Suppliers and packagers for sulfadiazine

sulfadiazine

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chartwell Molecular	SULFADIAZINE	sulfadiazine	TABLET;ORAL	080084	ANDA	Chartwell RX, LLC	62135-842-60	60 TABLET in 1 BOTTLE (62135-842-60)	2024-09-23
Epic Pharma Llc	SULFADIAZINE	sulfadiazine	TABLET;ORAL	040091	ANDA	EPIC PHARMA, LLC	42806-757-60	60 TABLET in 1 BOTTLE (42806-757-60)	2021-12-15

Suppliers and packagers for sulfadiazine

Last updated: April 25, 2026

Who Supplies Sulfadiazine for Pharmaceutical Use?

Sulfadiazine is a long-established, widely traded sulfonamide API used in human and veterinary products. Supply is concentrated across multi-purpose chemical/API producers, specialty generics, and regional distributors. The practical supply chain breaks into two layers: (1) API manufacturers that produce or source sulfadiazine (free base) and (2) distributors and formulation-grade suppliers that fulfill commercial packaging needs (often with documentation for regulated use).

What Does the Supply Base Look Like?

API manufacturers and chemical producers

Sulfadiazine supply typically comes from:

• API-grade sulfonamide producers with broad sulfonamide portfolios (often also sell sulfamethoxazole, sulfadiazine salts, or sulfonamide intermediates).
• Generic API producers that offer sulfadiazine as an “older/legacy” product line with stable volumes and documentation packages.
• Regional chemical manufacturers that produce sulfadiazine under domestic standards and sell into distribution networks.

Because sulfadiazine is older and frequently sourced through global commodity-grade channels, many “brand name” suppliers do not manufacture the API themselves. They compile commercial lots from producers and provide COAs, SDS, and regulatory dossiers for customers.

Distributors and chemical trading houses

Most regulated buyers encounter sulfadiazine through distributors that:

• Maintain ready inventory across multiple packaging formats (commonly 25 kg and 1,000 kg, depending on grade and region).
• Provide SDS, COA, and often an updated regulatory status letter for quality and compliance workflows.
• Support vendor qualification by providing traceability and audit packages when required.

Which Supplier Categories Matter for Pharmaceutical R&D and Procurement?

Category 1: API manufacturers (direct sourcing)

Procurement from an API manufacturer is best when the buyer needs:

• Direct technical agreements for specs (assay, impurities, particle size if applicable).
• Stable long-term supply volumes and consistent control strategy.
• Access to manufacturing site documentation for regulatory submissions.

Category 2: Quality-forward distributors (regulated fulfillment)

Procurement from a distributor is best when the buyer needs:

• Faster lead times and smaller lot flexibility.
• Standard documentation packages and batch traceability.
• Commercial throughput with fewer onboarding steps.

Category 3: Specialty excipient-formulation suppliers (if bundled)

Sometimes sulfadiazine is bundled into:

• Combination products or pre-blended formulations for veterinary or dermatology uses.
• Local formulation supply chains where sulfadiazine is sourced and repackaged.

What Specifications Do Buyers Typically Expect?

Sulfadiazine for pharmaceutical-grade supply generally aligns to pharmacopeial expectations (USP/EP/BP depending on market) and includes:

• Assay (content of sulfadiazine)
• Related substances/impurities (individual impurity limits and total impurity limits)
• Water/LOD where required by method
• Residue on ignition (for solid APIs)
• Particle size and/or sieve analysis where relevant to downstream blending
• Microbiology (more common for formulated products; API requests vary)
• Heavy metals and residual solvents (method- and process-dependent)

In practice, supplier qualification is based on the specific controlled specification set, not only the nominal pharmacopeia label.

What Are the Primary Use Profiles Driving Supply?

Sulfadiazine supply remains steady due to recurring demand in:

• Veterinary antibacterials (long-running demand in livestock and companion animal segments)
• Dermatology and wound-related formulations in some markets
• Legacy human formulations in certain geographies and tender-driven channels

This demand profile pulls suppliers into two modes: steady commodity trading for distributors and contract/volume manufacturing for direct API buyers.

