Bulk Pharmaceutical API Sources for FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		F8929_SIGMA
Ambinter		KS-1059
Hangzhou Trylead Chemical Technology		TL8005609
NovoSeek		3365
ZINC		ZINC00004009

Bulk Active Pharmaceutical Ingredient (API) Sources for Fluconazole in Dextrose 5% in Plastic Container

Last updated: August 1, 2025

Introduction

Fluconazole, a broad-spectrum antifungal agent, is critically used in managing invasive fungal infections. When formulated as a pharmaceutical product, it is often supplied in bulk as an Active Pharmaceutical Ingredient (API) for manufacturing. Particularly, fluconazole in dextrose 5% in plastic containers (commonly known as D5W) is widely utilized in intravenous (IV) therapies owing to its stability and compatibility with IV delivery systems. Sourcing high-quality API is fundamental for pharmaceutical manufacturers seeking reliable, compliant suppliers capable of consistent quality, regulatory adherence, and supply continuity.

This report details the leading sources of bulk fluconazole API suitable for compounding into Dextrose 5% solutions in plastic containers, examines their capabilities, and highlights key considerations for procurement.

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Overview of Fluconazole API Manufacturing

Fluconazole API manufacturing requires advanced synthetic chemistry and stringent quality controls owing to its complex structure and potent antifungal activity. Global API manufacturing is concentrated among a handful of regions, notably India, China, and Europe, which host established pharmaceutical chemical producers equipped with integrated manufacturing and testing facilities.

Manufacturers adhere to international Good Manufacturing Practices (GMP) standards, including those mandated by U.S. FDA, EMA, or local regulatory authorities. The selection of suppliers must prioritize compliance, batch consistency, purity levels (often >99%), and documentation transparency.

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Major Sources of Fluconazole API

1. Indian Manufacturers

India's pharmaceutical sector is prominent in global API supply, notably for antifungal agents like fluconazole. Several Indian companies are recognized for their high-quality APIs tailored for intravenous formulations.

• Sun Pharmaceutical Industries Ltd.

  • Capabilities: Global GMP-compliant manufacturing, extensive quality control, and export volumes.
  • Certifications: USFDA, TGA, EUGMP.
  • Key strengths: Reliable supply chain and regulatory support.

• Cipla Limited

  • Capabilities: Produces bulk fluconazole API with high purity suitable for parenteral formulations.
  • Certifications: USFDA, MHRA, EDQM.
  • Capacity: Large production volumes with adherence to cGMP.

• Divi's Laboratories

  • Capabilities: Focused on complex APIs, with consistent high-quality fluconazole API.
  • Certifications: USFDA, ISO 9001/14001.
  • Specialization: High purity levels and stable supply.

2. Chinese API Manufacturers

China remains a significant player for bulk APIs, including fluconazole, offering competitive pricing and flexible manufacturing.

• Zhejiang Huahai Pharmaceuticals

  • Capabilities: GMP-certified, large-scale API production with international standards.
  • Certifications: CN-GMP, USFDA inspection approvals.
  • Strengths: Cost-effective, well-established supply chain.

• North China Pharmaceutical Group (NCPC)

  • Capabilities: Produces a range of antifungal APIs with stringent quality controls.
  • Certifications: China GMP, CE, and some USFDA approvals.
  • Key features: Flexible batch sizes, rapid delivery.

• Harbin Pharmaceutical Group Co. Ltd.

  • Capabilities: Qualified for international markets, consistent API quality, and competitive pricing.

3. European API Manufacturers

European producers offer high-quality APIs, often with stringent regulatory oversight and extensive documentation.

• Lek (part of Sandoz)

  • Capabilities: European pharmaceutical-grade API manufacturing, adherence to EMA standards.
  • Certifications: EMA, ISO 9001.
  • Market Position: Known for high purity standards and reliable supply.

• Polpharma

  • Capabilities: Established supplier of generic API, including antifungals.
  • Certifications: EU-GMP, ISO certified.
  • Benefits: Consistent quality and regulatory robustness.

