Suppliers and packagers for generic pharmaceutical drug: NYSTATIN

NYSTATIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	NYSTATIN	nystatin	CREAM;TOPICAL	219527	ANDA	Aurobindo Pharma Limited	59651-907-14	1 TUBE in 1 CARTON (59651-907-14) / 15 g in 1 TUBE	2025-03-21
Aurobindo Pharma	NYSTATIN	nystatin	CREAM;TOPICAL	219527	ANDA	Aurobindo Pharma Limited	59651-907-30	1 TUBE in 1 CARTON (59651-907-30) / 30 g in 1 TUBE	2025-03-21
Cosette	NYSTATIN	nystatin	CREAM;TOPICAL	061966	ANDA	Cosette Pharmaceuticals, Inc.	0713-0678-15	1 TUBE in 1 CARTON (0713-0678-15) / 15 g in 1 TUBE	2015-04-01
Cosette	NYSTATIN	nystatin	CREAM;TOPICAL	061966	ANDA	Cosette Pharmaceuticals, Inc.	0713-0678-31	1 TUBE in 1 CARTON (0713-0678-31) / 30 g in 1 TUBE	2015-04-01

Suppliers and packagers for generic pharmaceutical drug: NYSTATIN

Last updated: April 24, 2026

Who supplies Nystatin (pharmaceutical-grade) and how is it sourced?

Nystatin is supplied through a mix of (i) originator-brand channels and (ii) generic manufacturing and active pharmaceutical ingredient (API) supply chains. The manufacturer landscape is largely split between finished-dose producers (tablets, oral suspension, topical formulations) and API producers who sell nystatin for formulation. Because procurement is product- and jurisdiction-specific, buyer qualification is typically governed by the finished dose’s marketing authorization holder (MAH) and the API traceability chain (DMF, CEP, or equivalent dossier submission).

What are the main supplier types for nystatin?

Supply layer	What the supplier sells	Typical buyer	What to verify
Finished-dose manufacturer (FDF)	Tablets, oral suspension, creams/ointments	Brand/generic marketers, distributors, hospital group purchasers	MAH/marketing authorization, labeling, GMP, local product registration, batch release documentation
API manufacturer	Nystatin API (raw material)	Formulators, contract manufacturers (CDMOs), wholesalers sourcing APIs	DMF/CEP status, polymorph/grade spec, impurity profile, CoA, GMP status in buyer’s jurisdiction
Contract manufacturers / packers	Filled-pack finished goods, secondary packaging, labeling	Brand owners without manufacturing assets	Pack site GMP, traceability to API CoA and batch records

Which companies supply nystatin in the market?

A complete, current “global supplier list” requires product registration and shipment-level data. The supplier roster below reflects widely used, recurring market participants for nystatin API and finished products that appear in commercial distribution channels and regulatory dossiers. This is the practical supplier universe buyers qualify against during sourcing.

API and bulk nystatin manufacturers (common qualification targets)

Supplier	Supplier role	Market footprint (typical)	Notes buyers usually apply
Hetero Labs	API and/or finished-dose supply	Large-scale generic production	Often appears in generic antifungal portfolios; check jurisdiction registration and DMF chain
Aurobindo Pharma	API and/or finished-dose supply	Broad global generics footprint	Verify grade, impurities, and specific nystatin form used by the target FDF
Teva (Actavis channel historically)	Finished-dose distribution (jurisdiction-dependent)	Multi-country supply	Confirm whether Teva supplies the finished dose or only distribution for a given market
Torrent Pharmaceuticals	Finished-dose supply (jurisdiction-dependent)	India and export footprint	Confirm pack strength and local regulatory status
Mylan / Viatris legacy	Finished-dose supply (jurisdiction-dependent)	Global generic supply	Validate which strength form is covered and packaging site
Sandoz / Novartis generics channel (jurisdiction-dependent)	Finished-dose supply	EU and other regulated markets	Verify MAH and batch release responsibilities
Micro Labs	Finished-dose supply	India and export footprint	Confirm product type (oral vs topical) and formulation base
Cadila (Zydus) channel (jurisdiction-dependent)	Finished-dose supply	India and export footprint	Validate registration class and excipient set for bioequivalence and stability

Finished-dose suppliers (brand and generic channels)

Supplier	Typical product positioning	Where buyers see it	Procurement focus
Multi-national generic companies	Generic tablet/oral suspension and topical forms	US/EU/Canada procurement channels	MAH clarity, pack size, and local substitution rules
Large Indian generic producers	Tablets, suspensions, creams/ointments	Tender and distributor channels	Batch release documentation, shelf-life, and storage requirements
Regional EU and APAC firms	Local brand or generic distribution	National formularies	Local registration and reimbursement status

What product forms drive supplier selection for nystatin?

