OT:RR:NC:N3:138
Prakash Rajendran
Viona Pharmaceuticals Inc.
20 Commerce Drive, Suite 340
Cranford, NJ 07016
RE: The country of origin of Amlodipine and Atorvastatin Tablets USP, in dosage form
Dear Mr. Rajendran:
In your letter dated July 15, 2026, you requested a country of origin ruling on Amlodipine and Atorvastatin
Tablets in dosage form.
Amlodipine and Atorvastatin Tablets imported in various dosages consist of a combination of Amlodipine
Besylate (calcium channel blocker) and Atorvastatin Calcium (HMG-CoA reductase inhibitor), as the active
ingredients. It is indicated for the treatment of high blood pressure and high cholesterol.
You stated that the active pharmaceutical ingredients (APIs), Amlodipine Besylate and Atorvastatin Calcium
are manufactured in India. In India, these two APIs will be mixed with various inactive ingredients to
produce the final Amlodipine and Atorvastatin Tablets in dosage form.
When determining the country of origin, the substantial transformation analysis is applicable. See, e.g.,
Headquarters Ruling Letter (“HQ”) H301619, dated November 6, 2018. The test for determining whether a
substantial transformation will occur is whether an article emerges from a process with a new name,
character, or use different from that possessed by the article prior to processing. See Texas Instruments Inc. v.
United States, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See
National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993).
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., 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 case, we note that the two separate APIs are mixed to create a combination drug that offers additional
medicinal benefits compared to taking each API alone. Both APIs (Amlodipine Besylate and Atorvastatin
Calcium) are made in India and the mixing of the APIs with the inactive ingredients into the final dosage
tablets also occurs in India. Therefore, we find the country of origin of the Amlodipine and Atorvastatin
Tablets is 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.
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 [email protected].
Sincerely,
(for)
James P. Forkan
Director
National Commodity Specialist Division