MONISTAT 1 COMBINATION PACK: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Medtech Products	MONISTAT 1 COMBINATION PACK	miconazole nitrate	CREAM, INSERT;TOPICAL, VAGINAL	021308	NDA	Insight Pharmaceuticals LLC	63736-013-30	1 KIT in 1 PACKAGE, COMBINATION (63736-013-30) * 9 g in 1 TUBE * 1 SUPPOSITORY in 1 POUCH	2001-06-29
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Introduction

The MONISTAT 1 COMBINATION PACK is a widely used over-the-counter medication for the treatment and relief of uncomplicated vulvovaginal candidiasis (yeast infection). Known for its single-dose convenience, it typically contains clotrimazole 10 mg within a combined formulation designed for quick and effective symptom relief. Identifying reputable suppliers for this product involves understanding the complex landscape of pharmaceutical manufacturing, licensing, and distribution channels. This article provides a comprehensive overview of the key suppliers, their roles, and the global dynamics influencing supply chains for MONISTAT 1 COMBINATION PACK.

Background and Market Overview

The MONISTAT brand, owned by Bayer AG, is a globally recognized OTC antifungal treatment. Its popularity has propelled numerous generic manufacturers to produce comparable formulations. The combination pack typically includes the active pharmaceutical ingredient (API), clotrimazole, paired with excipients and packaging materials designed for single-dose administration.

The global demand for antifungal treatments has increased due to rising awareness, urbanization, and healthcare access improvements. The primary markets for MONISTAT products encompass North America, Europe, and Asia-Pacific regions. As a result, the supply chain incorporates various stakeholders, including API producers, finished dosage form (FDF) manufacturers, packaging providers, and distribution channels.

Key Manufacturers and Suppliers of Clotrimazole API

1. Major API Producers

Clotrimazole is a well-established antifungal agent synthesized through multi-step chemical processes. A handful of companies dominate its API market, and their capabilities in quality compliance and manufacturing scale influence the availability of MONISTAT 1 COMBINATION PACK.

Cipla Limited (India):
A leading manufacturer with a robust API portfolio, Cipla supplies high-quality clotrimazole to pharmaceutical companies globally. Their manufacturing facilities adhere to Good Manufacturing Practices (GMP) and have received approvals from major regulatory agencies such as the USFDA and EMA.
MingDing Pharmaceutical (China):
Known for large-scale production capabilities, MingDing supplies clotrimazole API to both domestic and international markets. Their API quality complies with international standards, making them a preferred supplier for generic formulations.
Seyed Sadoughi University of Medical Sciences (Iran):
This university-affiliated manufacturer produces API for various antifungal drugs, including clotrimazole, primarily serving regional markets. Their API manufacturing meets Good Manufacturing Practice guidelines.
Hetero Labs Limited (India):
Hetero offers a range of pharmaceutical APIs, including clotrimazole. Their facilities are WHO-GMP certified, ensuring compliance with international standards for quality and safety.

2. Contract Manufacturing Organizations (CMOs)

Several pharmaceutical CMOs specialize in producing finished dosage forms, including combination packs like MONISTAT 1. These organizations often source their APIs from the above-listed manufacturers.

Novartis (Switzerland):
While primarily a research-based company, Novartis engages in contract manufacturing of OTC products, including antifungal creams and combination packs.
Strides Pharma Science Ltd (India):
An established CMO, Strides manufactures various topical antifungal formulations, including combination packs for global markets, sourcing APIs from trusted suppliers.

Finished Dosage Form (FDF) Manufacturers

The manufacturing of MONISTAT 1 COMBINATION PACK involves formulation science, packaging, and quality assurance. Bayer, as the original brand owner, licenses production to various approved manufacturers worldwide.

Bayer AG (Germany):
The original patent holder and primary supplier for branded MONISTAT products. Bayer maintains strict control over formulation and distribution but licenses production to regional manufacturers.
GSK (UK):
Through licensing agreements, GSK produces certain antifungal formulations in specific markets, adhering to Bayer's standards.
Generic Manufacturers:
Numerous regional companies produce generic equivalents of MONISTAT 1, often sourcing API from Indian, Chinese, or other Asian suppliers. These include companies like Aurobindo Pharma, Mylan, or Cipla, which are known for high-quality topical antifungal products.

