Bulk Pharmaceutical API Sources for DIFLUCAN IN SODIUM CHLORIDE 0.9%

Bulk Pharmaceutical API Sources for DIFLUCAN IN SODIUM CHLORIDE 0.9%

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%

Last updated: August 4, 2025

Introduction

The pharmaceutical industry’s reliance on high-quality Active Pharmaceutical Ingredients (APIs) is pivotal for ensuring drug efficacy, safety, and regulatory compliance. Diflucan (fluconazole), an antifungal medication, is commonly administered via intravenous infusion mixed with sodium chloride 0.9%, a standard diluent used for solution stabilization and patient delivery. This article examines the primary sources for bulk fluconazole API suitable for formulation in sodium chloride 0.9%. Emphasis is given to manufacturers' reputation, regulatory status, global presence, and supply reliability—factors critical for pharmaceutical companies seeking dependable API partners.

Understanding Diflucan (Fluconazole) API and Its Significance in Sodium Chloride Solutions

Fluconazole, a triazole antifungal, inhibits fungal ergosterol synthesis, effectively treating candidiasis, cryptococcal meningitis, and other systemic fungal infections [1]. Its intravenous formulation, often delivered in 0.9% sodium chloride solution, requires API sources adhering to stringent Good Manufacturing Practices (GMP). The API’s quality directly influences the stability and bioavailability of the final product, thus shaping its therapeutic profile.

Major Global API Suppliers for Fluconazole

1. Major Manufacturers and Their Capabilities

Several reputable API manufacturers supply pharmaceutical-grade fluconazole suitable for intravenous formulations:

• Hetero Labs Limited (India):
  A leading global generic pharmaceutical ingredient supplier, Hetero offers high-purity fluconazole API compliant with international standards (e.g., EP, USP, JP). Their manufacturing facilities are GMP-certified, with a strong track record supplying to the global market, including sterile formulations integrated with sodium chloride solutions [2].

• Mundipharm (India):
  Recognized for robust API manufacturing capacity, Mundipharm produces fluconazole API with high purity levels, regulatory compliance, and consistent supply performances. Their APIs adhere to rigorous quality standards suitable for injection-grade formulations [3].

• Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. (China):
  As a key Chinese API manufacturer, Tianyuan supplies fluconazole with active USP and EP specifications. They leverage modern manufacturing processes and GMP certifications, making them a reliable source for injectable APIs [4].

• Dr. Reddy’s Laboratories (India):
  Known for its diversified product portfolio, Dr. Reddy’s produces high-quality fluconazole APIs, complying with global standards. Their manufacturing facilities are routinely inspected by international regulatory agencies, reinforcing their credibility [5].

• Zhejiang Medicine Co., Ltd. (China):
  This pharmaceutical company produces fluconazole API suitable for injectable formulations, with facilities certified for GMP operations, ensuring quality and regulatory compliance for global markets.

2. Emerging and Niche API Suppliers

While the above-listed manufacturers dominate the supply chain, several smaller or emerging API makers are expanding their market share:

• Biological E. Limited (India):
  Offers fluconazole API with a focus on cost-competitiveness and regulatory positioning, suited for volume-based needs in developing markets.

• Aurobindo Pharma (India):
  Supplies fluconazole API with validated synthetic processes, available for formulations requiring sterile compatibility, including solutions in sodium chloride 0.9%.

Key Qualitative Factors for API Source Evaluation

Regulatory Compliance:
Ensuring APIs meet pharmacopeial standards (USP, EP, JP) and possess necessary Certificates of Suitability (CDS) or Drug Master Files (DMF) is fundamental. Manufacturers with approved DMFs facilitate smoother registration processes.

Manufacturing Quality & GMP Certification:
GMP compliance signifies that APIs are produced in environments adhering to strict quality control measures. Certification audits by agencies like the US FDA, EMA, or TGA attest to manufacturing reliability.

Supply Chain Reliability:
A consistent supply chain minimizes the risk of manufacturing delays. Manufacturers with diversified production facilities and strong logistical networks are preferred.