Nystatin supply is constrained by dosage form and packaging:

Dosage form	Procurement implications
Tablets	Requires validated tablet strength, tablet hardness and dissolution specs; stability and shelf-life controls dominate
Oral suspension	Higher sensitivity to viscosity, uniformity, microbial control, and container-closure integrity
Topical cream/ointment	Requires excipient compatibility, spreadability and rheology specs; microbial and preservative controls apply where relevant

Key regulatory and quality gates buyers use (supply qualification checklist)

API sourcing

• Dossier route: DMF or CEP (or equivalent regulatory evidence for buyer’s jurisdiction).
• GMP compliance: API manufacturing site GMP certificate and scope alignment to nystatin.
• Quality specs: identification, assay, impurities, water content, and polymorph/particle spec (as applicable).
• CoA traceability: batch-level traceability from API to FDF batch record.

Finished-dose sourcing

• MAH responsibility: confirm who holds the marketing authorization in the target country.
• Batch release: ensure local release arrangements and distribution chain integrity.
• Packaging: confirm container-closure system and printed label compliance.
• Stability: ensure shelf-life and transport conditions align with buyer’s channel.

How to evaluate supplier fit: commercial decision matrix

Use the same criteria across candidates to minimize qualification friction:

Criterion	What it determines
Regulatory status in target country	Whether you can list the product for tender or formulary
Manufacturing continuity	Ability to maintain supply through demand spikes
Analytical alignment	Whether specifications match your formulation and QC release
Lead time and batch frequency	Whether you can run rolling safety stock
Documentation completeness	Ease of QA release and downstream audits

Key Takeaways

• Nystatin procurement splits into API supply (DMF/CEP and GMP-led qualification) and finished-dose supply (MAH-led product registration and batch release).
• The effective supplier universe is jurisdiction- and dosage-form-specific (tablets vs oral suspension vs topical formulations).
• Buyers should qualify on dossier evidence, GMP scope, batch traceability, and stability/packaging integrity, not only on manufacturer capability claims.
• In practice, sourcing routes typically lead to large generic manufacturers and their supply chains (API and/or FDF) plus regional distributors that hold local marketing authorizations.

FAQs

1. Is nystatin supplied mainly as an API or finished dose?
   Both. APIs are used by formulators/CDMOs, while most procurement for healthcare systems is for registered finished-dose products (tablets, oral suspension, topical).

2. What is the most critical documentation in nystatin supply qualification?
   Batch-level CoA traceability tied to the registered product chain, supported by API and/or finished-dose regulatory dossier evidence (DMF/CEP or local authorization documentation).

3. Do API and finished-dose suppliers have to be the same company?
   No. Finished-dose manufacturers often source API from one set of API suppliers and produce final products via their own or contract manufacturing networks.

4. Which nystatin dosage forms are hardest to source?
   Oral suspension and some topical presentations can be harder due to container-closure integrity, microbial controls, and tighter stability and formulation consistency requirements.

5. How do buyers reduce supply disruption risk for nystatin?
   They qualify multiple suppliers by dossier and GMP scope, maintain safety stock, and require documentation completeness for rapid QA batch release.

References

[1] European Medicines Agency. Assessment history and public assessment reports (varies by product). EMA website.
[2] U.S. FDA. Drug shortages database and drug product information (varies by dosage form and labeler). FDA website.
[3] World Health Organization. WHO Model Guidance on quality and regulatory documentation for pharmaceutical APIs and finished products (general framework). WHO website.
[4] EMA. CEP and APIMF information resources (general guidance for API qualification). EMA website.