Bulk Pharmaceutical API Sources for oxiconazole nitrate

Bulk Pharmaceutical API Sources for oxiconazole nitrate

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-666-639
Amadis Chemical		A834676
Finetech Industry Limited		FT-0630744
Key Organics/BIONET		KS-5288
AKos Consulting & Solutions		AKOS016339564
BOC Sciences		64211-46-7
TargetMol		T1290

Bulk Active Pharmaceutical Ingredient (API) Sources for Oxiconazole Nitrate

Last updated: August 13, 2025

Introduction

Oxiconazole nitrate is an imidazole antifungal agent widely used to treat fungal infections of the skin and mucous membranes. Recognized for its safety profile and efficacy, oxiconazole nitrate's manufacturing and supply chain hinge on reliable sources of bulk Active Pharmaceutical Ingredient (API). As the demand for topical antifungal treatments rises, understanding the geopolitical landscape and supply chain dynamics for oxiconazole nitrate API becomes critical for pharmaceutical companies and stakeholders seeking quality, cost-effective, and compliant suppliers.

Overview of Oxiconazole Nitrate API

Oxiconazole nitrate’s chemical name is 1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl)methylethanol nitrate. Its molecular weight is approximately 350.2 g/mol, and it exhibits high potency as a broad-spectrum antifungal agent. The API is produced via complex synthetic pathways involving chlorination, imidazole ring formation, and nitrate salt stabilization, necessitating high purity standards aligned with Good Manufacturing Practices (GMP).

Manufacturers and distributors of oxiconazole nitrate API typically operate within regions with established chemical manufacturing capabilities, including India, China, and certain European countries.

Major Sources of Oxiconazole Nitrate API

1. Indian API Manufacturers

India has emerged as a prominent hub for the manufacture of generic APIs, including antifungal agents such as oxiconazole nitrate. The Indian pharmaceutical sector benefits from a robust domestic market, cost-efficient manufacturing, and compliance with international regulatory standards.

Leading Indian Stakeholders:

• Lupin Limited: One of India’s largest API manufacturers with a diversified portfolio, including antifungal APIs. Lupin invests heavily in GMP-compliant manufacturing facilities, adhering to global standards (USFDA, EMA).

• Aurobindo Pharma: Known for its extensive API production facilities, Aurobindo supplies APIs globally, with a focus on antifungal agents. Their manufacturing plants are approved by major regulatory agencies.

• Sun Pharmaceutical Industries: While primarily known for formulations, Sun Pharma also produces APIs, including antifungal compounds, with facilities adhering to international GMP standards.

• Emcure Pharmaceuticals: Focuses on generic APIs with strong export capabilities, including antifungal raw materials. Their manufacturing quality aligns with WHO and USFDA standards.

Advantages of Indian API sources:

• Cost competitiveness due to lower manufacturing costs.
• Extensive expertise in complex chemical syntheses.
• Regulatory approvals and compliance with international standards.

2. Chinese API Manufacturers

China continues to be a key player in the global API supply chain, including antifungal APIs such as oxiconazole nitrate.

Major Chinese API Suppliers:

• Hubei Y R Pharmaceutical Co., Ltd.: Specializes in antifungal APIs, with GMP-certified facilities and a reputation for consistent supply.

• Qingdao Zhongjian Pharmaceutical Co., Ltd.: Offers bulk quantities of active pharmaceutical ingredients, including imidazole derivatives.

• Shandong Xinhua Pharmaceutical: Recognized for its scale of production and compliance with international standards.

Key considerations:

• Chinese API suppliers often provide competitive pricing.
• Increasing regulatory scrutiny and quality assurance have improved, but due diligence remains necessary.
• Regulatory recognition varies, with some suppliers seeking international accreditations like USFDA, EMA, or ISO.

3. European and Other Regulatory-Approved API Manufacturers

While fewer in number compared to India and China, certain European firms provide APIs manufactured under strict GMP standards, often serving regulated markets such as the EU and US.

• EU-GMP Certified Manufacturers: Limited but vital, these suppliers cater mainly to high-quality markets, often with proprietary manufacturing processes.

• United States: Due to strict regulatory standards, U.S.-based API manufacturers are less common for bulk antifungal APIs but participate in API synthesis for specialty formulations.