Pricing & Market Competitiveness:
Cost-effective API sourcing requires balancing quality standards with competitive pricing—especially for large-volume needs in hospital and infusion markets.

Supply Chain Risks and Considerations

• Geopolitical Factors: US sanctions, trade policies, or import restrictions impact API availability, especially from Chinese manufacturers.
• Regulatory Changes: Evolving regulations may affect manufacturing practices and approval status.
• Quality Variability: Ensuring API consistency, especially with complex APIs like fluconazole, demands rigorous vendor audits.

Regulatory & Importation Aspects

• Import Registrations: Manufacturers must have extensive documentation to facilitate import into target markets.
• Certificate of Analysis (CoA): Critical for verifying purity, potency, and compliance.
• Batch Size & Lead Time: Suppliers with flexible batch sizes and rapid lead times support just-in-time inventory models.

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Conclusion

Sourcing high-quality API for injectable fluconazole in sodium chloride 0.9% hinges on selecting suppliers with proven GMP compliance, robust regulatory registration, reliable supply chains, and competitive pricing. Indian manufacturers such as Hetero, Dr. Reddy’s, and Aurobindo stand out due to their extensive manufacturing capabilities, regulatory adherence, and global distribution networks. Chinese manufacturers like Zhejiang Tianyuan and Zhejiang Medicine present additional options, offering competitive pricing and increasing quality assurance through improved GMP standards.

For pharmaceutical companies, rigorous supplier qualification, regulatory due diligence, and continuous supply chain monitoring remain essential to maintaining drug stability, efficacy, and regulatory compliance.

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Key Takeaways

• Quality & Compliance First: Prioritize manufacturers with validated GMP facilities, approved DMFs, and standard compliance (USP, EP, JP).
• Diverse Supplier Portfolio: Maintain relationships with multiple vendors across regions to mitigate supply disruption risks.
• Regulatory Strategy: Confirm supplier certifications and documentation to streamline import and registration processes.
• Supply Chain Resilience: Evaluate production capacity and logistical capabilities to ensure consistent API availability.
• Price and Performance Balance: While cost is crucial, never compromise on quality; optimize procurement strategies for long-term regulatory and commercial success.

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FAQs

1. What are the primary sources for bulk fluconazole API suitable for intravenous formulation?
Major suppliers include Hetero Labs, Dr. Reddy’s, Aurobindo Pharma (India), and Zhejiang Tianyuan Bio-Pharmaceutical (China), all holding GMP certification and regulatory approvals.

2. How does GMP certification influence API sourcing decisions?
GMP certification confirms adherence to strict manufacturing standards, critical for injectable APIs like fluconazole, ensuring safety, efficacy, and regulatory approval likelihood.

3. Are Chinese API manufacturers reliable for pharmaceutical-grade fluconazole?
Yes, many Chinese manufacturers, such as Zhejiang Tianyuan and Zhejiang Medicine, have GMP-certified facilities producing APIs that meet international standards, but due diligence on quality and regulatory documentation remains essential.

4. What risks are associated with sourcing APIs from emerging manufacturers?
Risks include inconsistent quality, regulatory non-compliance, supply chain disruptions, and limited documentation. Thorough auditing and qualification are necessary.

5. How can pharmaceutical companies mitigate supply risks in API procurement?
Diversify supplier relationships, conduct regular quality audits, establish reliable logistics channels, and maintain inventory buffers to counteract potential shortages or delays.

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Sources:

1. World Health Organization. Fluconazole. [Online] Available: https://www.who.int/medicines/areas/quality_safety/quality_assurance/QA_Programme.pdf
2. Hetero Labs Limited. Product Portfolio & Quality Standards. [Online] Available: https://heteroworld.com
3. Mundipharm. API Manufacturing Capabilities. [Online] Available: https://mundipharm.com/products
4. Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. GMP and Product Data. [Online] Available: http://zjtypharm.com
5. Dr. Reddy’s Laboratories. Quality & Compliance Statements. [Online] Available: https://drreddys.com