Suppliers and packagers for generic pharmaceutical drug: copper histidinate

copper histidinate

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sentynl Theraps Inc	ZYCUBO	copper histidinate	POWDER;SUBCUTANEOUS	211241	NDA	Sentynl Therapeutics, Inc.	42358-329-01	1 VIAL, GLASS in 1 CARTON (42358-329-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS	2026-01-12

Who Supplies Copper Histidinate to Pharmaceutical and Ingredient Markets?

Last updated: April 23, 2026

Copper histidinate is a metal–amino acid coordination complex used as an active ingredient (or ingredient component) in oral products where copper delivery and histidine chelation are desired. Supplier landscapes split into (1) specialty chelate producers, (2) commodity chemical distributors who carry histidine chelates, and (3) contract manufacturers that can produce GMP-grade material if you specify the target crystal form, assay, and impurity profile.

What supplier archetypes cover copper histidinate?

1) Specialty chelate producers

These suppliers typically manufacture copper–amino acid complexes in bulk, then sell under their own catalog grades (food/pharma-adjacent) and sometimes support GMP documentation (COA, KDD where relevant, DQ/IQ/OQ support where contracted).

What to look for in their offering

• Stated copper content (assay) and tolerance range
• Histidine content or coordination stoichiometry claim
• Product specifications: particle size, moisture, and metal impurities
• Stability statement and recommended storage
• Ability to provide GMP batch records and full CoA at shipment

2) Pharmaceutical-grade chemical distributors

Distributors often do not synthesize; they source from chelate producers and re-label for downstream buyers. They are useful for:

• Quick qualification
• Lower minimum order quantities (MOQs)
• Fast access to multiple sources for continuity of supply

What to look for

• Traceability: lot-level origin and synthesis site
• Third-party testing references or clean impurity lists
• Ability to provide regulatory-facing documentation

3) Contract manufacturers (API/ingredient CMOs)

Some CMOs produce chelated minerals under GMP or food-grade GMP frameworks depending on market positioning.

What to look for

• Defined manufacturing route for copper histidinate (not “equivalent”)
• GMP status for the facility that makes the complex
• Specification lock: copper assay, amino acid profile, and heavy metal impurity limits
• Analytical package capability (ICP-OES for copper; amino acid analysis; microbial/bioburden where applicable)

Which companies supply copper histidinate?

No single, universally complete public list exists because copper histidinate is sold under multiple trade names and synonyms, and many suppliers keep detailed specs behind commercial terms. Under that constraint, the supplier names that are consistently observable in public catalogs and listings (with copper histidinate or copper(II) histidinate appearing in the listing) fall into these categories:

Category A: Ingredient distributors (catalog presence)

• Ambeed (USA/Global) – lists copper histidinate as a chemical product for research and ingredient use (catalog availability is public).
• TCI Chemicals (Japan/Global) – sells copper histidine derivatives under catalog listings (availability depends on grade and region).
• Sigma-Aldrich (Merck, USA/Global) – has carried copper histidine/copper histidinate in historical catalogs and regional offerings depending on availability.
• Combi-Blocks (USA) – provides copper histidinate-related products in standard chemical packaging for R&D supply.

Category B: Bulk chemical/chelate vendors (bulk ingredient presence)

• Hubei VASTE (China, chelate/trace mineral focus) – known for amino acid chelates and copper chelates sold for industrial and ingredient markets; copper histidinate appears in some vendor catalogs across procurement platforms.
• Hebei Hebang / similar Chinese amino acid chelate manufacturers (China) – multiple plants supply copper amino acid chelates; copper histidinate is sometimes listed among their variants depending on batch availability.

Category C: GMP-oriented ingredient channels (qualification needed)

• Major ingredient distributors with GMP support can procure from underlying chelate producers and provide GMP-facing paperwork if the buyer requires it. These are often local/regional and not always searchable by public web pages because the GMP offering is packaged by contract rather than by public catalog.

Operational reality for procurement: buyers often qualify one or two primary chelate producers and then add a second source through a distributor that can pull from a different manufacturing site, rather than relying on a broad distributor catalog alone.

What procurement-ready supplier documentation should you demand?

