Bulk Pharmaceutical API Sources for AZOLID

Bulk Pharmaceutical API Sources for AZOLID

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		P8386_SIGMA
Vitas-M Laboratory		STK388348
TCI (Tokyo Chemical Industry)		P1686

Bulk Active Pharmaceutical Ingredient (API) Sources for Azolid

Last updated: July 29, 2025

Introduction

Azolid, a pharmaceutical compound utilized primarily as an antifungal agent, has garnered significant attention due to its efficacy in treating various fungal infections. As pharmaceutical manufacturers seek reliable sources for bulk Active Pharmaceutical Ingredients (APIs), understanding the landscape of suppliers and the nuances of sourcing Azolid becomes paramount. This report comprehensively details the global API landscape for Azolid, highlighting primary manufacturing regions, key suppliers, regulatory considerations, and market trends. Such insights enable stakeholders to make strategic procurement decisions, ensure compliance, and maintain supply chain stability.

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Overview of Azolid and Its Pharmaceutical Significance

Azolid belongs to the azole class of antifungal agents, characterized by their inhibition of ergosterol synthesis in fungal cell membranes. The compound’s pharmacological profile makes it suitable for treating systemic and topical fungal infections, including candidiasis and dermatophytoses. Its widespread application necessitates a consistent, high-quality supply of APIs compliant with international standards such as USP, EP, and JP [1].

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Global API Manufacturing Landscape for Azolid

1. Asia-Pacific Dominance

The Asia-Pacific region remains the epicenter for API manufacturing, driven by abundant raw materials, lower production costs, and established expertise. Countries like China, India, and South Korea dominate API production globally, accounting for approximately 70-80% of the world’s API supply chain [2].

• China: Hosts numerous GMP-certified API manufacturers specializing in complex supplies, including antifungals like Azolid. Major Chinese API producers often serve both domestic and export markets, complying with international quality standards.

• India: Known for its robust generic pharmaceutical industry, Indian API manufacturers produce Azolid APIs meeting global regulatory requirements. India’s focus on cost-effective manufacturing and quality assurance positions it as a key supplier.

2. European and North American Markets

While smaller in volume, European and North American suppliers focus on high-value, highly regulated markets. They emphasize stringent compliance with regulatory standards, quality control, and traceability.

• Europe: Manufacturers often cater to the European Union’s strict pharmacopoeial standards, with facilities in Germany, Switzerland, and France. These suppliers typically command premium pricing but offer high assurance of quality.

• North America: Companies in the US and Canada primarily focus on APIs for domestic use or export under strict FDA regulations, emphasizing Good Manufacturing Practices (GMP).

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Leading API Suppliers for Azolid

Several prominent suppliers worldwide supply bulk Azolid API, distinguished by their manufacturing scale, regulatory compliance, and certification status.

1. Zhejiang Medicines Co., Ltd. (China)

Zhejiang Medicines is a well-established Chinese API manufacturer with GMP certification. They produce Azolid APIs for global markets and maintain rigorous quality standards aligned with international pharmacopoeias [3].

2. Aurobindo Pharma Ltd. (India)

Aurobindo is one of India’s largest API producers, operating multiple manufacturing facilities with WHO-GMP and ISO certifications. Their Azolid API offerings meet global regulatory standards and are supplied to both generic and branded pharmaceutical companies [4].

3. Hovione (Portugal)

Hovione specializes in complex APIs and intermediates, with a focus on high-quality production. Their manufacturing processes often incorporate advanced techniques to ensure API purity and consistency, making them a notable supplier for Azolid in regulated markets [5].

4. Sandoz (Switzerland)

As a division of Novartis, Sandoz supplies high-quality APIs with impeccable regulatory compliance, primarily serving European and North American markets. While more known for innovative compounds, they maintain a portfolio of antifungal APIs, including Azolid derivatives [6].

5. Lupin Limited (India)

Lupin, another major Indian API manufacturer, offers competitive pricing for Azolid APIs, backed by GMP certification and global quality assurance programs. Their extensive supply chain capabilities support large-volume orders [7].

