Bulk Pharmaceutical API Sources for MONISTAT 5

Bulk Pharmaceutical API Sources for MONISTAT 5

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M3512_SIGMA
TCI (Tokyo Chemical Industry)		M1769
Molport		MolPort-003-665-537
Amadis Chemical		A816380

Bulk Active Pharmaceutical Ingredient (API) Sources for MONISTAT 5

Last updated: August 9, 2025

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Introduction

Monistat 5 (active ingredient: miconazole nitrate) is an over-the-counter antifungal medication primarily used to treat yeast infections, including vulvovaginal candidiasis. The efficacy and safety of Monistat 5 hinge on its active pharmaceutical ingredient (API), miconazole nitrate. Ensuring a reliable supply chain of high-quality miconazole nitrate is critical for pharmaceutical companies manufacturing Monistat 5, impacting both product consistency and regulatory compliance.

This report provides an in-depth analysis of the global suppliers of bulk miconazole nitrate, focusing on their manufacturing capabilities, regulatory status, supply stability, and market positioning. Understanding these sources assists pharmaceutical manufacturers, procurement officers, and supply chain managers in strategic sourcing and risk mitigation.

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Regulatory and Quality Considerations

Before exploring top suppliers, it’s important to note that APIs must adhere to stringent quality standards established by regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national authorities. Suppliers must comply with current Good Manufacturing Practices (cGMP), demonstrate batch-to-batch consistency, and provide comprehensive analytical data.

Many reputable suppliers hold certifications including ISO 9001, ISO 13485 (for medical-grade APIs), and FDA Drug Master Files (DMF) submissions. These credentials underpin their credibility in supplying APIs suitable for pharmaceutical manufacturing.

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Major API Suppliers for Miconazole Nitrate

1. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

Overview: Zhejiang Hisun is a prominent Chinese pharmaceutical manufacturer known for producing a broad portfolio of APIs, including miconazole nitrate. The company has invested heavily in cGMP-certified manufacturing plants and holds multiple international certifications.

Capacity & Quality: Their facilities provide large-scale production capacity, with rigorous quality control measures ensuring compliance with global standards. They supply APIs to North America, Europe, and Asia.

Regulatory Status: Their products are often included in DMFs submitted to regulatory agencies, facilitating approval for finished dosage forms like Monistat 5.

2. Akums Drugs and Pharmaceuticals Ltd. (India)

Overview: Akums is a leading Indian API and formulation manufacturer, with a focus on antifungal and antimicrobial APIs. The company has achieved GMP compliance, multiple certifications, and supplies OEM (Original Equipment Manufacturer) APIs globally.

Capacity & Quality: Akums emphasizes high purity and consistent API quality, meeting international regulatory standards, including US FDA and European directives.

Supply Reliability: As a significant player in the Indian pharmaceutical landscape, Akums maintains strong supply chains, enabling sustained delivery of miconazole nitrate to global markets.

3. Zhejiang Chimei Pharmaceutical Co., Ltd. (China)

Overview: Zhejiang Chimei specializes in antifungal APIs, with notable expertise in miconazole nitrate production. Their facilities are cGMP-compliant and provide APIs for both generic and branded pharmaceutical applications.

Regulatory Standing: Their products often feature in global regulatory submissions, with the capacity to cater to high-volume orders.

Quality Assurance: They implement strict analytical testing, ensuring compliance with pharmacopeial standards such as USP and EP.

4. Beijing Yibai Pharmaceutical Co., Ltd. (China)

Overview: This Chinese manufacturer offers high-purity antifungal APIs, including miconazole nitrate. The firm emphasizes innovative manufacturing processes and quality control.

Market Reach: Yibai’s APIs are exported worldwide and often supplied with detailed analytical data to support regulatory filings.

Quality Certifications: The company maintains ISO certifications and has obtained approval from regulatory authorities for bulk API sales.

5. Erzkam Chemicals Pvt. Ltd. (India)

Overview: Erzkam is a specialist antifungal API manufacturer based in India, with a focus on miconazole nitrate. They leverage modern manufacturing facilities aligned with international standards.

