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Suppliers and packagers for sulfamylon
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sulfamylon
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Rising | SULFAMYLON | mafenide acetate | CREAM;TOPICAL | 016763 | NDA | Rising Pharma Holdings, Inc. | 16571-723-12 | 1 TUBE in 1 CARTON (16571-723-12) / 113.4 g in 1 TUBE | 2020-05-18 |
| Rising | SULFAMYLON | mafenide acetate | CREAM;TOPICAL | 016763 | NDA | Rising Pharma Holdings, Inc. | 16571-723-48 | 453.6 g in 1 JAR (16571-723-48) | 2020-05-18 |
| Rising | SULFAMYLON | mafenide acetate | CREAM;TOPICAL | 016763 | NDA | Rising Pharma Holdings, Inc. | 16571-723-60 | 1 TUBE in 1 CARTON (16571-723-60) / 56.7 g in 1 TUBE | 2020-05-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for sulfamylon
Sulfamylon suppliers: who manufactures silver sulfadiazine (and where does procurement come from)?
Suppliers for sulfamylon typically mean suppliers of silver sulfadiazine (the active ingredient) and distributors that carry sulfamylon brand/generic equivalents. The procurement map is split into (1) API and finished-dose manufacturers for silver sulfadiazine creams and (2) authorized wholesalers and healthcare distributors that ship finished product into specific geographies.
Named supply reality for “sulfamylon”
- Sulfamylon is a brand name used for silver sulfadiazine topical antimicrobial creams/ointments (burn and wound indications).
- In practice, supply comes from a mix of:
- Brand holders’ finished-dose supply chains (where the brand product is still marketed)
- Generic silver sulfadiazine manufacturers for the same dosage forms
- API suppliers supplying contract manufacturers that formulate the cream
Because “sulfamylon” is a brand term and availability is geography- and formulation-dependent, procurement due diligence usually targets strength, dosage form (cream vs. ointment), concentration (commonly 1%), and packaging (tube size), plus regulatory status (approved NDA/ANDA and labeling).
Which companies supply sulfamylon (silver sulfadiazine cream) in the US and EU?
Featured snippet answer: Sulfamylon supply is typically provided by generic silver sulfadiazine manufacturers (1% topical cream) and authorized distributors, with company names varying by country and product strength/package.
US supply channels: brand vs. generic
In the US, topical silver sulfadiazine 1% products are commonly sourced via:
- ANDA-approved generic manufacturers of silver sulfadiazine cream
- Authorized distributors that list NDC-specific SKUs
Procurement teams usually build a vendor list at the NDC + strength + tube size level rather than by brand name.
EU supply channels
In Europe, supply is usually:
- Finished-dose manufacturers of silver sulfadiazine cream marketed under brand or generic labels
- Wholesalers that distribute through local tender and hospital pharmacy procurement
EU sourcing similarly depends on:
- Product presentation (cream formulation)
- SmPC labeling for wound/burn use
- Local marketing authorization status
What are the most common supplier categories for silver sulfadiazine (sulfamylon) products?
Featured snippet answer: Procurement typically breaks into three supplier categories: API suppliers, finished-dose manufacturers, and authorized wholesalers/distributors.
1) API suppliers (silver sulfadiazine)
API supply supports:
- Contract manufacturing organizations (CMOs)
- Finished-dose manufacturers that formulate creams/ointments
Key diligence items:
- API CoA, particle size specs, impurity profiles
- GMP site capability for pharmaceutical grade silver sulfadiazine
- Traceability and change-control compliance
2) Finished-dose manufacturers (cream/ointment)
This is the practical category for hospital procurement:
- Silver sulfadiazine 1% cream (and in some markets, ointment)
- Packaging compliant with local regulations
Key diligence items:
- Formulation equivalence (cream base)
- Sterility/bioburden controls where applicable to packaging
- Stability and shelf-life under labeled storage conditions
3) Wholesalers and healthcare distributors
These vendors supply hospitals and clinics:
- Tender fulfillment
- Cold-chain is usually not required for standard silver sulfadiazine creams, but storage conditions still matter
- Multiple SKUs may exist by NDC/pack size
Where can you buy sulfamylon: hospital distributors, online pharmacies, or wholesalers?
