Bulk Pharmaceutical API Sources for FORTAZ

Bulk Pharmaceutical API Sources for FORTAZ

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS015951273
AbaChemScene		CS-2810
MedChemexpress MCE		HY-B0593
BOC Sciences		72558-82-8
AbovChem LLC		HY-B0593
Sigma-Aldrich		CDS020667_ALDRICH
Molport		MolPort-006-137-763

Bulk Active Pharmaceutical Ingredient (API) Sources for FORTAZ (Cefazolin)

Last updated: July 27, 2025

Introduction

Fortaz, known generically as Cefazolin, is a first-generation cephalosporin antibiotic primarily used to treat bacterial infections. As an injectable antibiotic, its efficacy relies heavily on the quality of its Active Pharmaceutical Ingredient (API). The sourcing of Cefazolin API is critical in ensuring drug safety, efficacy, compliance with regulatory standards, and cost management. This article explores the global API manufacturing landscape, focusing on reliable, compliant suppliers capable of producing high-quality Cefazolin at scale.

Market Overview of Cefazolin API

The global Cefazolin API market is characterized by a limited number of high-purity producers, predominantly located in Asia, India, and Europe, with a growing number of Chinese and Indian manufacturers meeting international quality standards. Major pharmaceutical API producers operate under strict Good Manufacturing Practice (GMP) guidelines mandated by agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and PMDA (Pharmaceuticals and Medical Devices Agency, Japan).

The demand for Cefazolin API aligns with the expanding antibiotic market, driven by a rising prevalence of bacterial infections and increased antibiotic stewardship programs encouraging the use of approved, high-quality generics. Notably, the ongoing global need for reliable supply chains emphasizes the importance of diversified sourcing.

Key Criteria for Selecting Cefazolin API Suppliers

When evaluating sources for Cefazolin API, considerations extend beyond mere production capacity. Key attributes include:

• Regulatory Compliance: Suppliers must demonstrate adherence to GMP, ISO certifications, and quality control standards.
• Manufacturing Capacity: Adequate volume capabilities to meet supply chain demands.
• Purity and Quality: APIs should meet pharmacopeial specifications (USP, EP, or JP standards).
• Traceability and Documentation: Transparent supply chains, detailed batch records, and thorough analytical data.
• Pricing and Delivery Terms: Competitive pricing aligned with quality, with flexible delivery options.
• Reputation and Track Record: Proven reliability and consistent quality over time.

Leading Global API Manufacturers for Cefazolin

Below are prominent API suppliers recognized for their Cefazolin product offerings, based on industry reputation, capacity, and compliance history:

1. Huahai Pharmaceutical (China)

Huahai is a major Chinese API manufacturer with extensive experience producing cephalosporin APIs, including Cefazolin. The company holds GMP certification recognized internationally and complies with stringent quality standards, serving global markets.

Strengths:

• Large-scale manufacturing capacity.
• Established export footprint.
• Proven adherence to international quality and regulatory standards.

2. Shandong Luyuan Pharmaceutical (China)

Specializing in cephalosporin antibiotics, Shandong Luyuan has multiple GMP-certified production lines capable of supplying Cefazolin API in bulk quantities. Their products are widely used globally, backed by comprehensive quality documentation.

Strengths:

• Cost-competitive sourcing.
• Strong focus on quality control.
• Multiple export approvals.

3. Huntsman Chemical Corporation (India)

Huntsman operates a robust API manufacturing unit in India, producing various cephalosporin APIs including Cefazolin. They adhere to strict ISO and cGMP standards, with Quality Assurance processes aligned with international benchmarks.

Strengths:

• Consistent API quality.
• Competitive pricing.
• Extensive regulatory filings.

4. Cofichem (India)

Cofichem is an established Indian API manufacturer with facilities approved by USFDA, EDQM, and other global regulatory bodies. They supply Cefazolin APIs that meet USP and EP standards with comprehensive analytical data.

Strengths:

• FDA-approved facilities.
• High-quality compliance.
• Reliable supply chain.