Supply Chain & Quality: Their APIs are compliant with US Pharmacopeia (USP), European Pharmacopoeia (EP), and other relevant standards, ensuring suitability for pharmaceutical formulation.

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Emerging and Niche API Suppliers

Apart from the major players, several smaller manufacturers and contract manufacturers provide custom synthesis and supply of miconazole nitrate, often serving specific regional markets or working under contractual agreements. Their offerings might include negotiated API purity levels, packaging options, and tailored regulatory support.

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Supply Chain Dynamics and Risks

The sourcing of bulk miconazole nitrate involves navigating geopolitical factors, raw material availability, and manufacturing capacity constraints. Chinese and Indian manufacturers dominate the supply landscape due to their extensive infrastructure and cost advantages, but reliance on these regions can introduce geopolitical and regulatory risks.

Global disruptions, such as the COVID-19 pandemic, have illustrated vulnerabilities in supply chains, emphasizing the importance of diversified sourcing strategies. Pharmaceutical companies often mitigate risks by qualifying multiple suppliers, maintaining safety stock, and engaging in long-term contracts.

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Conclusion

The procurement of high-quality miconazole nitrate is crucial for the consistent production of Monistat 5. Leading suppliers like Zhejiang Hisun Pharmaceutical, Akums Drugs and Pharmaceuticals, Zhejiang Chimei Pharmaceutical, Beijing Yibai Pharmaceutical, and Erzkam Chemicals stand out due to their proven manufacturing capabilities, regulatory compliance, and global reach.

Strategic sourcing should prioritize suppliers with cGMP certification, robust quality assurance processes, and a track record of regulatory approvals. Diversification and close supplier engagement further reduce risks associated with supply interruptions.

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Key Takeaways

• Top Suppliers: Major players in miconazole nitrate supply include Zhejiang Hisun, Akums, Zhejiang Chimei, Beijing Yibai, and Erzkam, each offering high-quality APIs compliant with international standards.

• Regulatory Compliance: Validation of supplier GMP standards and analytical data submission (DMFs, API certificates) are essential for seamless regulatory approval.

• Supply Chain Strategy: Diversify sourcing across regions, establish long-term contracts, and build safety stocks to mitigate geopolitical and logistical risks.

• Quality Assurance: Regular audits, supplier qualification, and monitoring are critical to maintain consistent API quality.

• Future Trends: Increased demand for antifungal APIs and tightening regulatory standards will shape supply dynamics, necessitating proactive supplier relationship management.

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FAQs

1. Which regions dominate the supply of miconazole nitrate for pharmaceutical manufacturing?
China and India are the primary sources due to their extensive manufacturing infrastructure and cost advantages, accounting for the majority of global API production.

2. What are essential quality criteria when sourcing miconazole nitrate?
Suppliers must demonstrate compliance with cGMP, provide batch analytical data aligned with USP, EP, or other pharmacopeias, and hold relevant certifications like ISO 9001.

3. How can pharmaceutical companies mitigate supply chain risks for API sourcing?
Diversify suppliers across regions, establish long-term supply agreements, maintain safety stock levels, and conduct regular audits to ensure quality and supply stability.

4. Are there any regulatory hurdles associated with importing miconazole nitrate APIs?
Yes. Regulatory agencies require detailed documentation, including API certificates, analytical reports, and compliance with local regulatory standards, which necessitate proactive communication with authorities.

5. What future developments can influence API sourcing strategies for antifungals like miconazole nitrate?
Growing demand, stricter quality standards, geopolitical considerations, and sustainability initiatives may impact sourcing strategies, emphasizing the need for resilient and diversified supply chains.

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References

[1] U.S. Pharmacopoeia (USP). Monographs and quality standards for miconazole nitrate.
[2] European Pharmacopoeia (EP). Monographs and pharmacopeial standards.
[3] Industry reports on antifungal API suppliers and market analysis.
[4] Company disclosures, certifications, and DMFs from verified API manufacturers.