Bulk Pharmaceutical API Sources for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

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

Bulk Active Pharmaceutical Ingredient (API) Sources for Fluconazole in Sodium Chloride 0.9% in Plastic Container

Last updated: August 2, 2025

Introduction

Fluconazole, a triazole antifungal agent, commands a significant role in managing invasive and superficial fungal infections. Its broad spectrum efficacy, favorable safety profile, and availability in various formulations—including intravenous (IV) solutions such as fluconazole in sodium chloride (NaCl) 0.9%—drive global demand. Ensuring a reliable raw material supply chain for bulk active pharmaceutical ingredients (APIs) is crucial for pharmaceutical manufacturers producing fluconazole in sterile, ready-to-use plastic containers.

This review aims to delineate the primary sources of bulk fluconazole API suitable for formulation into NaCl 0.9% infusion solutions, encapsulating their manufacturing capabilities, global presence, regulatory standing, and quality compliances.

Overview of Fluconazole API Manufacturing

Globally, the synthesis of fluconazole API adheres to stringent quality standards defined by regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and increasingly strict Good Manufacturing Practices (GMP). The raw API is generally supplied in fine powders or crystalline form, compatible with large-scale sterile infusion preparations.

Manufacturers leverage advanced chemical synthesis pathways, predominantly involving the fluorination of heterocyclic intermediates, to achieve high-purity APIs. The final APIs are tested for purity (>99%), residual solvents, polymorphs, and microbial contamination before licensing for pharmaceutical use.

Key API Sourcing Options

1. Established Multinational Pharmaceutical API Suppliers

• Fuso Pharmaceutical Industries, Ltd. (Japan)
  Fuso has a long-standing reputation for producing high-quality fluconazole APIs. Their manufacturing facilities employ advanced synthesis techniques, ensuring batch-to-batch consistency and adherence to cGMP standards.[1] Their API is widely supplied globally, with certifications compliant with major regulatory authorities.

• Hetero Labs Limited (India)
  Hetero is a prominent Indian pharmaceutical company with extensive experience in antifungal APIs. Their fluconazole API production meets international standards, with supplies tailored for both oral and intravenous formulations.[2]

• Ming Kook Enterprise Co., Ltd. (Taiwan)
  Specializing in generic APIs, Ming Kook offers high-purity fluconazole APIs suitable for sterile infusion preparations, complying with USP and EP quality standards.[3] Their manufacturing facilities are GMP-certified and have strong export presence.

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
  Hisun produces a variety of APIs, including fluconazole, with robust quality assurance systems. Their API meets the specifications required for infusion solutions, with extensive regulatory submissions in Asia and globally.[4]

2. Regional Suppliers with Growing Presence

• Sandoz (Germany/Global)
  As a division of Novartis, Sandoz supplies sterile APIs and finished formulations. Their API manufacturing platforms are GMP-compliant, often serving as a trusted source for sterile injectables.

• Hindustan Antibiotics Ltd. (India)
  A government-led manufacturing entity with capabilities in producing antifungal APIs, including fluconazole, primarily catering to the domestic market but also exporting to select regions.[5] Their APIs comply with major pharmacopeial standards.

• Sun Pharmaceutical Industries Ltd. (India)
  Sun Pharma has integrated API manufacturing for antifungals that conform to global standards, with supply chains supporting sterile formulations.[6]

3. Contract Manufacturing Organizations (CMOs)

• Dr. Reddy’s Laboratories (India)
  Offers contract manufacturing for fluconazole API, with facilities capable of producing API tailored for sterile, hospital-quality infusion products, including validation for low endotoxin levels compatible with infusion standards.[7]

• Cerbios-Pharma (Switzerland)
  Specializes in sterile APIs and formulations, including high-grade fluconazole API dedicated to injectable products, with strict compliance to European regulations.[8]

• API Pharma Solutions (USA)
  Provides high-quality APIs with a focus on sterile pharmaceutical-grade fluconazole, accommodating custom specifications for secure infusion preparations.[9]

Quality and Regulatory Compliance

When sourcing fluconazole API for infusion in sodium chloride 0.9%, manufacturers must prioritize suppliers with comprehensive Certificates of Analysis (CoA), endotoxin and microbial limits testing, and full compliance with pharmacopeial standards (USP, EP, JP). Suppliers with GMP certification and proven regulatory track records are preferred to mitigate risks associated with contamination, inconsistent potency, or regulatory non-compliance.