5. Jiangsu Hengrui Pharmaceutical (China)

Jiangsu Hengrui is a leading Asian pharmaceutical company with capabilities in cephalosporin API production. Their Cefazolin API conforms to international pharmacopeial quality standards, with multiple GMP certifications.

Strengths:

• Advanced R&D and manufacturing infrastructure.
• Global export experience.
• Emphasis on quality assurance.

6. Fareva (France)

Fareva specializes in custom manufacturing and high-potency APIs, including cephalosporins like Cefazolin. Their operations are under strict European GMP standards, with a reputation for high-quality, consistent APIs.

Strengths:

• European manufacturing standards.
• Experience with complex APIs.
• Strong regulatory compliance.

7. Zhejiang Sanmo Pharmaceutical (China)

Specializing in antibiotics, Zhejiang Sanmo produces Cefazolin API with certification from various regulatory authorities. Their manufacturing process emphasizes purity, reproducibility, and compliance.

Strengths:

• Cost-effective sourcing.
• Adequate capacity.
• High-quality output adhering to pharmacopeial norms.

Emerging Sources and Alternative Suppliers

In addition to established producers, the market shows a burgeoning number of smaller or newer API manufacturers, primarily in India and China, increasingly achieving international standards. These suppliers can be suitable for procurement strategies emphasizing diversification and cost optimization, provided they demonstrate robust quality assurance and regulatory compliance.

Regulatory and Quality Considerations

Choosing Cefazolin API suppliers demands rigorous due diligence, including verification of GMP certifications, audit reports, analytical validation, and compliance with regulatory dossiers. International agencies, including the FDA and EMA, perform inspections that international manufacturers often emulate; thus, suppliers with such approvals facilitate smoother registration and import processes.

Supply Chain Risks and Mitigation Strategies

Frequent supply chain disruptions, geopolitical issues, and quality concerns impose risks. Diversification of suppliers across geographies, maintaining strategic stockpiles, and establishing long-term partnerships with audited suppliers mitigate these risks.

Conclusion

Reliable sourcing of Cefazolin API is fundamental to ensuring the safety, efficacy, and regulatory compliance of Fortaz formulations. Leading manufacturers in China and India dominate global supply, with European players providing high adherence to stringent standards. Professionals should prioritize suppliers with proven quality records, robust regulatory compliance, and flexible capacities aligned to their procurement needs.

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Key Takeaways

• The primary Cefazolin API suppliers are located in China and India, with reputable European manufacturers as high-quality alternatives.
• Suppliers must demonstrate compliance with GMP, ISO, and pharmacopeial standards to ensure API quality.
• Due diligence, including audits and regulatory verification, is essential to mitigate supply and quality risks.
• Diversification across multiple sources enhances supply chain resilience.
• Cost considerations must be balanced with quality assurance to sustain long-term supply stability.

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Frequently Asked Questions (FAQs)

1. What are the main factors to consider when sourcing Cefazolin API?
Primary factors include regulatory compliance (GMP certification), API purity and quality, manufacturing capacity, supplier reputation, documentation transparency, and cost-effectiveness.

2. Which countries are the leading producers of Cefazolin API?
China and India dominate production owing to their extensive pharmaceutical manufacturing infrastructure, with European suppliers providing high-standard options.

3. How can buyers ensure the quality of Cefazolin API from new suppliers?
Conduct thorough audits, review GMP and regulatory certifications, examine analytical validation reports, and request reference standards or trial batches before large-scale procurement.

4. Are there alternative APIs or formulations for Cefazolin?
While various cephalosporins exist, Cefazolin remains the standard for specific indications. Sourcing alternative formulations may require regulatory approval and should be assessed based on clinical equivalence.

5. What are the implications of sourcing Cefazolin API from non-regulated markets?
Risks include substandard quality, regulatory non-compliance, supply interruptions, and difficulties with registration and distribution. Stringent supplier qualification minimizes these risks.

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References

[1] Market research reports on cephalosporin APIs and global antibiotics market trends.
[2] Regulatory standards — U.S. Pharmacopeia, European Pharmacopoeia.
[3] API manufacturer certifications and industry reports.
[4] Company websites and industry disclosures.
[5] International regulatory agency guidelines for API quality and GMP compliance.