Cognizin®
citicoline (CDP-choline)
CiticolineLast reviewed: July 11, 2026
Medical & Industry Advisor: Dr. James Pendleton, ND
Answer
Availability
We have not verified a current supply status for this ingredient. Unknown is our default: we publish a status only with dated evidence. If you have first-hand sourcing information, use the correction link below.
Owner and access
- Access model
- Licensed program
What it is
- Citicoline brand of Kyowa Hakko U.S.A., part of the Kyowa Hakko Bio / Kirin Holdings corporate family. [cognizin.com]
Spec parameters buyers should demand
What to ask for on the certificate of analysis and spec sheet. Identity, quality, and regulatory parameters only. This is not advice about efficacy.
| Parameter | What to ask | Why it matters |
|---|---|---|
| Assay (citicoline content) and form | Request the certificate of analysis, the assay method, and the exact form assayed. Citicoline is an official USP article published both as Citicoline and as Citicoline Sodium; ask which form the CoA reports so your label math uses the right basis.[USP Citicoline Sodium Reference Standard] | The free-base and sodium-salt forms differ in molecular weight, so the assay basis changes what a stated milligram figure represents. |
| Identity verification | Confirm the manufacturer runs at least one validated identity test on each incoming lot (for example infrared or HPLC), as 21 CFR 111.75(a)(1) requires for every dietary ingredient.[21 CFR 111.75(a)(1) — identity test required for each dietary ingredient] | Identity testing is a federal manufacturing requirement, and a certificate that names the identity method is the record your own quality file needs. |
| Provenance and licensed-brand verification | Ask the country and site of manufacture, and confirm the material is licensed Cognizin (Kyowa Hakko) rather than a generic citicoline substituted under the brand name.[cognizin.com] | A branded citicoline carries a specific manufacturing pedigree; provenance and licensed-use documentation confirm you are buying the material you are paying for. |
| Heavy metals | Request lead, arsenic, cadmium, and mercury results with the test method and the limits applied.[21 CFR Part 111 — cGMP for dietary supplements] | Heavy-metal control is a baseline quality attribute for any bulk ingredient and part of a complete certificate of analysis under 21 CFR Part 111. |
QC and testing considerations
- Every dietary ingredient must pass at least one validated identity test before use (21 CFR 111.75(a)(1)). Confirm your manufacturer runs identity testing on each incoming lot. [21 CFR 111.75(a)(1)]
- USP maintains compendial standards for both citicoline and citicoline sodium; the two forms are not interchangeable on a spec sheet, so confirm the CoA states which form was assayed and match it to your label declaration. [USP Citicoline Sodium Reference Standard]
- Ask for country of manufacture and licensed-brand documentation to distinguish branded Cognizin from generic citicoline sold under the same chemical name. [cognizin.com]
Further reading: How to read a certificate of analysis and third-party supplement testing.
Reference list
- USP Citicoline Sodium Reference Standard (compendial identity/assay standard, CAS 33818-15-4) Pharmacopeia
- 21 CFR Part 111 — Current Good Manufacturing Practice for dietary supplements (identity testing at 111.75) Regulatory
- Cognizin (Kyowa Hakko U.S.A.) — branded citicoline, owner site Owner technical
A reference list is not claim substantiation. Under the FTC's Health Products Compliance Guidance (December 2022), marketing claims about a finished product require competent and reliable scientific evidence, typically randomized, controlled human clinical testing. Responsibility for substantiating product claims rests with the brand.
Manufacturers with stated capability
No manufacturer has a listed capability for this ingredient yet. Listings are positive-only: an entry states a manufacturer can run the ingredient, never that one cannot.
Run this ingredient? Request inclusion.
Further reading
The decision framework behind this reference: five checkable criteria for choosing between a branded ingredient and its generic form.
What this page does not tell you
- Whether the owner will license your specific product or accept a new account.
- Pricing, minimum order volumes, or contract terms.
- Anything about efficacy. This is an identity and sourcing reference.
Prefills the ingredient into the RFQ Spec Builder. You enter your own formula; the tool formats it into a spec sheet.
Cognizin® is a registered trademark of Kyowa Hakko U.S.A., Inc. Inventory Ready is not affiliated with, licensed by, or endorsed by the trademark owner.
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