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Suppliers and packagers for DIFLUCAN
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DIFLUCAN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer | DIFLUCAN | fluconazole | FOR SUSPENSION;ORAL | 020090 | NDA | Roerig | 0049-3450-19 | 1 BOTTLE in 1 CARTON (0049-3450-19) / 35 mL in 1 BOTTLE | 1993-12-23 |
| Pfizer | DIFLUCAN | fluconazole | FOR SUSPENSION;ORAL | 020090 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 59762-5029-1 | 1 BOTTLE in 1 CARTON (59762-5029-1) / 35 mL in 1 BOTTLE | 1993-12-23 |
| Pfizer | DIFLUCAN | fluconazole | FOR SUSPENSION;ORAL | 020090 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 59762-5030-1 | 1 BOTTLE in 1 CARTON (59762-5030-1) / 35 mL in 1 BOTTLE | 1993-12-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
DIFLUCAN (fluconazole) API and Finished-Dose Suppliers: Who Produces It and What Inputs Matter
Executive summary: Diflucan is fluconazole. Core supply is split between (1) API manufacturers making fluconazole (including “intermediate-to-API” supply chains) and (2) finished-dose packagers/blenders producing tablets and suspensions. Patent status and FDA labeling drive finished-dose sourcing, while API availability and grade (USP/EP/ICH) drive commercial continuity. The supplier set is typically global, with multiple qualified API sources supporting branded and generic production.
Who supplies the fluconazole API used to make Diflucan?
Fluconazole is a widely manufactured azole antifungal API with broad industrial capacity. Suppliers are generally qualified for branded and generic manufacturers via DMF/CEP pathways and supplier audits, with ongoing qualification tied to compliance history, impurity profiles, polymorph/particle specs, and stability.
What determines fluconazole API supplier qualification?
- Compliance status: cGMP for API manufacture, quality agreements, audit cadence.
- Control strategy: known impurities and limits (process-related and degradation-related).
- Physical specs: particle size distribution, polymorphic form, bulk density, moisture content.
- Analytical alignment: impurity thresholds by ICH Q3A/Q3B and compendial methods.
- Regulatory dossiers: FDA DMFs (where used), CEPs, and DMF cross-references by finished-dose applicants.
How are API suppliers categorized for fluconazole?
- End-to-end API makers (intermediate-to-API): control the critical steps that set impurity and polymorph risk.
- Intermediate-specialists: sell upstream intermediates to finishers.
- Contract manufacturers with “qualified” API grades: sell fluconazole to multiple finished-dose packagers.
Which companies manufacture and package Diflucan finished tablets and suspension?
Finished Diflucan is produced and released by the branded holder’s manufacturing and packaging network (often via contract manufacturing organizations). Finished-dose manufacturing includes:
- tablet blending and compression line capability,
- suspension formulation and viscosity control,
- microbiological quality controls,
- packaging and labeling line capability.
What packaging formats does Diflucan require supply coverage for?
- Tablets (strength variants)
- Oral suspension (viscosity, preservative system, shelf-life controls)
- Unit dose and bulk packaging compatibility with distribution networks
Why finished-dose suppliers matter more than API for shelf continuity
API may be globally available, but finished-dose continuity depends on:
- line capacity,
- change control tolerance,
- stability data for the specific formulation,
- packaging component supply (bottles, caps, syringes/spoons where used).
What are the main supply-chain input categories behind Diflucan (fluconazole)?
Diflucan supply is driven by fluconazole API plus excipients and packaging components.
What excipients create supplier bottlenecks for fluconazole oral products?
- Tablet excipients (binder/disintegrant/lubricant systems) that set dissolution performance
- Suspension excipients that drive:
- suspension homogeneity,
- viscosity and sedimentation profile,
- pH control and chemical stability of fluconazole,
- preservative performance (if used in the specific labeled product)
How does packaging supply affect availability?
- Bottle and closure component availability
- Induced demand during supply constraints often comes from packaging lead times rather than API.
Which generic fluconazole suppliers compete for the same API capacity?
Because fluconazole is off-patent in many markets and widely generic, API capacity is frequently shared across:
- generic tablet manufacturers,
- generic suspension producers,
- hospital-focused brands and private-label.
How does this affect Diflucan procurement leverage?
Branded procurement tends to be resilient via long-term contracts and preferred scheduling, but any API-wide shortage can propagate through all azole makers because fluconazole is an interchangeable commodity at the supplier level (subject to grade and dossier fit).
What is the Orange Book status of Diflucan and how does it affect supplier selection?
Orange Book listings control applicant eligibility for FDA-approved generics and branded manufacturing. Diflucan’s brand exclusivity and patent listings affect which applicants can file ANDAs early and how suppliers are locked into branded release schedules versus generic competition.
What does Orange Book status change for “suppliers”?
- It changes which finished-dose applicants are allowed to market based on patent certifications.
- It also influences contract manufacturing demand shifts from branded to generic as patent barriers fall.
What FDA chemistry-manufacturing controls constrain API switching for fluconazole?
A finished-dose manufacturer can change API supplier only if:
- the new API source is already covered by the approved control strategy or
- comparability is demonstrated for chemistry, quality, and performance (including impurity profile and dissolution).
Key switching constraints
- Matching impurity profile and limits
- Solubility-related performance impact
- Batch-to-batch consistency under the approved control strategy
- Stability under proposed storage and with the specific excipient/preservative system
How do supplier qualification and DMF/CEP pathways impact fluconazole availability?
Companies typically source fluconazole from suppliers whose documentation supports:
- regulatory filings used by the finished-dose manufacturer,
- compendial alignment (USP/EP),
- stability and impurity controls.
What is the operational effect of DMF reliance?
If a finished-dose applicant references a specific API DMF route, it can take time to qualify an alternate supplier that has a matching dossier and quality system.
What manufacturing and quality risks drive supplier diversification in fluconazole?
Common risk triggers include:
- contamination events in supplier facilities,
- inability to meet impurity specifications due to process variation,
- changes in polymorphic behavior or particle size distributions,
- component shortages for packaging.
Where do rare failures tend to show up?
- suspension batches due to viscosity/homogeneity shifts when excipient lots change,
- dissolution or bioequivalence sensitivity if API physical form shifts.
What biosimilar or biologics risk exists for Diflucan sourcing?
Diflucan is a small-molecule antifungal (fluconazole), not a biologic. Biosimilar risk does not apply. Competitive risk is from generics and authorized equivalents.
Key Takeaways
- Diflucan supply is an API plus excipient and packaging problem, not a biologics problem.
- Fluconazole API is widely manufactured globally; supplier qualification depends on impurity control, physical form, and regulatory dossier fit.
- Finished-dose continuity depends on packaging lead times, suspension formulation controls, and release testing capacity.
- Orange Book and patent listings shape competitive demand, indirectly affecting how procurement prioritizes branded versus generic manufacturing throughput.
FAQs
- Do tablet and suspension forms require different fluconazole API specs?
- How quickly can a finished-dose maker qualify an alternate fluconazole API supplier under FDA controls?
- What excipient categories most often drive quality complaints in fluconazole suspensions?
- Can packaging component shortages cause Diflucan availability issues even when API supply is stable?
- How do impurity profile differences between fluconazole API lots affect batch release?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).
- FDA. Drug Master Files (DMF) guidance and information. (Accessed 2026).
- FDA. ANDA Chemistry, Manufacturing, and Controls (CMC) requirements and guidance for ANDAs. (Accessed 2026).
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