Suppliers and packagers for MICONAZOLE NITRATE COMBINATION PACK

MICONAZOLE NITRATE COMBINATION PACK

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
L Perrigo Co	MICONAZOLE NITRATE COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	075329	ANDA	L. Perrigo Company	0113-0081-00	1 KIT in 1 CARTON (0113-0081-00) * 1 BLISTER PACK in 1 KIT / 3 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE	2007-04-02
L Perrigo Co	MICONAZOLE NITRATE COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	075329	ANDA	Walgreen Company	0363-0081-00	1 KIT in 1 CARTON (0363-0081-00) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE	2005-07-01
L Perrigo Co	MICONAZOLE NITRATE COMBINATION PACK	miconazole nitrate	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	075329	ANDA	Combe Incorporated	11509-0081-1	1 KIT in 1 CARTON (11509-0081-1) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE	2018-03-27

Last updated: August 2, 2025

ppliers for the Pharmaceutical Drug: MICONAZOLE NITRATE COMBINATION PACK

Introduction
Miconazole nitrate combination packs represent a critical component within the antifungal pharmaceutical market. These packs typically combine miconazole nitrate with other active ingredients to target a broader spectrum of fungal infections, streamline treatment protocols, and improve patient compliance. Understanding the top suppliers for this combination pack is essential for pharmaceutical manufacturers, distributors, healthcare providers, and investors seeking reliable sourcing channels. This comprehensive analysis profiles the leading suppliers, assesses their market presence, manufacturing capabilities, and compliance standards, providing actionable intelligence for stakeholders engaged in the pharmaceutical supply chain.

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Market Overview of Miconazole Nitrate Combination Packs

Miconazole nitrate, an imidazole antifungal agent, is widely used in topical formulations and combination therapies for superficial mycoses. The combination packs often include agents like metronidazole or corticosteroids, designed for conditions requiring multifaceted treatment. The global demand for these combination packs is driven by rising fungal infection incidences, increasing prevalence of dermatological conditions, and growing healthcare infrastructure in emerging markets (1).

The distribution and manufacturing of miconazole nitrate combination packs are concentrated among global pharmaceutical giants, regional players, and contract manufacturing organizations (CMOs). Key factors influencing supplier selection include regulatory compliance, quality assurance, manufacturing capacity, and supply chain stability.

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Top Suppliers of Miconazole Nitrate Combination Packs

1. Pfizer Inc.

• Market Presence & Capabilities
  Pfizer is a leading global pharmaceutical company with extensive experience in antifungal products. Its portfolio includes both monotherapy and combination antifungal treatments, with manufacturing facilities compliant with cGMP standards across North America, Europe, and Asia (2). Pfizer’s formulation expertise allows the production of high-quality, stable combination packs meeting stringent regulatory requirements.

• Supply Chain & Distribution
  Pfizer’s broad distribution network ensures supply availability across North America, Europe, Asia, and emerging markets. The company invests heavily in quality control and supply chain resilience, critical for pharmaceutical procurement of combination packs.

2. GlaxoSmithKline (GSK)

• Market Presence & Capabilities
  GSK’s antifungal segment includes topical and systemic antifungal formulations, with strategic focus on dermatological and infectious disease regions. GSK is known for integrating innovative drug delivery systems into their combination packs, enhancing efficacy and patient adherence (3).

• Manufacturing & Compliance
  GSK’s manufacturing plants adhere to international standards, including ISO 9001 and cGMP, ensuring high-quality production. Their global footprint spans the UK, Canada, and Asia-Pacific, supporting regional supply requirements.

3. Novartis AG

• Market Presence & Capabilities
  Novartis develops diverse antifungal therapies, including combination packs targeting dermatophyte infections. The company emphasizes research-driven formulations with proven efficacy, aligning with regulatory authorities’ mandates.

• Supply & Distribution
  Novartis maintains a robust supply chain, often partnering with CMOs for local manufacturing in various markets, ensuring regulatory compliance and rapid deployment.

4. Teva Pharmaceutical Industries Ltd.

• Market Presence & Capabilities
  As a major generic drug manufacturer, Teva supplies affordable miconazole nitrate combination packs, especially targeting emerging markets. Their extensive CMO network allows rapid scaling and flexible manufacturing of complex formulations.

• Compliance & Quality Standards
  Teva emphasizes quality management systems, with manufacturing certifications compliant with U.S., European, and other international standards, ensuring reliable sourcing.

5. Dr. Reddy’s Laboratories

• Market Presence & Capabilities
  Indian-based Dr. Reddy’s has built a significant portfolio of antifungal combination products, including miconazole nitrate-based packs. Focused on price-sensitive markets, they emphasize cost-effective yet quality-assured manufacturing.

