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

Bulk Pharmaceutical API Sources for DIFLUCAN 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
NovoSeek		3365
IS Chemical Technology		I06-0069
Ambinter		Bio-0041

Bulk Active Pharmaceutical Ingredient (API) Sources for: DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Last updated: August 4, 2025

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Introduction

The pharmaceutical industry relies heavily on the reliable sourcing of Active Pharmaceutical Ingredients (APIs). For formulations like Diflucan (fluconazole) in sodium chloride 0.9% intravenous solutions, sourcing high-quality APIs is crucial to ensure safety, efficacy, and compliance. This article explores global bulk API sources for fluconazole, vital for manufacturing Diflucan in saline infusion, emphasizing supply chain considerations, regulatory compliance, and vendor profiles.

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Understanding the API: Fluconazole

Fluconazole is an antifungal triazole used to treat systemic fungal infections. Its manufacturing requires strict adherence to Good Manufacturing Practices (GMP). The API's purity, stability, and bioactivity are instrumental for therapeutic effectiveness.

The focus here is on sourcing bulk fluconazole API that complies with pharmacopeial standards (USP, EP, JP) necessary for pharmaceutical injectable products. The API must meet stringent quality norms, including limited impurity profiles, residual solvents, and potency specifications.

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Global API Producers for Fluconazole

1. Major API Manufacturers

a. Zhongxi Pharmaceutical Co., Ltd. (China)
Zhongxi Pharmaceutical is a leading producer of APIs including fluconazole. The company has facilities certified under international standards such as ISO 9001 and GMP, enabling them to supply APIs for parenteral formulations. Their fluconazole API conforms to USP and other pharmacopoeias, with a robust export footprint across North America, Europe, and Asia.

b. Zhejiang Xianju Pharmaceutical Co., Ltd. (China)
Xianju Pharmaceutical specializes in antifungal APIs and finished dosage forms. Their fluconazole API is manufactured under GMP standards, with supply agreements often validated by major pharmaceutical firms. Xianju’s API conforms to international pharmacopoeias and has documented stability profiles.

c. Synthesis and Contract Manufacturing Organizations (CMOs) in India
India's pharma industry features prominent API manufacturers like

• Bharat Biotech,
• Glenmark Pharmaceuticals, and
• Dr. Reddy's Laboratories.

They produce high-quality fluconazole APIs for export, complying with WHO-GMP standards. These sources are competitive and often serve as primary suppliers for global formulations.

d. European and North American API Producers
While less common, several high-quality sources like Fresenius Kabi (Germany) and Mundipharma (USA) manufacture APIs suitable for injectable products. They emphasize rigorous certification, traceability, and compliance with international standards.

2. Contract Manufacturing & Supply Chain Dynamics

Global reliance on CMOs enhances flexibility and reduces time-to-market. Companies such as Hutchison China MediTech and Fujifilm Diosynth Biotechnologies partner with pharmaceutical firms for custom API manufacturing, ensuring adherence to quality standards.

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Regulatory Compliance and Quality Standards

For APIs used in injectable products, adherence to regulations such as FDA (USA), EMA (Europe), and PMDA (Japan) is non-negotiable. Suppliers must furnish comprehensive documentation, including Certificates of Analysis (CoA), comprehensive impurity profiles, and stability data.

GMP compliance remains the benchmark; APIs produced under GMP assure minimal risk of contamination and variability. Many sources align their operations with ICH Q7 guidelines, essential for APIs destined for parenteral use.

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Supply Chain Considerations

• Quality Certifications: Prioritize vendors with GMP certification, FDA approval (if applicable), and pharmacopoeial compliance.
• Traceability: Ensure transparent provenance chains, especially for APIs produced in regions with varying regulatory oversight.
• Lead Times & Capacity: Confirm vendors' manufacturing capacities align with demand forecasts, with contingency plans for supply disruptions.
• Pricing & Contract Terms: Competitive pricing must be balanced with quality assurance regulatory compliance.

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Emerging Trends and Alternatives

Recently, the wave of regional API manufacturing has aimed at reducing reliance on a limited set of suppliers. India and China remain dominant, but alternative sources such as South Korea and Eastern Europe are gaining prominence. Future supply chains may favor diversified sourcing to mitigate geopolitical and logistical risks.

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Conclusion

Sourcing high-quality bulk fluconazole API for manufacturing Diflucan in sodium chloride 0.9% infusion involves navigating a complex landscape of global suppliers, regulatory standards, and supply chain robustness. Leading Chinese manufacturers like Zhongxi and Zhejiang Xianju, Indian CMOs such as Dr. Reddy’s, and specialized European suppliers constitute primary sources. Rigorous quality evaluations and compliance with global standards underpin reliable sourcing, ensuring the final product’s safety and efficacy.

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Key Takeaways

• Reliable API sourcing hinges on vendors with GMP certification, comprehensive documentation, and proven regulatory compliance.
• China and India dominate global fluconazole API production, with increasing diversification toward Europe and North America.
• Contract manufacturing organizations enhance capacity flexibility, but due diligence on quality and supply stability remains essential.
• Regulatory adherence to USP, EP, and other pharmacopoeias is critical for parenteral APIs.
• Supply chain resilience benefits from vendor diversification, robust logistics, and proactive inventory management.

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FAQs

1. What are the primary factors to consider when sourcing fluconazole API for injectable formulations?
Regulatory compliance (GMP standards), purity levels, impurity profiles, stability data, supplier certifications, and supply capacity are critical factors.

2. Which regions predominantly supply high-quality fluconazole API globally?
China and India are primary suppliers, with qualified European and North American sources supplementing in high-end formulations requiring strict compliance.

3. How do regulatory standards impact API sourcing for injectable drugs?
APIs must meet stringent standards like USP, EP, or JP, with GMP certification ensuring manufacturing quality, traceability, and safety suitable for parenteral use.

4. What role do contract manufacturing organizations play in API supply chains?
CMOs expand manufacturing capacity, often offering tailored production under GMP conditions, aiding in risk mitigation and supply continuity.

5. How can companies ensure the API quality remains consistent across batches?
Through rigorous supplier qualification, regular audits, Clear specifications aligned with pharmacopoeias, and comprehensive quality control testing of each batch.

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Sources

[1] U.S. Pharmacopeia (USP) Monographs on Fluconazole.
[2] European Pharmacopoeia (EP) Standards for Antifungal Agents.
[3] API Manufacturer Profiles — Industry Reports, 2022.
[4] GMP Certification Data, Global Regulatory Agencies.
[5] Supply Chain and Logistics Reports — Pharmaceutical Insights, 2023.