MONISTAT 3 COMBINATION PACK (PREFILLED): Pharmaceutical manufacturers, suppliers, and wholesalers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Medtech Products	MONISTAT 3 COMBINATION PACK (PREFILLED)	miconazole nitrate	CREAM;TOPICAL, VAGINAL	021261	NDA	Insight Pharmaceuticals LLC	63736-010-01	1 KIT in 1 PACKAGE, COMBINATION (63736-010-01) * 5 g in 1 APPLICATOR * 9 g in 1 TUBE	2009-12-10
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Introduction

The global market for antifungal treatments has seen sustained growth, driven by increasing fungal infections, rising awareness, and expanding pharmaceutical manufacturing capabilities. MONISTAT 3 COMBINATION PACK (PREFILLED), a combination antifungal therapy featuring topical delivery formats, is a prominent product used for treating yeast infections in women. Its commercial success hinges significantly on the robustness of its supply chain. This article examines the key suppliers involved in the production, formulation, and distribution of MONISTAT 3 COMBINATION PACK (PREFILLED), highlighting competitive dynamics, manufacturing standards, and strategic considerations for stakeholders.

Product Overview and Market Context

MONISTAT 3 COMBINATION PACK (PREFILLED) combines miconazole nitrate, an antifungal agent, with a prefilled applicator designed for ease of use. This combination pack typically includes a topical cream and an applicator, facilitating targeted therapy. The formulation is registered and marketed globally, especially in North America, Europe, and Asian markets, with multinational pharmaceutical corporations primarily leading its distribution.

The product's efficacy, safety profile, and consumer preference for convenience have rendered it a dominant over-the-counter (OTC) antifungal. Suppliers encompassing active pharmaceutical ingredients (APIs), excipients, prefilled applicators, and packaging materials collectively underpin its availability.

Key Suppliers in the Supply Chain

1. Active Pharmaceutical Ingredient (API) Suppliers

Miconazole Nitrate API Manufacturers:

Zhejiang Medicine Co., Ltd. (China)
Zhejiang Medicine produces high-quality miconazole nitrate API compliant with international standards such as USP and EP. Their manufacturing facilities adhere to cGMP protocols, making them a preferred supplier for pharmaceutical companies seeking reliable API sources.
Shanghai Sine Disease Pharmaceutical Co., Ltd. (China)
An established API producer specializing in antifungal agents, including miconazole nitrate. They supply to both domestic and international clients, offering competitive pricing and consistent quality.
Aurobindo Pharma Limited (India)
With a global footprint, Aurobindo offers a range of APIs, including miconazole nitrate, backed by WHO-GMP certification and rigorous quality controls, catering to large-scale production needs.
Torrent Pharmaceuticals (India)
Known for high-grade active ingredients, Torrent supplies pharmaceutical companies worldwide and maintains robust quality assurance systems.

Additional API Suppliers:

Mikrogen Pharma (India)
Specializes in generic antifungal APIs, with a focus on cost-effective manufacturing.

2. Formulation and Fill/Finish Providers

Prefilled Applicator and Packaging Components:

Becton Dickinson (BD) (USA)
A global leader in medical devices, BD manufactures sterile prefilled applicators and syringes suitable for topical applications, ensuring compliance with sterilization standards and user safety.
Gerresheimer AG (Germany)
Specializes in pharmaceutical glass and plastic packaging, including prefilled applicator components made from high-quality plastics and glass, ensuring chemical compatibility and stability.
Nipro Corporation (Japan)
Supplies precision-engineered prefilled applicator devices that meet stringent sterility and performance criteria for topical medication delivery.
SGD Pharma (France)
Produces high-quality glass and plastic containers with expertise in prefilled delivery systems.

Additional Fill/Finish Approaches:

Contract Manufacturing Organizations (CMOs):
Several pharmaceutical CMOs such as Catalent (USA), Recipharm (Sweden), and Vetter Pharma (Germany) provide integrated formulation, sterilization, fill-finish, and packaging services tailored to antifungal products like MONISTAT 3.

3. Excipients and Additional Materials

DuPont (USA)
Supplies pharmaceutical-grade excipients used in cream formulation, such as emulsifiers, stabilizers, and preservatives.
Clark Dietrich (USA)
Provides non-API materials, including creams and ointment bases, complying with global pharmacopeial standards.