• Supply Chain
  With manufacturing units certified by WHO-GMP and USFDA, Dr. Reddy’s supports supply stability and compliance in multiple regions.

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Emerging & Regional Suppliers

Beyond the global titans, several regional and contract manufacturing organizations serve niche markets with custom formulations. Notable players include Cipla (India), Mylan (USA), and Aurobindo Pharma (India). These manufacturers often provide flexible, cost-efficient options, especially for localized distribution or private label requirements (4).

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Regulatory & Quality Considerations

Procurement from suppliers requires rigorous evaluation of compliance with international standards such as USFDA, EMA, WHO-GMP, and local regulatory agencies. Quality assurance measures, stability testing, and batch traceability are critical for ensuring drug safety and efficacy. Suppliers with proven track records in regulatory audits, validated manufacturing processes, and consistent supply history should be prioritized.

Intellectual Property & Patent Landscape

Most miconazole nitrate combination packs are available as off-patent formulations or generic equivalents, reducing barriers to market entry and sourcing costs. However, companies must scrutinize regional patents or exclusivity rights, especially in emerging markets, to avoid infringement issues (5).

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Supply Chain & Logistics Outlook

The global supply chain for pharmaceutical combination packs faces challenges related to raw material sourcing, geopolitical risks, and logistical disruptions. Suppliers with vertically integrated manufacturing and diversified sourcing strategies mitigate risk and ensure demand fulfillment (6). Contract manufacturing arrangements tend to enhance flexibility and compliance, vital during supply chain disruptions like the COVID-19 pandemic.

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Key Factors for Evaluating Suppliers

• Regulatory Compliance: Ensure adherence to cGMP, ISO standards, and regional approvals.
• Manufacturing Capacity: Confirm ability to scale production according to demand forecasts.
• Quality Assurance: Verify quality control protocols, stability data, and batch consistency.
• Supply Chain Resilience: Assess logistics, inventory management, and geopolitical stability.
• Cost & Lead Times: Balance costs with manufacturing and delivery timelines for optimal procurement.

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Conclusion

The procurement landscape for miconazole nitrate combination packs is dominated by established pharmaceutical giants such as Pfizer, GSK, Novartis, Teva, and Dr. Reddy’s. Their proven compliance standards, extensive manufacturing capacities, and global distribution networks position them as reliable suppliers. Emerging regional manufacturers offer competitive pricing and localized supply advantages, especially in cost-sensitive sectors.

Securing stable, high-quality supply requires meticulous evaluation of regulatory adherence, manufacturing quality, and supply chain resilience. As the demand for antifungal combination therapies grows, ongoing supplier vetting and strategic partnerships will be critical for maintaining supply continuity and regulatory compliance.

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Key Takeaways

• Leading global suppliers include Pfizer, GSK, Novartis, Teva, and Dr. Reddy’s, each offering high regulatory compliance and extensive distribution capabilities.
• Regional and CMOs serve niche markets with cost-effective, flexible manufacturing options.
• Supplier qualification should prioritize quality assurance, regulatory adherence, manufacturing capacity, and supply chain stability.
• The evolving patent landscape favors generics and off-patent formulations, facilitating competitive sourcing strategies.
• Robust supply chain management and contingency planning are essential to navigate geopolitical risks and logistical disruptions.

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FAQs

1. What factors should I consider when selecting a supplier for miconazole nitrate combination packs?
Focus on regulatory compliance, manufacturing capacity, quality assurance practices, supply chain resilience, and cost efficiency.

2. Are there regional differences in supplier availability for these combination packs?
Yes, while global players dominate, regional manufacturers are prominent in emerging markets, offering localized supply and cost advantages.

3. How can I verify a supplier’s regulatory compliance?
Request and review certification documentation such as USFDA, EMA, WHO-GMP certificates, and audit reports.

4. What role do contract manufacturing organizations play in supplying these combination packs?
CMOs provide flexible manufacturing, capacity scaling, and compliance support, often serving as strategic partners for large pharmaceutical companies.

5. What potential risks exist in sourcing miconazole nitrate combination packs?
Risks include supply chain disruptions, regulatory non-compliance, patent infringement issues, and quality assurance failures. Proper due diligence mitigates these risks.

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References

[1] Global Market Insights, “Antifungal Market Size & Growth,” 2022.
[2] Pfizer Annual Report, 2022.
[3] GSK Corporate Overview, 2022.
[4] Indian Pharmaceutical Market Reports, 2022.
[5] Patent Landscape Reports, 2022.
[6] Supply Chain Resilience in Pharma, WHO Report, 2022.