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Suppliers and packagers for generic pharmaceutical drug: THIOGUANINE
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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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: THIOGUANINE
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:
- API-specific GMP scope covering thioguanine
- Documented impurity profile control (identified impurities, limits, and method acceptance)
- Lot-to-lot consistency (CoA trends for assay and key impurities)
- 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
-
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. -
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. -
What quality attributes matter most for cytotoxic thioguanine?
Assay potency, key impurity identities and limits, and batch-to-batch reproducibility in CoAs. -
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. -
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.
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