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

Bulk Pharmaceutical API Sources for DIFLUCAN 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
IS Chemical Technology		I06-0069

Last updated: July 31, 2025

lk Active Pharmaceutical Ingredient (API) Sources for: Diflucan in Dextrose 5% in Plastic Container

Introduction
The global demand for antifungal agents like Diflucan (fluconazole) has surged, driven by increasing fungal infection prevalence and expanding therapeutic applications. Specifically, formulations such as Diflucan in dextrose 5% solutions packaged in plastic containers are vital for IV administration. Ensuring reliable, high-quality API sourcing is crucial for pharmaceutical manufacturers aiming to produce such formulations. This article offers a comprehensive overview of primary API sources for fluconazole, emphasizing considerations for sourcing to maintain product quality, regulatory compliance, and cost efficiency.

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Understanding Diflucan (Fluconazole) and its API Requirements
Diflucan is a widely used triazole antifungal medication indicated for systemic fungal infections. Its API, fluconazole, exhibits high oral and injectable bioavailability, making it a preferred choice in clinical settings. Manufacturing injectable formulations requires API of the highest purity and compliance with pharmacopeial standards (USP, Ph.Eur., JP).

Fluconazole's chemical characteristics demand strict process controls, including control over enantiomeric purity, residual solvents, moisture content, and impurity profiles. Sourcing an API that meets these stringent criteria is crucial for regulatory approval and patient safety.

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Global API Manufacturing Regions and Leading Suppliers

1. China
China remains a dominant hub for pharmaceutical APIs, including fluconazole. Several licensed manufacturers operate at scale, offering competitive pricing and extensive production capacity. Key Chinese API producers often have Good Manufacturing Practice (GMP) certifications aligned with international standards, facilitating global distribution. Notable suppliers include Zhejiang Hisun Pharmaceuticals, North China Pharmaceutical Group Co., Ltd., and Hainan Yisheng Pharmaceutical Co., Ltd.

Pros: Cost-effective, high-volume capacity, advanced manufacturing infrastructure
Cons: Variability in regulatory oversight necessitates thorough supplier audits and due diligence

2. India
India's pharmaceutical industry ranks among the world's largest API producers, with numerous WHO-GMP and USFDA-approved facilities. Major companies like Cadila Healthcare, Strides Pharma, and Aurobindo Pharma manufacture fluconazole APIs conforming to stringent quality standards. Indian suppliers often emphasize cost competitiveness paired with high-volume production capabilities, supporting the global demand for injectable APIs.

Pros: Robust regulatory compliance, extensive experience, established export channels
Cons: Lengthier approval processes and potential supply chain complexities

3. Europe
European API producers, such as Lek Pharmaceuticals (Slovenia), Covestro (Germany), and Celltrion (Croatia), focus on high-quality APIs with a strong emphasis on regulatory compliance and purity. They largely cater to regional markets and high-end pharmaceutical companies requiring APIs with strict quality controls.

Pros: High regulatory standards, transparency, and reliable supply chain
Cons: Higher price point compared to Asian suppliers

4. United States and Other Qualified Markets
Limited direct production exists within the US for fluconazole APIs; manufacturers typically import from European or Asian suppliers. US-based companies often source from established international API manufacturers to meet regulatory benchmarks.

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Key Considerations for API Sourcing of Fluconazole for Injectable Formulations

A. Regulatory Compliance
API suppliers must possess relevant certifications: USFDA, EMA, WHO-GMP, or PIC/S approvals. For injectable formulations in particular, demonstrating compliance with stringent quality standards is essential.

B. Quality Attributes
Critical quality parameters include:

• Purity >99.8%
• Residual solvents below ICH limits
• Clear impurity profile with acceptable levels of process-related impurities
• Consistent enantiomeric purity

C. Manufacturing Quality Control and Validation
Manufacturers require detailed Certificates of Analysis (CoA), Batch Production Records, and Environmental Monitoring Data. Regular audits are recommended to verify adherence to Good Manufacturing Practices.

D. Supply Chain Reliability
Continuity of supply, lead times, and ability to meet regulatory batch requirements are vital. Long-term partnerships with dependable API manufacturers reduce risks of supply disruptions.

E. Cost Efficiency
While Asian suppliers offer competitive pricing, considerations around freight, import duties, and regulatory approval processes influence total cost. High-quality European APIs, though pricier, may reduce validation timelines and compliance concerns.

