Suppliers and packagers for thioguanine

thioguanine

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Waylis Therap	THIOGUANINE	thioguanine	TABLET;ORAL	012429	NDA	Waylis Therapeutics LLC	80725-630-25	1 BOTTLE in 1 CARTON (80725-630-25) / 25 TABLET in 1 BOTTLE	2023-05-15

Suppliers and packagers for thioguanine

Last updated: April 23, 2026

Who Supplies Thioguanine (Active Pharmaceutical Ingredient) and Related Starting Materials?

Thioguanine is a cytotoxic thiopurine used in oncology. For procurement, the practical supply landscape splits into (1) API manufacturers (thioguanine itself) and (2) upstream thioguanine raw-material routes (thioguanine intermediates and nucleobase/thiopurine building blocks).

Which companies supply thioguanine API?

No complete, audit-grade supplier list can be produced from the information available in this chat. A compliant, “hard data” supplier table requires verifiable manufacturer-to-product linkages (for example: current catalog listings, marketing authorization database entries, or batch-release documentation tying a named supplier to “thioguanine” API). This level of sourcing is not present here.

What supplier tiers exist for thioguanine procurement?

A procurement program for thioguanine typically uses these supplier categories:

Supplier tier	What they sell	What matters for selection
API manufacturer	Thioguanine (API)	GMP status, DMF/CEP alignment, particle specs, CoA reproducibility
Contract manufacturers	API made under contract	tech transfer history, assay/impurity profile control
Specialty chemical suppliers	Thioguanine intermediates/building blocks	route consistency, impurity qualification, traceability
Distributors	API sourced from upstream manufacturers	lead times, MOQ, documentation completeness (CoA, SDS)

Thioguanine Supply Inputs: What upstream materials are typically sourced?

Thioguanine is a thiopurine nucleobase. Supply due diligence typically extends to upstream inputs such as:

• Thiopurine nucleobase precursors used to build the thioguanine ring system
• Sulfur-introduction reagents used in thiopurine routes
• Purification reagents used to meet thioguanine impurity specifications

No specific named upstream suppliers can be listed without product-linked sourcing evidence.

What proof points a thioguanine sourcing bid should require

Use the same documentation package that regulatory and quality teams expect for cytotoxic APIs:

Proof point	Minimum expectation in bids
GMP statement	Facility manufacture under GMP for API (or equivalent)
Quality documents	CoA for each lot, SDS, impurity report
Compliance file	DMF or CEP reference where applicable, or supplier qualification file
Analytical methods	Assay and impurities methods or cross-reference
Traceability	Batch genealogy and material traceability through receipt-to-use

Market and regulatory context that affects who supplies

Thioguanine is a controlled cytotoxic category in many markets. Supplier availability is shaped by:

• Oncology-focused GMP capacity
• Availability of qualified impurity profiles
• Export documentation for cytotoxic substances
• Regulatory listing status tied to specific jurisdictions

Operational sourcing checklist (actionable for procurement)

A thioguanine supplier shortlist should be built using a repeatable filter:

1. API-specific GMP scope covering thioguanine
2. Documented impurity profile control (identified impurities, limits, and method acceptance)
3. Lot-to-lot consistency (CoA trends for assay and key impurities)
4. Supply continuity (back-up lots, alternate manufacturing sites if offered)

Key Takeaways

• Thioguanine procurement requires API-specific GMP and documentation; distributor-only sourcing without a qualified manufacturer link increases qualification risk.
• A named supplier list cannot be produced from this chat without verifiable evidence tying specific companies to thioguanine API supply.
• Build bids around GMP scope, CoA/impurities, compliance file linkage, and traceability rather than catalog claims.

FAQs

1. Is thioguanine typically sourced from the same companies that supply other thiopurines?
   API supply is often adjacent across thiopurines, but thioguanine production requires product-specific GMP and impurity qualification, so the overlap is not guaranteed.

2. Do distributors count as suppliers for qualification purposes?
   Distributors can provide product, but qualification usually requires identification and approval of the underlying API manufacturer and documentation traceability.

3. What quality attributes matter most for cytotoxic thioguanine?
   Assay potency, key impurity identities and limits, and batch-to-batch reproducibility in CoAs.

4. How do regulatory files affect thioguanine sourcing?
   Where a DMF/CEP exists for thioguanine, it can speed qualification; if not, suppliers may require deeper technical and quality assessment.

5. What documentation is non-negotiable for thioguanine API?
   Lot CoA, SDS, impurity data, and facility/GMP scope statements that directly cover thioguanine.

---

References

[1] European Medicines Agency (EMA). European public assessment reports and related regulatory documentation for thioguanine-containing products.
[2] U.S. FDA. Drug master file (DMF) overview and regulatory guidance for API submissions.
[3] WHO. Good manufacturing practices and GMP expectations for pharmaceutical substances.