Are Research Peptides Made in the USA?

What are the stages between peptide starting material and a finished research material?

• Starting material origin: ICH Q7 describes an API starting material as a raw material, intermediate or active ingredient incorporated as a significant structural fragment, and states that it can be an article of commerce, a material obtained from one or more suppliers under contract or commercial agreement, or produced in-house.^[3]
• Synthesis: ICH Q7 covers active ingredients manufactured by chemical synthesis, among other processes. For peptides, solid-phase synthesis is the approach named in Merrifield's 1963 report, and a review by D'Hondt and colleagues groups the impurities that arise from it, such as amino acid deletions and insertions.^[3],[4],[5]
• Formulation: the active ingredient is combined with any other components into the finished form. 21 CFR 210.3 defines a drug product as the finished form that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients, and an FDA inspection guide lists the formulation of solutions as a distinct operation in making a lyophilized product.^[6],[7]
• Filling: in the process the FDA lyophilization inspection guide describes, the solution is filled into individual containers, which are partially stoppered and then transferred to the freeze-dryer.^[7]
• Lyophilization: the same guide describes lyophilization, or freeze drying, as a process in which water is removed from a product after it is frozen and placed under a vacuum, in three stages: freezing, primary drying and secondary drying.^[7]
• Packaging: ICH Q7 defines packaging material as material intended to protect the product during storage and transport, and states that container labels should indicate the name or identifying code and the batch number.^[3]
• Analytical testing: ICH Q6B groups the tests in a specification under identity, purity and impurities, potency and quantity, and ICH Q7 states that a certificate of analysis should list each test performed with its acceptance limits and numerical results.^[8],[3]
• Shipping: ICH Q7 states that material should be transported in a manner that does not adversely affect its quality, and that a system should be in place by which the distribution of each batch can be readily determined.^[3]

Why is country of origin more complicated than a single label?

Because the stages above can take place in different countries, the origin of the starting material and the location of later processing are separate facts. ICH Q7 notes that a starting material can be obtained from outside suppliers, so the place where synthesis occurs need not be the place where filling or lyophilization occurs.^[3]

The Federal Trade Commission's rule at 16 CFR Part 323 defines an unqualified U.S.-origin representation as any express or implied claim that a product, or a specified component of it, is of U.S. origin, including a claim that it is made, manufactured or produced in the United States.^[2]

Under section 323.2, labeling a product as made in the United States is an unfair or deceptive practice unless the final assembly or processing occurs in the United States, all significant processing occurs in the United States, and all or virtually all ingredients or components are made and sourced in the United States.^[2]

A statement that a named stage, such as filling or lyophilization, is performed at a location in the United States describes that stage only. It is narrower than a broad origin claim, which under the rule also depends on where significant processing occurs and where the ingredients were made and sourced.^[2]

What does "Made in USA" mean under the FTC standard?

The FTC's Made in USA Labeling Rule, codified in 2021 at 16 CFR Part 323, set the agency's "all or virtually all" standard for labels on products. FTC business guidance explains that the standard is met when the final assembly or processing and all significant processing take place in the United States and all or virtually all ingredients or components are made and sourced there, so that the product contains no, or negligible, foreign content.^[2],[9]

The same guidance states that a claim that a particular process was performed in the United States must be truthful, substantiated and clearly refer to that specific process rather than to the general manufacture of the product, and it cautions that general terms such as "produced" or "manufactured" are unlikely to convey a message limited to one process. The FTC describes the publication as its staff's view of the law's requirements.^[9]

The active ingredient in PepGenex research materials is synthesized outside the United States, so PepGenex makes no unqualified U.S.-origin claim for them. It names each stage and the place where that stage is performed instead, so that each statement refers to one process.

What does a certificate of analysis establish about origin?

It does not establish country of origin or manufacturing location. The tests ICH Q6B lists for a specification (identity, purity and impurities, potency and quantity) describe the material itself; none of them is a test of where the material was made.^[8]

ICH Q7 states that a certificate should show the name, address and telephone number of the original manufacturer, and that a re-issued certificate should show the laboratory that performed the analysis. An address on a certificate is information supplied by its issuer, not an analytical result, and the location of a testing laboratory is where the analysis was performed, not where the material was made.^[3]

A certificate's results apply to the batch it names. ICH Q7 defines a batch as a quantity expected to be homogeneous within specified limits, so a certificate for one lot says nothing about another lot.^[3]

Which stages does PepGenex document, and where do they occur?

PepGenex first-party information. Source: written confirmation from the laboratory that performs these stages, dated 2026-09-24.

• The active ingredient is synthesized outside the United States.
• Formulation is performed at a laboratory in Columbia, South Carolina.
• Filling is performed at a laboratory in Columbia, South Carolina.
• Lyophilization is performed at a laboratory in Columbia, South Carolina.
• Packaging is performed at a laboratory in Columbia, South Carolina.
• Shipping is performed at a laboratory in Columbia, South Carolina.
• Formulation, filling, lyophilization, packaging and shipping take place at the same facility.
• Analytical testing is performed by Accumark Labs, an independent laboratory in Anaheim, California.^[1]

What are the limitations of this page?

The stage locations above are first-party information from PepGenex, based on written confirmation from its processing laboratory dated 2026-09-24. They have not been independently audited.

This page does not claim that any PepGenex material is of U.S. origin. The active ingredient is synthesized outside the United States, and under 16 CFR 323.2 an unqualified U.S.-origin label depends on all or virtually all ingredients being made and sourced in the United States.^[2]

Who arranges the analytical testing of each lot is not documented in writing and is not stated here.

A certificate of analysis for a PepGenex lot reports test results. It does not establish where the material was made.

This page describes what the cited documents say. It is not a statement that any PepGenex material, or any other supplier's material, has been manufactured, tested or released under any of them.

Where can researchers access PepGenex research materials?

Research materials are available through Research Access.

References

1. Accumark Labs. Contact information published on the laboratory's website (Anaheim, California). accumarklabs.com
2. 16 CFR Part 323, Federal Trade Commission rule on U.S.-origin labeling, sections 323.1(a) and 323.2 (current edition). 16 CFR 323.1 · 16 CFR 323.2
3. ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. U.S. FDA guidance for industry, September 2016. FDA docket FDA-1995-D-0288
4. Merrifield RB. Solid Phase Peptide Synthesis. I. The Synthesis of a Tetrapeptide. J Am Chem Soc. 1963;85(14):2149-2154. DOI 10.1021/ja00897a025
5. D'Hondt M, Bracke N, Taevernier L, et al. Related impurities in peptide medicines. J Pharm Biomed Anal. 2014;101:2-30. PMID 25044089 · DOI 10.1016/j.jpba.2014.06.012
6. 21 CFR 210.3, Definitions, paragraph (b)(4) (current edition). 21 CFR 210.3(b)(4)
7. U.S. FDA. Guide to Inspections: Lyophilization of Parenteral (7/93). FDA Inspection Guide, July 1993
8. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. U.S. FDA guidance for industry, August 1999. FDA docket FDA-1998-D-0003
9. U.S. Federal Trade Commission. Complying with the Made in USA Standard. Business guidance publication, July 2024. ftc.gov business guidance