How to Identify the Right Supplier Channel (Actionable Procurement Filters)

1) Regulatory readiness

For regulated pharma use, the buyer typically requires:

• Batch-specific COA with validated methods and impurity reporting
• SDS consistent with GHS classification
• GMP status (manufacturing site and quality system assertions)
• If needed for submissions: supporting documentation such as DMFs or equivalent dossiers (varies by jurisdiction)

2) Quality fit

For formulation readiness, buyers commonly validate:

• Particle size or polymorph consistency if relevant to dissolution performance
• Impurity profile stability across lots
• Solvent/water controls aligned to the buyer’s downstream process

3) Supply continuity

Sulfadiazine is mature. The key procurement risk becomes:

• Lot-to-lot impurity variability from legacy processes
• Packaging and shipment controls that affect moisture and stability

What’s the Practical Supplier Landscape in the Current Market?

Global multi-product chemical/API producers

These suppliers dominate because sulfadiazine is a “catalog” item that fits:

• Existing sulfonamide manufacturing platforms
• Established impurity control knowledge
• Lower incremental qualification costs for buyers who already source related sulfonamides

Specialty generics and legacy-API firms

These suppliers often:

• Offer sulfadiazine as part of a broader legacy antibiotic/API portfolio
• Provide regulatory documentation packages for repeat purchasing
• Run smaller, steadier campaigns depending on contract demand

Distribution networks with compliance documentation

For many pharma buyers, the distributor is the operational interface:

• They coordinate logistics, documentation, and batch traceability
• They offer alternative sourcing options if a direct API producer’s lead times drift

Where Does Sulfadiazine Typically Sit in Commercial Trade?

Sulfadiazine is commonly traded as a solid API in industrial packaging. The supply chain usually includes:

• API producer to exporter/importer
• Distributor repackaging or relabeling for customer-specific logistics
• Procurement via tender or contract batches

This model favors suppliers with:

• Consistent analytical reporting
• Documented chain-of-custody
• Predictable lead times

Key Takeaways

• Sulfadiazine supply is dominated by catalog API producers and quality-focused distributors, with many “suppliers” acting as the regulated interface rather than the manufacturer.
• Procurement decisions hinge less on novelty and more on documentation depth, impurity profile control, and lot-to-lot consistency.
• The most reliable sourcing routes are direct API manufacturers for volume and spec control, or regulated distributors for speed and operational continuity.

FAQs

1) Are there many manufacturers of sulfadiazine API?

Yes. Sulfadiazine is a mature, widely produced sulfonamide, so the supply base is broad across chemical and API catalog producers.

2) Is sulfadiazine usually sourced directly from API manufacturers or through distributors?

Both. Direct sourcing is common for volume and tight spec control; distributor sourcing is common for lead time and documentation convenience.

3) What quality documents should buyers require for sulfadiazine?

At minimum: COA for the lot and SDS. For regulated use, buyers typically also require GMP or quality-system documentation and impurity reporting consistent with the buyer’s submission and internal specs.

4) What factors most impact downstream formulation success with sulfadiazine?

Lot consistency in assay and impurities, and any relevant solid-state or particle size attributes tied to dissolution and blending.

5) What end markets most influence sulfadiazine demand?

Veterinary antibacterials and legacy human dermatology or antimicrobial formulations in certain regions drive recurring baseline demand.

References

[1] European Medicines Agency. “Sulfadiazine” (substance information and related regulatory records). EMA. https://www.ema.europa.eu/
[2] U.S. National Library of Medicine. “Sulfadiazine” (drug substance information in substance/drug databases). PubChem. https://pubchem.ncbi.nlm.nih.gov/
[3] World Health Organization. “WHO Model List of Essential Medicines” (context for sulfonamide antibiotic use and established medicines). https://www.who.int/