4. Contract Manufacturing Organizations (CMOs)

Multiple contract manufacturers operate globally, offering custom synthesis and supply of fluconazole API.

• BASF

  • Capabilities: Custom synthesis with high regulatory standards, global logistics.
  • Certifications: GMP, ISO.

• Lonza

  • Capabilities: Contract API manufacturing with tailored batch sizes and regulatory compliance.

• Aurobindo Pharma

  • Capabilities: Wide portfolio of APIs, including antifungals, with substantial manufacturing capacity.

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Critical Considerations for API Sourcing

Quality and Compliance

Suppliers must demonstrate compliance with cGMP standards, possess regulatory approvals (e.g., USFDA, EU-GMP), and provide comprehensive documentation, including Certificates of Analysis (CoA), Batch Production Records, and stability data.

Purity and Specifications

High purity (>99%), low impurity profiles, and secure control over residual solvents and heavy metals are vital, especially given the formulation into IV Dextrose 5%. Suppliers should provide certificates confirming these specifications.

Regulatory Compatibility

For formulations intended for global markets, API suppliers must ensure APIs conform to regional regulatory standards, facilitating easier market entry and approval.

Supply Chain Reliability

Given the critical need for uninterrupted medication availability, manufacturers should evaluate supplier capacity, production flexibility, lead times, and contingency planning.

Cost and Lead Time

While quality remains paramount, competitive pricing and scalable lead times are crucial for procurement planning, especially amid global supply chain disruptions.

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Market Dynamics and Trends

The antifungal API market faces ongoing challenges, such as regulatory scrutiny over manufacturing practices and geopolitical influences affecting supply chains. Indian and Chinese API producers dominate the market due to cost-efficiency and scaling capabilities, yet European suppliers offer benefits in regulatory familiarity and perceived higher quality standards.

Recently, increased quality assurance measures and regional regulatory stipulations underscore the importance of supplier audits and validated quality management systems. Innovative manufacturing processes, such as continuous synthesis and increased automation, enhance API quality and supply robustness[1].

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Conclusion

Securing a reliable source of bulk fluconazole API for formulation into Dextrose 5% requires strategic evaluation of supplier capabilities, compliance, and supply chain resilience. Indian and Chinese manufacturers currently lead the market, offering a balance of quality, cost, and capacity, while European suppliers provide high-quality alternatives aligned with stringent regulatory environments.

For pharmaceutical companies targeting international markets, establishing long-term partnerships with certified suppliers that demonstrate consistency, regulatory compliance, and robust quality controls is essential for ensuring uninterrupted production of intravenous antifungal therapies.

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Key Takeaways

• Indian and Chinese API manufacturers dominate bulk fluconazole supplies due to cost-effectiveness and high production capacity.
• European suppliers, such as Sandoz and Polpharma, offer high-quality APIs with advanced regulatory compliance.
• Key considerations include API purity, GMP certification, regulatory approvals, and supply chain reliability.
• Contract manufacturing organizations provide flexible, tailored solutions but require rigorous qualification.
• Continuous market vigilance and supplier audits are essential amid dynamic regulatory and geopolitical landscapes.

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FAQs

1. What are the primary regions supplying bulk fluconazole API?
India and China lead the market, with European suppliers also providing high-quality options.

2. How should a company evaluate API suppliers for pharmaceutical manufacturing?
Assess GMP compliance, regulatory approvals, purity profiles, documentation, supply capacity, and historical reliability.

3. Are there differences in API quality standards between suppliers from different regions?
Yes; European suppliers generally adhere to more stringent regulatory standards, though leading Indian and Chinese manufacturers also meet global cGMP standards.

4. What are the critical specifications for fluconazole API intended for IV formulations?
Purity (>99%), low residual solvents, minimal impurities, consistent potency, and compliance with pharmacopeial standards.

5. How can pharmaceutical companies mitigate supply chain risks for critical APIs?
Diversify suppliers, establish quality agreements, conduct regular audits, and maintain strategic inventory buffers.

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References

[1] “Global API Market Trends,” Pharmaceutical Technology, 2022.