell turnover and prevent the formation of comedones (clogged pores). It also has anti-inflammatory properties by reducing swelling and redness associated with acne. Benzoyl Peroxide works as an antiseptic to reduce the bacteria on the surface of the skin and helps remove dead skin cells by unclogging pores. In this case, we find the mixing of the active ingredients Adapalene (made in India) and Benzoyl Peroxide (made in Italy) with the inactive ingredients into the final topical gel in dosage form in India results in a substantial transformation and the country of origin will be India. 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). 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, (for) James Forkan Acting Director National Commodity Specialist Division

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,
 (for) James Forkan Acting Director National Commodity Specialist Division