Suppliers and packagers for generic pharmaceutical drug: AURANOFIN

AURANOFIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Legacy Pharma	RIDAURA	auranofin	CAPSULE;ORAL	018689	NDA	Sebela Pharmaceuticals Inc.	54766-093-06	60 CAPSULE in 1 BOTTLE (54766-093-06)	2016-12-15
Legacy Pharma	RIDAURA	auranofin	CAPSULE;ORAL	018689	NDA AUTHORIZED GENERIC	Coral Way Pharma, LLC	85437-093-06	60 CAPSULE in 1 BOTTLE (85437-093-06)	2025-10-29

Suppliers and packagers for generic pharmaceutical drug: AURANOFIN

Last updated: April 25, 2026

Who Supplies Auranofin to the Pharmaceutical Industry?

Auranofin is a small-molecule gold-based API (chemical formula C20H12AuF5N5O). Commercial supply is typically handled through (1) API specialists selling finished auranofin as a catalog chemical and (2) CDMOs sourcing gold-organic intermediates and finishing API to GMP for branded generics and research use. Below is a supplier map focused on companies that have an observable commercial footprint for auranofin (catalog availability, chemical distribution, or documented pharma supply activity).

Which suppliers are commonly associated with auranofin availability?

Catalog chemical suppliers and distributors (API or research-grade)

These firms frequently list auranofin for sale as a chemical product. They are the fastest channel for early screening and process feasibility work.

Supplier	Typical positioning	What to verify for pharma use
TCI Chemicals	Catalog chemical	GMP statement, specification sheet, CoA availability
Selleck Chemicals	Catalog chemicals and research reagents	Purity grade, analytical package (HPLC/LC-MS), regulatory documentation
MedChemExpress (MCE)	Catalog chemicals and research reagents	Batch CoA, impurities profile, traceability
Cayman Chemical	Reference standards and life science chemicals	Whether they supply GMP-grade and stability documentation
Sigma-Aldrich / Merck (where listed)	Broad chemical distributor	Grade (research vs GMP), documentation format

API-focused and chemical-manufacturing suppliers (potential GMP sourcing)

These firms are more likely to offer auranofin under a regulated supply model, often with GMP documentation for downstream development.

Supplier	Typical positioning	What to verify for GMP supply
Amadis Chemical	Custom synthesis and chemical manufacturing	GMP capability for auranofin or closely controlled gold-organic chemistry routes
Alfa Aesar (Thermo Fisher Scientific)	Technical chemical supply	Grade status, regulatory readiness for API
Apollo Scientific	Lab chemical supplier	Supply grade, CoA, and traceability commitments

How to shortlist the right auranofin supplier for drug development

Most buyer failures come from mixing catalog-grade material with pharma-grade expectations. The shortlist criteria that matter are documentation, process control, and analytical coverage.

Minimum supply dossier items to require

• Batch CoA with at least one stability-relevant assay method (commonly HPLC)
• Identification (IR and/or NMR and/or LC-MS)
• Impurity panel (at minimum total impurities plus named/identified major impurities when available)
• Particle size and water content (Karl Fischer) if your formulation is sensitive
• Gold content confirmation when relevant to spec (auranofin is a gold complex)
• Residual solvents statement (ICH Q3C) when manufacturing uses solvent-intensive routes
• Regulatory status letter (GMP, DMF support if applicable, or comparable quality agreement)

Supply strategy by intended use

Different use cases change supplier priority.

Discovery and mechanistic screening

Prioritize:

• Fast lead time catalog suppliers with high purity
• Suppliers that provide LC-MS or detailed impurity analytics

Preclinical tox and process optimization

Prioritize:

• Suppliers that can provide consistent batch-to-batch CoAs
• Suppliers offering material that meets your internal impurity acceptance criteria

Clinical supply and commercial programs

Prioritize:

• GMP API suppliers or CDMOs that can demonstrate:
  • Controlled gold-organic synthesis steps
  • Validated analytical methods
  • Change control and stability data

What to look for in auranofin quality specs

Auranofin quality is dominated by assay, impurities, and the integrity of the gold complex. Buyers should ensure the supplier’s specs match the intended regulatory pathway.

Core spec categories to request (typical API framework):

• Assay (purity)
• Impurities
• Water content
• Residual solvents
• Heavy metals (if applicable beyond gold confirmation)
• Microbial limits (often not required for APIs depending on route and spec, but confirm with your quality plan)

Commercial context that affects supplier availability

Auranofin’s supply footprint depends on whether the supplier can handle gold-complex chemistry consistently and provide GMP documentation. Gold-organic APIs often concentrate in fewer plants than commodity organics, so supplier continuity matters more than price during scale-up.

Supplier selection checklist (actionable)

Use this as a gate before you lock samples or pricing.

1. Documentation: batch CoA + complete spec sheet, not a partial SDS package.
2. Analytical coverage: assay method, identification method, impurity method(s).
3. Consistency: at least 2 consecutive lot CoAs with narrow ranges.
4. Traceability: manufacturer of record and site-level information.
5. Change control: written policy for notifying you of route, site, or method changes.
6. Regulatory readiness: ability to support your QA with GMP statements.

Key Takeaways

• Auranofin is supplied through catalog chemical channels (TCI, Selleck, MCE, Cayman, and others) and through more regulated API supply channels where GMP documentation is available via API manufacturers and qualified chemical producers.
• For drug development, supplier value is defined by batch CoA completeness, impurity analytics, and GMP-quality documentation, not only by stated purity on a website.
• Shortlist suppliers that provide repeatable CoAs across multiple lots and can support residual solvents, water content, and impurity panels consistent with API expectations.

---

FAQs

1) Is auranofin sold as an API or mostly as a research chemical?

It is widely sold as a chemical through research reagent channels, but a subset of suppliers can support regulated API-style documentation. The determining factor is whether the supplier provides GMP-grade specifications and complete batch CoAs.

2) Which supplier type is best for clinical-grade auranofin?

Choose a supplier that can provide GMP API documentation (CoA, full spec sheet, controlled manufacturing record traceability). Catalog-only listings typically do not meet clinical expectations.

3) What quality attributes matter most for auranofin?

Assay (purity), impurity profile, water content, residual solvents, and confirmation that the gold complex is intact (via identification and impurity analytics).

4) Do gold-complex APIs have fewer suppliers?

Yes. Gold-organic chemistry concentrates manufacturing capability in fewer facilities that can control the synthesis and purification steps and still provide consistent analytical results.

5) What should a buyer request before placing an order?

A complete CoA for the exact batch, the full spec sheet, and analytical methods supporting identification, assay, and impurities, plus documentation of residual solvents and water content where relevant.

---

References

[1] TCI Chemicals. “Auranofin” product page (catalog listing and technical documentation).
[2] Selleck Chemicals. “Auranofin” product page (catalog listing and specifications).
[3] MedChemExpress (MCE). “Auranofin” product page (catalog listing and specifications).
[4] Cayman Chemical. “Auranofin” product page (reference standard and technical documentation).
[5] Merck/Sigma-Aldrich. “Auranofin” product listing (where available by market).
[6] Thermo Fisher Scientific (Alfa Aesar). “Auranofin” listing (technical and grade information).
[7] Apollo Scientific. “Auranofin” listing (product and documentation details).
[8] Amadis Chemical. Auranofin related manufacturing or custom synthesis capability pages (where listed).