Supply Chain Considerations

• Regulatory Approvals: Confirm that API suppliers hold approvals relevant to target markets, including Drug Master Files (DMF) submissions and FDA or EMA certification.
• Batch Consistency & Documentation: Reliable suppliers should provide thorough batch records, stability data, and rigorous quality controls to ensure product uniformity.
• Pricing and Lead Times: Competitive pricing, coupled with predictable lead times, is essential for manufacturing continuity, especially considering the complexities of sterile API handling.

Emerging Trends & Future Outlook

The increasing demand for ready-to-infuse antifungal drugs drives innovation among API producers toward more sustainable synthesis methods, improved purity profiles, and enhanced compliance practices. Additionally, strategic sourcing from regional manufacturers can mitigate supply chain disruptions.

Sustainable manufacturing, including environmentally friendly solvents and waste management practices, is becoming a differentiating factor among API suppliers serving sterile pharmaceutical markets. As global health systems emphasize supply security, diversification of API sources—particularly through collaborations and licensing agreements—will become paramount.

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Key Takeaways

• Leading global API manufacturers such as Fuso, Hetero, and Ming Kook provide high-quality fluconazole APIs suitable for sterile infusion formulations, including sodium chloride 0.9% solutions in plastic containers.

• Regulatory compliance and GMP certification are decisive factors in choosing API suppliers, ensuring product purity, stability, and safety for clinical and hospital use.

• Regional suppliers in India, China, and Taiwan offer cost-effective, reliable sources, with many possessing extensive certifications and export capabilities.

• Contract manufacturing organizations present flexible options, especially for companies seeking bespoke API quality tailored for infusion applications.

• Supply chain resilience can be enhanced by diversifying sources, establishing early communications, and verifying supplier certifications and documentation.

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FAQs

Q1. What are the primary criteria for selecting API sources for fluconazole in infusion formulations?
Answer: Regulatory compliance (GMP certification), high purity (>99%), batch consistency, microbial and endotoxin limits (suitable for infusion), and proven track record with regulatory approvals.

Q2. Can APIs from regional suppliers meet international standards for sterile infusion products?
Answer: Yes. Many regional suppliers adhere to international GMP standards and hold relevant certifications (FDA, EMA, etc.), ensuring their APIs are suitable for sterile infusion formulations globally.

Q3. What risks are associated with sourcing fluconazole API from unverified suppliers?
Answer: Risks include contamination, inconsistent potency, regulatory rejection, supply interruptions, and possible product recalls.

Q4. Are there specific certifications needed for APIs used in injectable formulations?
Answer: Yes. Certificates of Analysis, GMP certification, endotoxin and microbial limits testing, and compliance with pharmacopeial standards (USP, EP, JP) are essential.

Q5. How does the choice of API supplier impact overall drug manufacturing costs and timelines?
Answer: Qualified suppliers with reliable lead times and competitive prices can optimize production schedules, reduce costs associated with delays or non-compliance, and ensure timely supply to meet market demands.

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References

[1] Fuso Pharmaceutical Industries, Ltd. Product Specifications and GMP Certification.
[2] Hetero Labs Ltd. API Quality & Certification Data.
[3] Ming Kook Enterprise Co., Ltd. API Quality Standards and GMP Compliance.
[4] Zhejiang Hisun Pharmaceutical Co., Ltd. API Manufacturing & Regulatory Approvals.
[5] Hindustan Antibiotics Ltd. API Production and Export Data.
[6] Sun Pharmaceutical Industries Ltd. API Quality and Supply Chain Information.
[7] Dr. Reddy’s Laboratories. Contract API Manufacturing Details.
[8] Cerbios-Pharma. GMP Certification and Sterile API Capabilities.
[9] API Pharma Solutions. Quality Standards and Supply Chain Data.