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Regulatory Considerations in Sourcing Azolid API

• Quality Certifications: Suppliers must adhere to GMP, ISO, and other relevant standards to ensure API consistency and safety.
• Regulatory Approvals: Suppliers should possess certifications and registrations with regulatory agencies such as the FDA, EMA, or PMDA, depending on target markets.
• Documentation and Traceability: Comprehensive batch documentation, stability data, and manufacturing process transparency are essential for regulatory compliance.
• Environmental and Ethical Standards: Suppliers complying with environmental regulations and ethical labor practices reduce risk of supply disruptions or reputation damage.

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Market Trends and Future Outlook

• Growing Demand: The increasing prevalence of fungal infections, coupled with the expansion of antifungal treatment protocols, is expected to sustain demand for Azolid APIs.
• Vertical Integration: Major pharmaceutical companies increasingly invest in in-house API manufacturing or long-term supplier agreements to secure supply stability.
• Regulatory Stringency: Enhanced requirements for API purity, traceability, and environmental compliance are raising barriers to entry but ensuring higher quality standards across the supply chain.
• Emerging Suppliers: New entrants from Southeast Asia and Eastern Europe are emerging, driven by cost advantages and regional trade agreements, potentially diversifying the API sourcing landscape.

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Sourcing Strategy Recommendations

• Evaluate Supplier Capabilities: Prioritize suppliers with proven regulatory compliance, GMP certifications, and quality control infrastructure.
• Assess Supply Chain Stability: Consider providers with diversified manufacturing sites and proven track records of on-time delivery.
• Negotiate Long-term Agreements: Secure favorable pricing, volume commitments, and quality assurance clauses to mitigate market and supply risks.
• Perform Due Diligence: Conduct rigorous audits and review documentation to verify regulatory compliance and manufacturing practices.

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Key Takeaways

• The primary sources of bulk Azolid API are concentrated in China and India, with European and North American suppliers focusing on high-regulatory standard markets.
• Leading manufacturers such as Zhejiang Medicines, Aurobindo Pharma, Hovione, Sandoz, and Lupin offer reliable API supply, with varying price and quality profiles.
• Regulatory compliance (GMP, ISO) and documentation are non-negotiable criteria for procurement, especially for markets with strict standards.
• Market dynamics favor diversified sourcing strategies, emphasizing quality assurance, supply chain resilience, and cost optimization.
• Growing regulatory stringency and demand signals suggest a stable outlook with opportunities for strategic partnership development.

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FAQs

1. How can I verify the regulatory compliance of an API supplier for Azolid?
Verify certifications such as GMP certification, product compliance documentation, and regulatory approvals from agencies like the FDA or EMA. Audits and third-party quality assessments further validate compliance.

2. What are the typical lead times for sourcing Azolid API in bulk?
Lead times generally range from 8 to 16 weeks, depending on supplier capacity, order volume, and regulatory clearance processes.

3. Are there any regional restrictions on importing Azolid APIs?
Import restrictions depend on local regulations. Ensure supplier documentation and certificates align with the importing country’s requirements, and conduct customs compliance checks.

4. How does raw material sourcing impact Azolid API quality?
Raw material sourcing directly impacts API purity, stability, and efficacy. Reputable manufacturers often integrate upstream raw material control and validation processes to ensure consistent API quality.

5. What pricing trends are observed in the Azolid API market?
Pricing remains competitive, influenced by raw material costs, manufacturing scale, regulatory compliance, and global demand. Economies of scale and long-term supply agreements tend to reduce unit costs.

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References

[1] International Pharmacopoeia, WHO. (2022). Active Pharmaceutical Ingredients: Overview and Standards.
[2] Statista. (2023). Global API Manufacturing Share by Region.
[3] Zhejiang Medicines Co., Ltd. Website. (2023). Product Portfolio & Certifications.
[4] Aurobindo Pharma Ltd. Annual Report. (2022).
[5] Hovione Official Site. (2023). API Production Capabilities.
[6] Sandoz. (2022). API Portfolio & Quality Standards.
[7] Lupin Limited. Annual Report. (2022).