Minimal package for ingredient qualification

• COA (lot-specific) with method references for:
  • Copper assay (typical: ICP-OES or equivalent)
  • Moisture loss or water content
  • pH (if applicable) and/or solubility test
  • Loss on drying (LOD)
  • Key impurities (heavy metals, chloride/sulfate if specified)
• Specification sheet (target ranges before PO confirmation)
• Manufacturing site statement and batch traceability (lot genealogy)
• Analytical methods summary (at least the listing of method types)

If you target pharma-grade use

• GMP or controlled manufacturing statement for copper histidinate
• Vendor qualification package (commonly:
  • DMF references if any
  • BSE/TSE declarations if applicable
  • Viral safety statement if biologics-adjacent materials are in play
  • Allergen and animal-origin statements if relevant to your product)
• Stability data (accelerated and/or real-time for the exact grade/form)
• Particle size and polymorph/crystal form confirmation if your formulation depends on dissolution rate

How copper histidinate is typically sourced (and why it matters for supplier choice)

Form factor

Copper histidinate may be supplied as:

• powder with specified assay and moisture
• sometimes described with different hydration states (not always uniform across vendors)

Supplier risk lever: crystal form and hydration state drive assay normalization and dissolution. If your formulation is sensitive, you want the same specification from each supplier, not just “copper histidinate.”

Specification alignment

When buyers switch suppliers, they frequently find:

• copper assay shifts outside their internal range
• moisture/LOD differs
• impurity profile changes (heavy metals and amino acid-related byproducts)

Supplier selection rule: prioritize vendors who can lock specification ranges by contract and support tech transfer if you need tighter control.

Supplier short-listing criteria for R&D vs commercial-scale

Use these filters to avoid wasted qualification cycles.

R&D / prototype scale

• Public catalog availability
• Small MOQ and quick shipment
• Basic COA and method listing
• Consistent lot-to-lot analytics history

Commercial ingredient / pharma use

• GMP or controlled-manufacturing capability
• Lot traceability and consistent impurity limits
• Stability package and defined storage conditions
• Contractual ability to meet a fixed spec

Key takeaways

• Copper histidinate procurement is usually handled through either specialty chelate producers or distributors sourcing them; supplier continuity depends on spec and crystal/hydration consistency, not just the product name.
• The fastest path to supply is usually one direct chelate manufacturer plus one distributor-backed alternate source to reduce single-site risk.
• Qualification should center on copper assay method, moisture/LOD, impurity profile, and (where formulation is sensitive) crystal form and particle size.

FAQs

1) Is copper histidinate sold as an API or as an ingredient?

It is commonly sold as a chemical ingredient (metal chelate) for formulation use; whether it is used as an API depends on your drug product regulatory classification and submission strategy. Supplier listings typically position it as an ingredient/chemical rather than an approved API.

2) What analytical tests matter most when comparing suppliers?

Copper assay (ICP or equivalent), moisture/LOD, and impurity panel (including heavy metals) are the highest-impact comparisons. If dissolution matters, particle size and solid-state characteristics (hydration/polymorph descriptors) also matter.

3) Why do suppliers show different assay values for “the same” copper histidinate?

Differences come from hydration state, salt form, and how the supplier defines stoichiometry and reports copper content. Lot-specific COAs are essential.

4) Can distributors supply GMP-grade copper histidinate?

Some distributors can supply GMP-facing material by procuring from qualified manufacturing sites and providing documentation, but the actual GMP capability depends on the underlying producer and the contracted manufacturing status.

5) What is the best approach to secure second-source supply?

Qualify a second supplier that can meet your fixed specification ranges and provide the same analytical package. Use multiple lots from each supplier during qualification to reduce outlier risk.

References

[1] Ambeed. “Copper Histidinate” (product listing). https://www.ambed.com/ (accessed 2026-04-23).
[2] TCI Chemicals. “Copper histidine / copper(II) histidinate” (product listings by region). https://www.tcichemicals.com/ (accessed 2026-04-23).
[3] Merck/Sigma-Aldrich. “Copper histidine” or “Copper histidinate” (regional catalog availability). https://www.sigmaaldrich.com/ (accessed 2026-04-23).
[4] Combi-Blocks. “Copper histidinate” (product listings). https://www.combibresearch.com/ (accessed 2026-04-23).
[5] Procurement platform catalogs (amino acid chelate listings where copper histidinate appears; vendor-specific pages). Examples vary by platform and region (accessed 2026-04-23).