Last updated: April 24, 2026
Azulfidine (Sulfasalazine): Who Supplies the Active and Key Inputs?
Azulfidine is the brand name for sulfasalazine (an oral 5-ASA prodrug used in ulcerative colitis and rheumatoid arthritis). Sourcing decisions hinge on two layers: active pharmaceutical ingredient (API) supply and key excipient and packaging input chains for finished-dose tablets/suspensions.
What are the known API suppliers for azulfidine (sulfasalazine)?
No complete, reliable supplier roster can be produced from the information available in this chat. A correct “who supplies the drug” answer requires manufacturer/holder-to-supplier mapping from verifiable sources (regulatory listings such as FDA’s Orange Book labeling/manufacturer tables, EMA product dossiers, or supplier disclosures in DMFs), which is not present here.
What are the key input categories suppliers typically cover for azulfidine tablets?
Below is the supplier landscape that commonly matters for sulfasalazine finished-dose manufacture in markets where tablets dominate.
1) API suppliers
- Sulfasalazine API manufacturers (often via DMFs or direct commercial supply)
- API re-packers and distributors (where the tablet holder sources API through trading houses)
2) Excipients (tablet formulation supply)
- Binders (common: povidone, HPMC)
- Disintegrants (common: croscarmellose sodium, sodium starch glycolate)
- Lubricants (common: magnesium stearate)
- Glidants (common: colloidal silicon dioxide)
- Film-coating materials, when used (for coated tablets)
3) Packaging suppliers
- Bottles and caps (HDPE with child-resistant caps or similar)
- Blister pack materials (PVC/PVDC and aluminum foil)
- Desiccants and induction seals (where specified)
- Label stock and carton materials
4) Quality and regulatory support
- GMP testing labs (release and stability testing)
- Analytical method validation vendors
- Stability chamber and packaging qualification providers
How do dosing forms affect supplier selection for azulfidine?
Most supply-chain differences come from whether a market uses:
- Immediate-release tablets (typical for sulfasalazine brand/formulations), which mainly changes excipient set and compression tooling qualification
- Any alternative presentations (less common), which changes packaging and sometimes excipient chemistry
This is why supplier mapping must be done at the finished-product level (market/label strength, dosage form, and manufacturer listed on-country).
What procurement signals matter for sulfasalazine supply continuity?
For R&D and investment due diligence, procurement teams typically validate:
- API DMF status and right-to-reference (where applicable)
- Batch-to-batch impurity profile controls and the supplier’s specification limits
- Stability program commitments (API and finished product)
- Hold-time policies for intermediates and bulk tablets
- Packaging compatibility (moisture ingress and desiccant need)
Market-ready supplier diligence checklist for azulfidine (sulfasalazine)
Use these proof points to identify real suppliers for a specific country and dosage strength:
| Diligence item |
What to request |
What it confirms |
| Finished product manufacturer on pack label |
Manufacturer name and address |
Who is accountable for the market product |
| Regulatory listing identifiers |
Application holder/manufacturer code (by jurisdiction) |
Which product-specific manufacturing site is in play |
| DMF cross-reference (if available) |
DMF number and name of API site |
Which API site supplies the product |
| COA and impurity sets |
Latest 3 to 5 COAs for API |
Supplier’s impurity control and repeatability |
| Stability protocol and results |
API and finished product stability reports |
Shelf-life support for the formulation |
| GMP audit scope |
Certificate scope and audit summary |
Whether the supplier can sustain long-term delivery |
What suppliers are typically involved along the sulfasalazine chain?
Even without a verifiable supplier list in this chat, the practical chain for sulfasalazine finished-dose is usually structured as:
- API manufacturer → API distributor/trader (optional) → finished-dose manufacturer → packager → marketing authorization holder / distributor → wholesaler pharmacies
Supplier concentration risk usually sits at:
- API production sites
- single-source excipient suppliers for key critical excipients
- packaging material suppliers with long lead times
Key Takeaways
- “Azulfidine suppliers” must be decomposed into API suppliers and finished-product/packaging/excipient suppliers; “one supplier” rarely captures reality.
- A complete, accurate supplier roster cannot be established from the information provided here.
- For due diligence, the fastest path to supplier identification is through finished-product label manufacturers and regulatory listings, then mapping to API DMF sites and validating via COAs and impurity profiles.
FAQs
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Is the supplier list for Azulfidine the same worldwide?
No. Supplier identity changes by country, manufacturer listed on-pack, and whether the market is supplied by multiple finished-dose sites.
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Who is the most critical supplier for Azulfidine continuity risk?
The sulfasalazine API manufacturing site, because API specifications, impurity controls, and lead times tend to be the binding constraints.
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What documents most directly identify the sulfasalazine API supplier?
Regulatory filings that reference an API DMF and API COAs that show consistent impurity and specification compliance.
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Do excipient suppliers change more often than API suppliers?
They can. Excipients often have broader qualified supplier bases, so firms may switch vendors while maintaining the same formulation controls.
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Does packaging materially affect Azulfidine supply decisions?
Yes. Moisture and stability requirements can drive desiccant, container closure, and blister material choices, which can create single-source packaging constraints.
References
[1] U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
[2] European Medicines Agency. Public assessment reports and product information for sulfasalazine-containing medicines.
[3] FDA. Drug Master File (DMF) regulatory framework and guidance for API submissions.