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Top API Manufacturers for Fluconazole

Region	Manufacturer	Certifications	Highlights
China	Zhejiang Hisun Pharmaceuticals	GMP, ISO	Large-scale production, competitive pricing
India	Aurobindo Pharma	USFDA, MHRA	Extensive experience, robust quality systems
Europe	Lek Pharmaceuticals	EMA GMP	High-purity API, regulatory trust
India	Sun Pharmaceutical Industries	USFDA, WHO-GMP	Established supplier with reliable supply

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sourcing Strategies for Diflucan API in Dextrose Solutions

For injectable formulations like fluconazole in dextrose 5%, manufacturers should prioritize suppliers with demonstrated success in producing APIs suitable for infusion preparations. These APIs should have demonstrated stability in solution, relevant extractables/leachable data, and compatibility studies for dextrose formulations.

Establishing partnerships with suppliers offering comprehensive validation packages, including stability in 5% dextrose, is advisable. Additionally, consider engaging with suppliers who have experience supplying APIs for similar formulations, reducing the risk of formulation incompatibility or stability issues.

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Regulatory Pathways and Documentation

Manufacturers must prepare dossiers demonstrating API quality in accordance with regional regulatory standards. Critical documents include:

• Certificates of Analysis (CoA)
• Regulatory Certification (e.g., GMP compliance certificates)
• Batch Records and Certificates of Suitability (CEPs) or Drug Master Files (DMFs)
• Stability data specific to dextrose solutions

Coordination with API suppliers during the registration process ensures smooth importation and compliance.

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Future Trends and Emerging Sources

Advances in continuous manufacturing and process analytical technology (PAT) are enabling improved API quality and supply consistency. Emerging suppliers from Southeast Asia and Latin America are entering the market, offering new options for cost and supply chain diversification.

Pharmaceutical companies should monitor these developments, conduct rigorous qualification processes, and integrate sustainable procurement strategies.

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Key Takeaways

• The primary API sources for fluconazole include reputable manufacturers in China, India, and Europe, each with distinct advantages.
• Compliance with GMP, stringent quality control, and regulatory certifications are non-negotiable criteria for sourcing APIs utilized in injectable formulations.
• Cost considerations should be balanced with supply chain reliability, quality assurance, and regulatory compliance to avoid costly delays or product recalls.
• Establishing long-term, validated relationships with trusted API suppliers mitigates risks associated with supply disruptions and quality variability.
• Proactive monitoring of emerging manufacturing hubs and technological advancements is vital for maintaining competitive advantage and compliance.

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FAQs

Q1: What are the critical quality parameters for fluconazole API used in injectable formulations?
Answer: Purity (>99.8%), low residual solvents, acceptable impurity profile, enantiomeric purity, and stability data are vital for ensuring API suitability in injectables.

Q2: How can companies verify the regulatory compliance of API suppliers?
Answer: Request certifications such as WHO-GMP, USFDA, EMA approvals, and detailed regulatory dossiers including Certificates of Analysis, Certificates of Suitability, and audit reports.

Q3: Is it necessary to source fluconazole API from regional manufacturers for injectable use?
Answer: Not necessarily; while regional sources may offer logistical advantages, global suppliers with proven quality and compliance can also meet regulatory requirements effectively.

Q4: What challenges are associated with sourcing fluconazole API from China?
Answer: Potential variability in quality control, regulatory oversight, and supply chain reliability. Due diligence, audits, and supplier qualification are essential to mitigate these risks.

Q5: How does API quality impact the stability of Diflucan in dextrose 5% solution?
Answer: High-quality API ensures compatibility and stability in infusion solutions. Impurities or variability in API can compromise shelf-life, efficacy, and safety of the final product.

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References
[1] USP Pharmacopoeia. "Fluconazole Monograph." United States Pharmacopoeia, 2022.
[2] EMA. "Guideline on the specifications for pharmaceutical substances." European Medicines Agency, 2017.
[3] WHO. "Prequalification of Medicines Programme." World Health Organization, 2021.
[4] Smith, J. et al. "API sourcing strategies for injectable antifungals." Journal of Pharmaceutical Innovation, 2020.
[5] Transparency Market Research. "Global API Market Analysis." 2022.