Last updated: June 2, 2026
NYSTOP suppliers map (nitostyrene topical powder, nystatin topical)
Executive summary: NYSTOP (nystatin powder, topical antifungal) is supplied primarily through branded manufacturers that control the underlying drug substance and fill-finish for the marketed powder. Competitive supply is typically constrained by (1) nystatin raw material availability, (2) topical powder formulation know-how, and (3) FDA manufacturing-site and labeling registrations. For procurement and contracting, the most reliable supplier view is tied to the current FDA label’s listed manufacturer and NDA holder/marketing authorization, then expanded via the FDA “Drug Shortages” and wholesaler catalog SKUs.
Who supplies NYSTOP (nystatin) powder in the U.S.?
Most NYSTOP supply in the U.S. comes from the labeled manufacturer(s) named on the current FDA-approved prescribing information for NYSTOP. The “supplier” designation is effectively the company operating the NDA label/marketing authorization for the commercial product.
How do NYSTOP suppliers get identified in procurement practice?
- The NDA label and current prescribing information identify the “Manufactured for” and/or “Distributed by” entities for each market package.
- The NDC-linked product listing identifies the firm tied to that NDC’s label.
- Wholesalers may show multiple sources only when there is relabeled supply or parallel distribution; true drug-product manufacturing changes are less common.
Primary supply chain nodes
- Drug substance: nystatin production (often by specialized fermentation and purification suppliers).
- Drug product: topical powder manufacturing and packaging (blending, milling, sieving, filling, and QA release).
- Secondary packaging and distribution: label management for the finished marketable presentation.
What ingredients and product form drive NYSTOP sourcing requirements?
NYSTOP is a topical antifungal powder containing nystatin. Sourcing is therefore tied to nystatin powder manufacturing and topical powder compliance.
Are there different NYSTOP strengths or dosage forms that change suppliers?
Supply sources can differ by:
- Presentation (jar vs bottle vs pack size)
- NDC (each NDC often maps to a specific labeler/manufacturer)
- Manufacturing site changes, which trigger updated labeling and can shift the NDC-to-supplier mapping
Which companies supply NYSTOP through authorized labeling and NDCs?
NYSTOP sourcing is best confirmed by mapping:
- NDC (National Drug Code) to labeler/manufacturer on the package
- Current prescribing information “manufactured for” and “distributed by” lines
How many supplier entities typically appear per NYSTOP NDC?
Often one, unless:
- The product is marketed by multiple labelers over time (labeler swaps)
- An authorized repack relabel occurs
- Contract manufacturing changes occur, resulting in an NDC re-link to a different firm
What suppliers compete with NYSTOP (nystatin topical powder) when branded supply tightens?
When NYSTOP supply is constrained, the practical alternative set is:
- Generic topical nystatin powder products with equivalent strength and dosage form
- Compounding pharmacies producing nystatin topical powder under state pharmacy compounding rules (less common for routine hospital procurement)
- Alternative antifungal powders or creams depending on indication and payer formulary
Do NYSTOP substitutes change the procurement supplier?
Yes. Procurement often shifts from the branded manufacturer to:
- The generic labeler/manufacturer supplying the NDC(s) in shortage windows
- Regional distributors carrying available NDCs
What does FDA regulatory status imply for NYSTOP suppliers?
NYSTOP’s FDA status ties supplier legality to the approved NDA holder and current Good Manufacturing Practice manufacturing sites.
Orange Book and exclusivity: how that affects suppliers
If NYSTOP is listed with exclusivity and patents in the Orange Book, new entrants for “same drug, same dosage form” typically require ANDA pathways for generics. In procurement terms, that means supplier diversity is limited to:
- Current ANDA/generic labelers with bioequivalence/quality approvals
- Branded manufacturer unless labeler/manufacturer swaps occur
What manufacturing/IP barriers limit NYSTOP supplier churn?
Topical powder products face manufacturing barriers tied to:
- Controlled particle size and uniformity
- Stability of nystatin and excipient blend
- Bulk powder handling and contamination controls
- QA release testing and container closure integrity for powders
How to assess NYSTOP supplier reliability for contracts and hospital procurement
A high-reliability sourcing program uses:
- NDC-level supplier mapping (not just brand-level)
- FDA shortage monitoring (if active)
- Lot traceability and QA record acceptance
- Purchase order flexibility across NDCs (when multiple NDCs are in circulation)
NYSTOP supplier risk checklist
- FDA “Drug Shortages” status for each relevant NDC
- Manufacturing site continuity for the NDC (site changes can increase lead times)
- Distributor fill-rate history for each NDC
- Recalls or quality alerts tied to the specific lot/NDC
Key Takeaways
- NYSTOP suppliers are primarily the labeled NDA brand manufacturer/distributor named on current labeling for the NDCs in market circulation.
- Supplier diversity typically shows up at the NDC level, not the brand level.
- When NYSTOP supply tightens, procurement usually moves to generic nystatin topical powder labelers/manufacturers with available NDCs.
- The biggest practical constraints on supplier churn are FDA compliance tied to manufacturing sites and powder formulation/fill-finish controls.
FAQs
- Which NDCs correspond to NYSTOP and which firms label them?
- What generic nystatin topical powders substitute for NYSTOP in hospital formularies?
- How do FDA drug shortages change NYSTOP sourcing options by NDC?
- What labeling lines (“manufactured for” vs “distributed by”) should procurement teams capture for NYSTOP contracts?
- Do NYSTOP generic entries face Paragraph IV challenges or exclusivity barriers affecting supplier availability?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
- U.S. Food and Drug Administration. Drug Shortages. FDA.
- FDA. Orange Book database entries and prescribing information for NYSTOP (nystatin topical powder). FDA.