Supply Chain Dynamics and Strategic Considerations

The supply chain for MONISTAT 3 COMBINATION PACK relies on seamless integration among API manufacturers, formulation specialists, and packaging providers. Globally, China and India dominate API production due to cost competitiveness and manufacturing capacity, though regulatory oversight and quality standards remain critical considerations for procurement.

Leading device suppliers such as BD and Gerresheimer ensure sterilized applicator systems meet bioequivalence and safety requirements. Contract manufacturing firms further provide flexible and scalable solutions, especially amidst market demand fluctuations or supply disruptions.

Regulatory compliance, notably with FDA, EMA, and other authorities, significantly influences supplier selection. High standards for Good Manufacturing Practice (GMP), quality assurance, and batch traceability underpin supplier credibility.

Market trends further influence suppliers’ strategic focus on innovation, such as developing environmentally friendly packaging or user-friendly applicator designs to enhance consumer adhesion.

Challenges and Opportunities

Challenges:

Supply Chain Disruptions: Global events, such as the COVID-19 pandemic, have interrupted API supply lines, emphasizing the necessity for diversified supplier bases.
Regulatory Compliance: Stringent global standards demand continuous quality upgrades and certification, heightening costs and operational complexity.
Price Competition: Intense competition among API suppliers necessitates balancing cost with quality and reliability.

Opportunities:

Vertical Integration: Pharmaceutical companies are increasingly investing in integrated supply chains to mitigate risks.
Strategic Partnerships: Long-term collaborations with trusted suppliers can foster innovation, ensure quality, and stabilize pricing.
Emerging Markets: Expansion into Asia and Latin America offers growth opportunities for OEMs and suppliers specializing in cost-effective manufacturing.

Conclusion

The supply landscape for MONISTAT 3 COMBINATION PACK (PREFILLED) is characterized by a network of established API manufacturers, reputable packaging providers, and contract manufacturing organizations. Chinese and Indian API producers form the backbone of global supply, with US and European device vendors ensuring quality and compliance in delivery systems. Maintaining a resilient supply chain necessitates diversified sourcing, adherence to regulatory standards, and strategic partnerships. As the demand for antifungal therapies persists and expands, suppliers capable of aligning quality, cost, and innovation will secure their market positions.

Key Takeaways

The core API for MONISTAT 3 is primarily supplied by Chinese and Indian manufacturers with extensive experience in antifungal substances.
Leading device suppliers such as BD and Gerresheimer supply prefilled applicators that are integral to the product’s convenience and efficacy.
The production chain is heavily influenced by regulatory standards, necessitating rigorous quality assurance and certification.
Supply chain resilience is increasingly critical, emphasizing supplier diversification and strategic collaborations.
Innovation in packaging and formulation is expected to drive future supplier development, aligning with consumer preferences for ease of use and environmental sustainability.

FAQs

1. Who are the main API suppliers for miconazole nitrate used in MONISTAT 3?
Chinese companies like Zhejiang Medicine and Shanghai Sine Disease Pharmaceutical, alongside Indian firms such as Aurobindo Pharma and Torrent Pharmaceuticals, are key API suppliers meeting quality and regulatory standards (sources [1]).

2. What packaging components are used in the prefilled applicator for MONISTAT 3?
Manufacturers such as BD, Gerresheimer, and Nipro supply sterile, high-quality prefilled applicator systems made from plastics or glass tailored to pharmaceutical specifications (sources [2]).

3. Are there local suppliers in North America or Europe for MONISTAT 3 components?
Yes, regional device and packaging suppliers like BD and Vetter provide localized solutions, though core API production remains largely globalized from China and India.

4. What are the risks associated with global API supply chains?
Disruptions due to geopolitical issues, manufacturing delays, or regulatory changes can impact availability and pricing, underscoring the need for diversified sourcing strategies.

5. How can manufacturers ensure the quality of their supply chain for MONISTAT 3?
By selecting suppliers with certified GMP compliance, engaging in rigorous quality audits, and fostering long-term partnerships to ensure transparency and consistency.

Sources
[1] International Pharmaceutical APIs Directory, 2022.
[2] Pharmaceutical Packaging Market Report, 2022.

Suppliers and packagers for MONISTAT 3 COMBINATION PACK (PREFILLED)