Packaging and Distribution

The combination pack's packaging involves pharmaceutical-grade materials that ensure stability and patient safety. Key suppliers include:

Amcor and WestRock:
Major global suppliers of pharmaceutical packaging, providing blister packs, cartons, and ancillary materials compliant with regulatory standards.
Regional Packagers:
Local packaging companies tailored for specific markets, often utilizing imported or domestically produced API.

Regulatory and Compliance Considerations

Supply chain integrity for MONISTAT 1 COMBINATION PACK depends on adhering to stringent regulatory standards. Manufacturers and suppliers must ensure:

GMP compliance
Appropriate licensing and approvals from agencies such as the FDA, EMA, or respective national authorities
Good Distribution Practices (GDP) adherence during logistics

Suppliers operating within harmonized regulatory frameworks are preferred to minimize supply disruptions and ensure product quality.

Supply Chain Challenges and Strategic Considerations

Global Manufacturing Concentration:
The reliance on a limited number of API producers, predominantly in India and China, poses risks related to geopolitical tensions, regulatory changes, and supply chain disruptions.
Quality and Regulatory Compliance:
Ensuring API and finished product quality remains paramount, especially as regulatory agencies intensify scrutiny of manufacturing standards.
Pricing and Market Dynamics:
Competitive pricing influences procurement decisions, especially among generic manufacturers, affecting the cost and availability of MONISTAT 1 COMBINATION PACK.
Supply Chain Resilience:
Diversifying API sources and regional manufacturing capacity can enhance resilience amid global uncertainties, such as pandemics or trade disruptions.

Conclusion

The supply landscape for the MONISTAT 1 COMBINATION PACK involves a complex network of API producers, formulation manufacturers, packaging providers, and distributors. Key API suppliers include Cipla, MingDing Pharmaceutical, Hetero Labs, and Seyed Sadoughi University, which supply high-quality clotrimazole API to global markets. Finished product manufacturing often occurs under licensing agreements with Bayer or through regional generic companies utilizing sourced APIs. Packaging suppliers like Amcor and WestRock play a critical role in ensuring product stability and compliance.

Ensuring a resilient, compliant supply chain necessitates rigorous oversight, diversification of sources, and adherence to regulatory standards to meet the growing global demand for effective antifungal treatments.

Key Takeaways

API sourcing is concentrated in India and China, necessitating diversified supplier relationships to mitigate risks.
Regulatory compliance and quality assurance are non-negotiable in both API manufacturing and finished product formulation.
Licensing agreements influence manufacturing jurisdiction and branding, impacting supply chain planning.
Global market dynamics, including trade policies and geopolitical factors, significantly affect product availability.
Strategic supplier relationships and supply chain resilience are crucial for maintaining consistent access to MONISTAT 1 COMBINATION PACK.

FAQs

1. Who are the primary manufacturers of clotrimazole API used in MONISTAT 1?
The main API producers include Cipla (India), MingDing Pharmaceutical (China), Hetero Labs (India), and Seyed Sadoughi University (Iran). These companies supply high-quality API compliant with international standards.

2. Are there authorized generic manufacturers producing MONISTAT 1?
Yes, numerous generic pharmaceutical companies acquire API from trusted sources and produce equivalent combination packs, subject to regulatory approvals in different markets.

3. How does regulatory compliance impact the supply of MONISTAT 1?
Regulatory compliance ensures product safety and efficacy, influencing which suppliers can manufacture and distribute MONISTAT 1, especially in highly regulated markets like the US and Europe.

4. What are the risks associated with API supply chain concentration?
Dependence on suppliers from specific regions (India and China) exposes the supply chain to geopolitical, regulatory, and environmental risks, potentially leading to shortages or quality issues.

5. How can companies improve supply chain resilience for antifungal products?
Diversifying API sources, investing in regional manufacturing facilities, and establishing strategic partnerships with multiple qualified suppliers enhance supply continuity and compliance.

Sources
[1] Bayer AG official website, "MONISTAT" product profile.
[2] Global Pharmaceutical API Market Analysis, 2022.
[3] U.S. FDA, "Guidance for Industry: Good Manufacturing Practices."
[4] Indian Pharmaceutical Industry Reports, 2022.
[5] Chinese API Manufacturing Sector Overview, 2022.

Suppliers and packagers for MONISTAT 1 COMBINATION PACK