Suppliers and packagers for generic pharmaceutical drug: butoconazole nitrate

butoconazole 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
Padagis Israel	GYNAZOLE-1	butoconazole nitrate	CREAM;VAGINAL	200923	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-396-01	1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01) / 5.8 g in 1 TUBE, WITH APPLICATOR	2015-04-29
Padagis Israel	GYNAZOLE-1	butoconazole nitrate	CREAM;VAGINAL	200923	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-396-02	1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-02) / 5.8 g in 1 TUBE, WITH APPLICATOR	2015-04-29

Suppliers and packagers for generic pharmaceutical drug: butoconazole nitrate

Last updated: May 2, 2026

Who Supplies Butoconazole Nitrate for Pharmaceutical Manufacture?

Butoconazole nitrate is a topical antifungal active ingredient supplied through a mix of API specialists and chemical manufacturers that produce antifungal imidazole intermediates and convert them into the nitrate salt form. The market is typically accessed via (1) direct API purchase from API manufacturers, (2) contract manufacturing organizations (CMOs) that source API and formulate, or (3) distributor channels that consolidate multiple API grades and regulatory dossiers.

Because “butoconazole nitrate” can appear under multiple naming conventions (including salt form naming and regional pharmacopoeia descriptors), supplier coverage is most reliable when the procurement target is defined as the API butoconazole nitrate (not “butoconazole” free base) and the required grade (USP/EP/BP, if applicable), spec set, and documentation package (CoA, DMF/CEP if held) are aligned.

What types of suppliers cover butoconazole nitrate?

Supplier channel	What they typically provide	Typical buyer use case
API manufacturers	Butoconazole nitrate API (bulk) and chemical CoA	Product supply, internal formulation
Salt-form / intermediate producers	Butoconazole intermediate + salt conversion support	Builds API supply chain redundancy
Distributors / specialty chemical brokers	Consolidated sourcing, short lead times	Low-volume trials, replacement buys
CMOs for topical products	Formulated finished dosage (cream/gel) using sourced API	Launch supply, lifecycle manufacturing

Who are the common supplier categories for butoconazole nitrate?

Category	Supplier examples you should check during procurement	Notes for qualification
API chemical manufacturers	Companies producing imidazole antifungal APIs (butoconazole-class)	Confirm nitrate salt form, not free base
Regional API producers	Manufacturers in EU/Asia that list butoconazole nitrate as an API or antifungal intermediate	Validate documentation package and polymorph/salt form controls
Distributors with API portfolios	Specialty pharma ingredient distributors	Verify traceability and lot-level CoA alignment to the purchased grade

Which procurement-ready supplier dossier elements matter most?

For butoconazole nitrate, procurement teams usually qualify suppliers on documentation and quality systems tied to topical dermatology supply chains:

1. API grade and compendial target
   • Confirm the buyer’s expected monograph alignment (USP/EP/BP grade if used in the finished product specification).
2. Salt form specification
   • Ensure the supplier controls and labels nitrate salt form (not butoconazole free base).
3. Quality package
   • CoA with key tests (assay, impurities, water content if applicable, identity tests).
4. Regulatory dossier availability
   • DMF or CEP (if held by the supplier), or equivalent regulatory support documentation used by formulators.
5. Stability and handling
   • Storage conditions, shelf-life assumptions, and impurity trend reporting in place for salt-form APIs.

What specifications typically appear on butoconazole nitrate API CoAs?

While exact limits vary by supplier and grade, butoconazole nitrate API CoAs commonly track:

• Assay (API content)
• Identity (e.g., chromatographic and/or spectroscopic confirmation)
• Impurities (total impurities and individual impurity thresholds)
• Residual solvents (if synthesis uses solvent steps subject to ICH Q3C)
• Water content (often via KF or LOQ-adjusted methods)
• Heavy metals and/or sulfated ash (depending on grade/spec)
• Particle and bulk density (for formulation readiness in topical mixes)

How to map suppliers to end-product needs (topical vs API-only)

Buyer objective	Best-fit supplier model	What to demand
Buy API only for in-house formulation	API manufacturer	CoA, method summaries, impurity profile, nitrate salt confirmation
Scale-up for commercial topical cream/gel	CMO that can manage API sourcing	Finished product GMP system + linked API supply control
Secure secondary source for supply continuity	Distributor plus API manufacturer qualification	Lot traceability, documentation audit trail, change control plan

Supplier shortlisting framework for butoconazole nitrate

Use a two-tier approach in vendor qualification:

1. Tier 1: API availability and salt form proof
   • Confirm the exact purchasable item is butoconazole nitrate.
   • Validate that lab identity tests in the supplier’s CoA match your finished product spec identity tests.
2. Tier 2: dossier and quality system alignment
   • Review documentation set (CoA templates, analytical method transparency level, regulatory dossier access).
   • Confirm change-control practices for impurity profile drift and salt form control.

What does “supplier readiness” look like for butoconazole nitrate?

A supplier that is “ready to support pharma” typically provides:

• Consistent lot release testing aligned to purchaser spec
• Documented impurity control (process-related impurities) and stable analytical methods
• Traceability from synthesis batch to shipped API lot
• Packaging and labeling that supports pharma receiving requirements
• Supply continuity (lead times, MOQ flexibility, and ability to support requalification)

Key Takeaways

• Supplier coverage for butoconazole nitrate comes mainly from API manufacturers, with support via salt-form capable producers and specialty pharma distributors, and in some cases CMOs for topical finished goods.
• Qualification should prioritize exact nitrate salt form, grade/spec alignment, CoA completeness, and regulatory documentation readiness (DMF/CEP or equivalent).
• Shortlist suppliers only after verifying API identity tied to salt form and a stable impurity control program suitable for topical formulations.

FAQs

1) Is butoconazole nitrate the same as butoconazole free base?

No. “Butoconazole nitrate” is the nitrate salt form; procurement should specify nitrate form to match finished product specifications and impurity behavior.

2) Do distributors always provide the same analytical profile across lots?

Not automatically. Distributors can consolidate from multiple manufacturing sites or batches, so lot-level CoA review and identity confirmation are required.

3) What documentation matters most when buying butoconazole nitrate API?

CoA with assay/impurities and identity tests, plus regulatory dossier support (DMF/CEP or equivalent) depending on your product filing pathway.

4) Which supplier type is best for a new formulation program?

For a new topical formulation, a CMO that can manage API sourcing plus formulation and stability planning often reduces integration risk, while an API manufacturer is best for in-house development where procurement control is internal.

5) What common quality risks show up with salt-form APIs?

Salt-form variability, impurity profile drift, and inconsistent identity confirmation. These are controlled through stringent salt-form specifications and validated analytical methods tied to identity tests.

References

1. USP. USP–NF Monographs and General Chapters (latest editions). United States Pharmacopeia.
2. European Pharmacopoeia. European Pharmacopoeia (Monographs and General Chapters) (latest editions). EDQM.
3. ICH. ICH Q3C: Impurities: Guideline for Residual Solvents (current version). International Council for Harmonisation.