Featured snippet answer: In most healthcare procurement settings, sulfamylon is purchased through authorized healthcare distributors using product IDs (NDC in the US, MA number in the EU), not through direct-to-patient retail channels.
Institutional procurement (typical workflow)
- Pharmacy group purchasing organizations (GPOs)
- Hospital group purchasing
- Distributor catalog ordering by SKU
Retail/online procurement (typical constraints)
- Product may be sourced from multiple manufacturers
- Brand labeling may differ by market
- Substitution rules depend on local policy and procurement contracts
What dosage form and strength matter when sourcing sulfamylon?
Featured snippet answer: Confirm silver sulfadiazine strength (commonly 1%) and topical dosage form (cream vs ointment) before selecting a supplier.
Common product specification filters
- Active ingredient: silver sulfadiazine
- Strength: typically 1% (w/w)
- Dosage form: cream or ointment
- Packaging: tube size (varies by market)
- Intended indication per labeling (burn/wound)
What sourcing risks exist for sulfamylon (silver sulfadiazine) procurement?
Featured snippet answer: Main risks are manufacturer concentration, substitution quality, supply interruptions, and SKU drift (different base/packaging).
Practical risk vectors
- API supply disruptions can cascade into finished-dose shortages
- Some SKUs may be discontinued or temporarily unavailable
- Generic substitutions may change excipients and texture, affecting clinician acceptance
Mitigation used in procurement
- Multi-sourcing at the SKU/spec level
- Contract clauses for supply continuity and quality documentation
- Incoming CoA and batch release verification
How does sulfamylon compare with alternative topical antimicrobials for procurement?
Featured snippet answer: Silver sulfadiazine competes with other topical agents used in burns and wound care. Substitution decisions depend on clinical protocol, resistance patterns, and supply availability.
Adjacent procurement alternatives (by therapeutic use)
- Other topical antimicrobials
- Silver-based wound products (non-sulfadiazine formulations)
- Non-silver antiseptics or dressings
Procurement teams usually validate:
- Formulary position
- Tender price
- Stockout risk
- Expected shelf life and storage stability
Who are the typical “supplier names” you’ll see on purchase orders?
Featured snippet answer: PO vendors usually show up as either:
- a finished-dose manufacturer (on-label MAH/NDA holder) or
- a distributor/wholesaler fulfilling the SKU.
Because supplier names vary by geography and NDC/MA presentation, procurement lists are best maintained by:
- Product identifier (NDC/GTIN/pack)
- Manufacturer labeler and manufacturing site (where available)
- Distributor account used for the hospital’s procurement model
Key Takeaways
- “Sulfamylon” procurement is, in practice, procurement of silver sulfadiazine topical (commonly 1% cream) plus its specific SKU presentation.
- Supply sources split into API suppliers, finished-dose manufacturers, and authorized healthcare distributors.
- Vendor selection should be done at the dose form + strength + packaging + product identifier level to avoid SKU drift and substitution risk.
- Stock continuity depends on finished-dose manufacturer capacity and upstream API availability.
FAQs
-
What is sulfamylon active ingredient and what does that mean for supplier matching?
Sulfamylon is a brand for silver sulfadiazine, so suppliers are matched by silver sulfadiazine 1% topical specs. -
How do I source silver sulfadiazine cream for hospitals if the brand is unavailable?
Source the approved generic silver sulfadiazine cream matching strength and presentation and buy through authorized distributors. -
Can I substitute silver sulfadiazine ointment for cream without changing procurement quality?
No. Ointment vs cream can differ in excipients and performance; procurement should match the exact dosage form used in the protocol. -
What documentation should accompany sulfamylon/silver sulfadiazine shipments?
Expect CoA, batch/lot traceability, and labeled specs for strength, shelf life, storage conditions, and packaging. -
What supply chain bottlenecks most often impact silver sulfadiazine topical products?
The most common bottlenecks are upstream API supply and finished-dose manufacturer capacity, leading to SKU shortages.
References (APA)
No sources cited.
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