Bulk Pharmaceutical API Sources for CEFOPERAZONE SODIUM

Bulk Pharmaceutical API Sources for CEFOPERAZONE SODIUM

Vendor	Vendor Homepage	Vendor Sku	API Url
MolPort		MolPort-003-845-688
Oakwood Products		036517
ABBLIS Chemicals		AB1009354
ChemMol		49424343
Amadis Chemical		A834072
ChemMol		97603207
AKos Consulting & Solutions		AKOS015951266

Bulk Active Pharmaceutical Ingredient (API) Sources for: Cefoperazone Sodium

Last updated: August 19, 2025

Introduction

Cefoperazone sodium, a third-generation cephalosporin antibiotic, is widely prescribed for serious bacterial infections including respiratory tract, urinary tract, skin, and intra-abdominal infections. As a critical component in the pharmaceutical supply chain, the procurement of high-quality bulk active pharmaceutical ingredients (APIs) is vital for manufacturers to ensure product efficacy, safety, compliance, and cost-effectiveness. This article systematically examines global API suppliers specializing in cefoperazone sodium, evaluating their manufacturing capabilities, regulatory compliance, supply reliability, and market positioning.

Overview of Cefoperazone Sodium API Market

The demand for cefoperazone sodium has increased globally, especially in emerging markets where infection management remains a primary healthcare concern. The API market is characterized by a blend of large multinational companies with integrated manufacturing plants and specialized regional API producers. The global supply chain's complexity is influenced by regulatory standards, manufacturing capacities, and geopolitical factors, impacting API availability and pricing.

Major API Suppliers for Cefoperazone Sodium

1. Large-Scale International Manufacturers

A. Aurobindo Pharma

• Profile: Based in India, Aurobindo Pharma ranks as a leading API manufacturer with robust infrastructure for cephalosporin antibiotics.
• Capabilities: An ISO 9001 and cGMP-certified facility produces cefoperazone sodium with high purity standards.
• Strengths: Cost-effective manufacturing, extensive export networks, and regulatory approvals in multiple markets.
• Supply Reliability: Consistent supply histories; actively expanding capacity to meet global needs.

B. Zhejiang Hisun Pharmaceutical Co., Ltd.

• Profile: A key Chinese pharmaceutical firm with a focus on antibiotics.
• Capabilities: Offers cefoperazone sodium API produced under strict quality controls aligned with Chinese GMP standards, with subsequent certifications for international markets.
• Strengths: Competitive pricing, scalable production capacity, and a growing presence in Asia and Africa.

C. Shandong Weigao Group Medical Polymer Co., Ltd.

• Profile: Primarily involved in medical devices but also manufacturing complex APIs such as cefoperazone sodium.
• Capabilities: Maintains ISO and cGMP-compliant facilities designed for large-volume API production.
• Strengths: Integration with downstream manufacturing and strong regional distribution.

2. Mid-Sized Regional/API Specialists

A. ChemSD (India)

• Profile: Specializes in cephalosporin APIs, including cefoperazone sodium.
• Capabilities: Focused manufacturing with quality assurance compliant with international standards.
• Strengths: Agile production, customized quantities, and focused customer support.

B. Anhui Huaxing Pharmaceutical Co., Ltd.

• Profile: Chinese API manufacturer with a focus on antibiotics.
• Capabilities: Produces cefoperazone sodium with adherence to Chinese and international regulatory standards.
• Strengths: Competitive pricing and reliable delivery timelines, primarily serving the Asian and African markets.

3. Contract Manufacturing and OEM Suppliers

• Companies such as Unichem Laboratories and CordenPharma offer toll manufacturing services, producing cefoperazone sodium APIs for global clients under strict quality control. Such arrangements provide flexibility for brands in entering new markets without extensive in-house manufacturing capacity.

Quality and Regulatory Considerations

Ensuring API quality is paramount. Suppliers must comply with cGMP (current Good Manufacturing Practices) and possess relevant certifications such as ISO, COS (Certificate of Suitability), or FDA approvals. Regulatory acceptance hinges on consistent batch quality, impurity profile, residual solvents, and microbiological standards.

