CLA-2:OT:RR:NC:N3:138
Ankit Patel
Granules Pharmaceuticals Inc.
3701 Concorde Parkway
Chantilly, VA 20151
RE: The country of origin of Ibuprofen Tablets, USP in dosage form
Dear Mr. Patel:
In your letter dated November 19, 2025, you requested a country of origin ruling on Ibuprofen Tablets.
Ibuprofen, imported in 400 mg, 600 mg and 800 mg tablets, is a medicinal preparation containing Ibuprofen,
a nonsteroidal anti-inflammatory drug (NSAID), as the active ingredient. It is indicated for the relief of the
signs and symptoms of rheumatoid arthritis and osteoarthritis, for the relief of mild to moderate pain, and for
the treatment of primary dysmenorrhea.
You stated that the active pharmaceutical ingredient (API), Ibuprofen, is manufactured in China. In China,
the Ibuprofen is mixed with other inactive ingredients to produce Ibuprofen granules DC 85% (“Premix
API”). The manufacturing steps include mixing, drying, milling, blending and packaging into a suitable bulk
packaging configuration and then shipped to the United States for further processing into the finished dosage
tablets. In the United States, the premix API is directly compressed and coated to produce the finished
product, Ibuprofen Tablets USP 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 this case, we find the processing of the Premix API (made in China) into the final tablets in dosage form in
the United States does not result in a substantial transformation and the country of origin is China, where the
API is made.
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)
Evan Conceicao
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division