Last Updated: May 10, 2026

Suppliers and packagers for generic pharmaceutical drug: miconazole nitrate


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miconazole nitrate

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Perrigo R And D MICONAZOLE NITRATE miconazole nitrate CREAM, INSERT;TOPICAL, VAGINAL 079114 ANDA Target Corporation 11673-199-00 1 KIT in 1 CARTON (11673-199-00) * 1 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE 2010-07-08
Perrigo R And D MICONAZOLE NITRATE miconazole nitrate CREAM, INSERT;TOPICAL, VAGINAL 079114 ANDA Rite Aid Corporation 11822-1104-0 1 KIT in 1 CARTON (11822-1104-0) * 1 SUPPOSITORY in 1 POUCH (0113-3023-00) * 1 TUBE in 1 KIT (0113-8123-00) / 9 g in 1 TUBE 2021-04-07
Perrigo R And D MICONAZOLE NITRATE miconazole nitrate CREAM, INSERT;TOPICAL, VAGINAL 079114 ANDA Safeway 21130-040-00 1 KIT in 1 CARTON (21130-040-00) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE 2015-09-28
Perrigo R And D MICONAZOLE NITRATE miconazole nitrate CREAM, INSERT;TOPICAL, VAGINAL 079114 ANDA Kroger Company 30142-199-00 1 KIT in 1 CARTON (30142-199-00) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE 2010-06-08
Perrigo R And D MICONAZOLE NITRATE miconazole nitrate CREAM, INSERT;TOPICAL, VAGINAL 079114 ANDA Topco Associates LLC 36800-199-00 1 KIT in 1 CARTON (36800-199-00) * 1 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE 2010-06-17
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for generic pharmaceutical drug: miconazole nitrate

Last updated: April 23, 2026

Who supplies miconazole nitrate for pharmaceutical use?

Miconazole nitrate is a widely supplied active pharmaceutical ingredient (API) used in topical antifungal products. Supplier coverage typically splits into three lanes: (1) API manufacturers that sell miconazole nitrate directly, (2) API distributors trading finished raw material, and (3) contract manufacturers supplying conforming API under controlled documentation (often via distribution channels).

Market-ready supplier list (API/distribution lanes)

Category Supplier What they supply Notes relevant to buyers
API/distribution Alfa Aesar (Thermo Fisher Scientific) Miconazole nitrate Common for research and supply-chain qualification; check grade and documentation set for commercial use.
API/distribution TCI Chemicals Miconazole nitrate Typically sold with standard chemical documentation; qualification needed for API-grade requirements.
API/distribution Sigma-Aldrich (Merck) Miconazole nitrate Often offered for lab-scale purchases; verify API-grade specs and regulatory documents.
API/distribution VWR / Avantor Miconazole nitrate Acts as a channel distributor for commodity/regulatory chemical supply depending on SKU.
API/distribution Cayman Chemical Miconazole nitrate Research-grade supply; buyers must confirm suitability for pharmaceutical manufacturing.
API/distribution MedChemExpress Miconazole nitrate Research procurement channel; verify documentation and specs.

Commercial/pharma-grade sourcing reality

  • Miconazole nitrate is generally easier to source through chemical distributors and branded catalog suppliers than through direct single-site API contracting, unless the buyer qualifies a specific API manufacturer for commercial supply.
  • Buyers should expect SKU-specific documentation (CoA, specification sheet, impurity profile, residual solvents, polymorph/hydrate claims where applicable) and should treat “catalog availability” as separate from pharmaceutical-grade release.

Which supplier types sell miconazole nitrate?

API manufacturers

Direct API manufacturers provide commercial-grade miconazole nitrate for pharmaceutical formulations, usually with:

  • GMP manufacturing control (or equivalent quality systems)
  • Batch CoA with predefined specs
  • Impurity profiling (process- and degradation-related)
  • Controlled packaging and traceability

Authorized distributors

Distributors supply:

  • API under their import and distribution controls
  • Batch-level documentation via their source
  • Often faster procurement and stable SKU availability for non-clinical and early development

Research chemical suppliers

Chemicals marketed for research sale:

  • Lower friction procurement
  • Variable alignment to API-grade expectations
  • Often no GMP batch documentation unless the buyer selects a specific compliant grade or route

How to vet miconazole nitrate suppliers for pharmaceutical use

Quality and compliance documentation

Prioritize suppliers that can provide, per batch:

  • CoA matching your intended use (API acceptance criteria)
  • Specification sheet (assay, related substances, water content if applicable, particle size if claimed)
  • Analytical methods or validated method references where required
  • Impurities and impurity limits consistent with your development stage

Manufacturing and traceability

Require:

  • Manufacturing site identification and batch traceability
  • If applicable, GMP status for the manufacturing step that produces the API grade you intend to buy
  • Confirmation of packaging, storage conditions, and shelf life

Regulatory alignment

For pharma projects, ensure:

  • The seller can support regulatory-grade documentation for your filing needs (for example, DMF/ASMF support is not always available through retail-style chemical channels)

Where buyers typically place orders for miconazole nitrate

Best-fit procurement channels

  1. Pharma-distribution catalog suppliers for API-grade documentation readiness.
  2. Large chemical suppliers when you need fast availability and can qualify the grade to internal specs.
  3. Direct contracting with an API manufacturer when you need multi-year supply, validated GMP consistency, and pre-defined impurity controls.

Procurement outcomes

  • Development and scale-up typically uses distributor supply for continuity, then locks a primary manufacturer for commercial stability.
  • Commercial supply almost always consolidates into a small number of qualified sources after audit/qualification.

Key Takeaways

  • Miconazole nitrate is commonly sourced through major chemical suppliers and pharmaceutical distribution channels; supplier suitability depends on whether the buyer needs API-grade and GMP-grade documentation, not just catalog availability.
  • Use the supplier-grade table above as the starting set for sourcing, then qualify by CoA/spec matching, impurity profiling, traceability, and GMP alignment.
  • Commercial projects generally transition from distributor procurement to qualified API manufacturers once stability and regulatory documentation needs are defined.

FAQs

1) Is miconazole nitrate widely available from chemical suppliers?

Yes. Multiple global catalog suppliers list miconazole nitrate, but pharmaceutical-grade suitability depends on the specific SKU and documentation.

2) Do distributors sell GMP miconazole nitrate automatically?

Not automatically. Distributors can carry different grades. Buyers must confirm the intended API grade, CoA/spec, and GMP-alignment documentation for each batch.

3) Which documentation is most important for qualification?

The batch CoA against your acceptance criteria, the supplier specification sheet, impurity profile/limits, and traceability to the manufacturing site and batch.

4) Can I buy miconazole nitrate for early development from research suppliers?

Often yes for formulation screening, but buyers must qualify the grade to their internal specs for any regulatory or later-stage use.

5) How many suppliers should a pharmaceutical buyer qualify for continuity?

Typically more than one, but the exact number is driven by risk tolerance and supply-chain resilience needs for your target volumes and region.


References

[1] Thermo Fisher Scientific. Alfa Aesar product listing for miconazole nitrate.
[2] TCI Chemicals. Product listing for miconazole nitrate.
[3] Merck. Sigma-Aldrich product listing for miconazole nitrate.
[4] Avantor/VWR. Product listing for miconazole nitrate.
[5] Cayman Chemical. Product listing for miconazole nitrate.
[6] MedChemExpress. Product listing for miconazole nitrate.

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