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are particularly stringent, requiring comprehensive documentation and demonstration of manufacturing process control. Suppliers with established regulatory dossiers facilitate quicker market entry and reduce compliance risks for pharma companies.

Supply Chain Risks and Considerations

• Geopolitical Factors: Many API suppliers are based in Asia, particularly China and India. Trade policies, tariffs, and political stability can impact supply continuity.
• Manufacturing Capacity: The COVID-19 pandemic exposed vulnerabilities related to capacity constraints, emphasizing the need for diversified supplier sourcing.
• Quality Integrity: The proliferation of non-compliant API sources increases risk of substandard products, underscoring importance of supplier qualification audits and ongoing quality monitoring.

Emerging Trends and Future Outlook

The API manufacturing landscape for cefoperazone sodium is evolving with advancements in process technology, regulatory harmonization, and stricter quality standards. Long-term trends include:

• Manufacturing Localization: Some regions are incentivizing domestic API production to reduce reliance on imports.
• Supply Chain Diversification: Pharma companies are establishing multiple supplier relationships to mitigate risks.
• Sustainability Initiatives: Eco-friendly manufacturing processes, including solvent recycling and waste minimization, are gaining prominence, aligning with global environmental expectations.

Conclusion

Securing reliable sources for cefoperazone sodium API is critical for pharmaceutical manufacturers aiming to ensure product quality, regulatory compliance, and supply continuity. Leading international suppliers such as Aurobindo, Zhejiang Hisun, and regional players like ChemSD and Anhui Huaxing provide a range of options aligned with diverse needs. Vigilant supplier qualification, due diligence, and ongoing quality assurance are essential to mitigate risks and capitalize on market opportunities effectively.

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Key Takeaways

• Top global manufacturers, notably Aurobindo and Zhejiang Hisun, dominate cefoperazone sodium API supply with extensive regulatory approvals.
• Quality compliance (cGMP certification, regulatory dossiers) is non-negotiable; suppliers with established certifications streamline market entry.
• Diversifying supply sources reduces geopolitical and capacity risks, especially amid focus on supply chain resilience.
• Regional and mid-sized API suppliers offer competitive pricing, often serving niche markets or enabling flexible manufacturing arrangements.
• Adoption of sustainable and innovative manufacturing practices will be pivotal for future API supplier competitiveness.

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Frequently Asked Questions (FAQs)

1. What are the key factors to consider when sourcing cefoperazone sodium APIs?
Quality compliance (cGMP certification), regulatory approvals (e.g., EMA, FDA), supply reliability, manufacturing capacity, and cost are critical factors influencing sourcing decisions.

2. How does supplier regulatory compliance impact API sourcing?
Regulatory compliance ensures the API meets international standards, facilitating faster approval processes and reducing the risk of regulatory sanctions or batch rejections.

3. Are Chinese API manufacturers reliable for cefoperazone sodium?
Many Chinese manufacturers adhere to strict GMP standards and possess necessary certifications. Due diligence, including supplier audits, is essential to confirm compliance and quality reliability.

4. How is supply chain risk managed in sourcing cefoperazone sodium APIs?
Diversifying suppliers, establishing long-term contractual agreements, and monitoring geopolitical developments are standard strategies to mitigate supply chain vulnerabilities.

5. What trends are shaping the future of cefoperazone sodium API manufacturing?
Enhanced process technologies, stricter regulatory harmonization, sustainability initiatives, and regional manufacturing policies are shaping the evolving competitive landscape.

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References

[1] IQVIA. The Global API Market Report. 2022.
[2] European Medicines Agency. Guidelines on Good Manufacturing Practices for APIs. 2021.
[3] U.S. FDA. Regulatory Requirements for Active Pharmaceutical Ingredients. 2022.
[4] Phama Tech Outlook. “Emerging Trends in API Manufacturing.” 2022.
[5] Industry Reports and Company Websites.

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