4. Contract Manufacturing Organizations (CMOs)

Pharmaceutical companies increasingly rely on CMOs for API production to ensure quality, scalability, and cost-efficiency.

• Premier Research and Lonza are examples of CMOs capable of producing high-quality oxiconazole nitrate APIs under cGMP conditions, adaptable for large-scale production.

• Familiarity with complex synthesis routes makes CMOs valuable partners for niche APIs like oxiconazole nitrate.

Factors Influencing API Source Selection

Regulatory Compliance

Suppliers with validated GMP certifications, such as USFDA, EMA, or WHO, are preferred for APIs intended for markets with stringent regulations.

Quality Standards

High pharmaceutical purity (>99%) with low levels of impurities (e.g., residual solvents, heavy metals) is essential. Certificates of Analysis (CoA) and batch documentation play critical roles in supplier evaluation.

Cost and Lead Time

Global supply chains balance cost against reliability. Indian and Chinese sources generally offer competitive pricing, but logistical considerations—such as shipping times and import tariffs—impact procurement strategies.

Supply Security and Scalability

Long-term partnerships with suppliers capable of scaled production mitigate risks associated with shortages, regulatory delays, and quality issues.

Regulatory Considerations and Global Market Dynamics

The global antifungal API market faces evolving regulations, especially regarding quality standards and supply chain transparency. Indian and Chinese manufacturers are increasingly pursuing formal certifications to access regulated markets, which influences sourcing decisions. Additionally, recent geopolitical shifts and trade policies impact import/export dynamics for APIs, emphasizing the need for diversified sourcing strategies.

Challenges in Sourcing Oxiconazole Nitrate API

• Regulatory Barriers: Not all suppliers hold GMP certifications recognized globally, limiting market access.
• Quality Variability: Variations in purity and impurity profiles necessitate rigorous vetting.
• Intellectual Property (IP) and Patent Considerations: While oxiconazole nitrate patents have expired in many jurisdictions, manufacturing processes may still be proprietary, affecting licensing options.
• Supply Chain Risks: Disruptions in geopolitical relations, pandemics, or economic instability can impact API availability.

Conclusion

A reliable source of oxiconazole nitrate API combines rigorous quality standards, regulatory compliance, cost-effectiveness, and supply security. Indian and Chinese manufacturers dominate the landscape, with European firms providing high-quality certifications for regulated markets. Strategic sourcing, involving diversified suppliers, ensures continuity, quality, and compliance in the global supply chain.

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Key Takeaways

• Indian API manufacturers, such as Lupin and Aurobindo, are leading suppliers, offering cost-effective and GMP-compliant oxiconazole nitrate APIs.
• Chinese manufacturers provide competitive pricing and large-scale production but require thorough regulatory vetting.
• European providers offer premium, regulation-ready APIs suited for high-standard markets.
• Contract manufacturing organizations can be strategic partners for scalable and compliant API production.
• Due diligence on quality certifications, supply reliability, and regulatory recognition remains critical for global procurement success.

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FAQs

1. What are the primary regions supplying bulk oxiconazole nitrate API globally?
India and China dominate as primary sources, with European suppliers providing high-quality options for regulated markets.

2. How important is GMP certification when sourcing oxiconazole nitrate API?
GMP certification ensures the API meets quality, purity, and safety standards necessary for regulatory approval and patient safety.

3. Are there alternative sources of oxiconazole nitrate API outside Asia and Europe?
Limited; most producers are based in Asia (India, China) and select European countries, with few manufacturers elsewhere due to synthesis complexity.

4. What are the key considerations when choosing an API supplier?
Regulatory compliance, quality standards, cost, lead times, supply security, and reputation are critical factors.

5. How do geopolitical factors influence sourcing decisions for oxiconazole nitrate API?
Trade policies, tariffs, and diplomatic relations can impact import/export clarity, pricing, and supply chain stability.

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Sources

1. [1] “Global API Market Trends,” Pharmaceutical Technology, 2022.
2. [2] U.S. Food and Drug Administration (FDA) – GMP requirements documentation.
3. [3] Indian Pharmaceutical Industry Reports, 2021.
4. [4] Chinese API Manufacturers Directory, 2022.
5. [5] European Medicines Agency (EMA) Standards for Pharmaceutical Manufacturing, 2023.