Bulk Pharmaceutical API Sources for ceftazidime sodium

Bulk Pharmaceutical API Sources for ceftazidime sodium

Vendor	Vendor Homepage	Vendor Sku	API Url
ABI Chem		AC1NUQMU
ABI Chem		AC1O426K
ZINC		ZINC3830469
Pi Chemicals		PI-10779
OChem		1496
Selleck Chemicals		S3649
Yick-Vic Chemicals & Pharmaceuticals (HK) Ltd.		PH-3659B

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

Last updated: August 2, 2025

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Introduction

Ceftazidime sodium is a third-generation cephalosporin antibiotic widely used in the treatment of severe bacterial infections, notably those caused by Pseudomonas aeruginosa. As an API, its sourcing is critical to pharmaceutical manufacturing, impacting product quality, regulatory compliance, and supply chain security. This article provides an in-depth review of primary bulk API sources for ceftazidime sodium, assessing key manufacturers, global geographical distribution, quality standards, and market dynamics to inform strategic procurement decisions for pharmaceutical companies and stakeholders.

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Overview of Ceftazidime Sodium API Market

The demand for ceftazidime sodium has surged over recent years, driven by increasing antibiotic resistance and expanding indications for serious infections. As of 2023, the API market is characterized by a mix of established multinational suppliers and emerging manufacturers, especially from regions like India, China, and Eastern Europe. Regulatory scrutiny, such as adherence to USP, EP, and WHO quality standards, influences the selection of API sources.

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Major API Suppliers for Ceftazidime Sodium

1. Indian API Manufacturers

India remains the dominant supplier of ceftazidime sodium APIs owing to its extensive generic pharmaceutical industry and competitive manufacturing costs.

• Dr. Reddy's Laboratories
  A recognized global leader, Dr. Reddy’s produces high-quality ceftazidime sodium APIs compliant with international standards. The company operates WHO-GMP and USDMF facilities, emphasizing stringent quality control processes.

• Aurobindo Pharma
  Aurobindo supplies certified APIs to global markets, leveraging its robust R&D and manufacturing infrastructure. Its API manufacturing facilities comply with national and international regulatory bodies including EU-GMP and USFDA.

• Hetero Labs
  Hetero’s product portfolio includes ceftazidime sodium APIs manufactured in cGMP-compliant facilities, with export capabilities covering North America, Europe, and South America.

• Biological E. Limited
  Focused on sterility and purity, Biological E. supplies APIs meeting WHO and USFDA standards, serving both domestic and export markets.

2. Chinese API Manufacturers

China remains a significant player, with several API producers offering competitive prices, though regulatory transparency varies.

• Shanghai Pharmaceuticals Holding Co., Ltd.
  Known for its comprehensive API manufacturing capabilities, Shanghai Pharma adheres to strict quality standards, including ISO and GMP certifications.

• Qingdao Hisea Biotech
  Specializes in cephalosporin APIs, including ceftazidime sodium, with certifications for international markets but varying regulatory recognition.

• Sichuan Kelun Pharmaceutical
  Kelun manufactures a broad portfolio of antibiotics, including ceftazidime sodium, with strict adherence to Chinese GMP standards and growing export certifications.

3. Eastern European and other Global Suppliers

While less prominent than Indian and Chinese producers, select firms in Eastern Europe and Southeast Asia meet high regulatory standards.

• Polpharma (Poland)
  A major European manufacturer, Polpharma offers APIs with compliance to European Union Good Manufacturing Practices (EU-GMP), appealing to markets with stringent regulatory requirements.

• Ipca Laboratories (India)
  Noted for quality and scale, Ipca’s APIs meet international standards and are widely used globally.

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Regulatory and Quality Considerations

Ensuring API quality is paramount. Suppliers must demonstrate compliance with Good Manufacturing Practices (GMP), have appropriate regulatory filings (USDMF, CEP, DMF), and pass rigorous quality audits. Key quality parameters include:

• Impurity Profiles: Certification that APIs contain minimal impurities, crucial for reducing safety risks.
• Sterility and Stability: Especially relevant for ceftazidime sodium, which is often supplied as a sterile powder.
• Analytical Validation: Suppliers should provide comprehensive analytical data compliant with pharmacopeial standards.

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Market Dynamics Influencing API Source Selection

• Cost Competitiveness: Indian and Chinese API producers offer the most competitive pricing, but cost considerations must be balanced against quality and regulatory acceptance.
• Supply Chain Security: Diversification among suppliers mitigates risk of disruptions from geopolitical issues, natural disasters, or regulatory crackdowns.
• Regulatory Acceptance: Suppliers with established regulatory dossiers (DMFs, CEPs) streamline registration processes and reduce approval times.
• Environmental and Ethical Standards: Increasing emphasis on sustainable practices influences procurement decisions, favoring suppliers with robust Environmental, Social, and Governance (ESG) policies.

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Assessment of Key API Manufacturers

Manufacturer	Region	Regulatory Certifications	Production Capacity	Notable Strengths
Dr. Reddy’s Laboratories	India	USFDA, EU-GMP, WHO-GMP	High	Quality assurance, global reach
Aurobindo Pharma	India	USFDA, EMA, WHO-GMP	High	Cost-effective, diverse portfolio
Hetero Labs	India	USFDA, WHO-GMP	Moderate	Strategic partnerships
Shanghai Pharmaceuticals	China	ISO, GMP, CE Mark	Moderate	Market-specific regulatory approvals
Polpharma	Poland	EU-GMP	Moderate	European market compliance

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Strategic Procurement Insights

Manufacturers seeking reliable sources of ceftazidime sodium API should prioritize suppliers with:

• International GMP compliance and documented regulatory dossiers.
• Proven track record for consistent quality and supply.
• Transparent impurity profiles and analytical validation.
• Robust Quality Assurance and Quality Control (QA/QC) systems.
• Capacity for large-scale production to meet global demand fluctuations.

Emerging suppliers from India and China provide cost advantages but must be validated for long-term regulatory compliance and quality management systems. European and North American suppliers offer premium assurance, suitable for markets with strict regulatory standards, albeit at higher costs.

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Conclusion

The sourcing landscape for ceftazidime sodium API is predominantly characterized by Indian and Chinese manufacturers, with select European firms catering to high-compliance markets. Strategic sourcing requires balancing cost, quality, regulatory acceptance, and supply chain resilience. Diversifying suppliers and emphasizing quality assurance standards are essential for maintaining supply stability and meeting stringent regulatory landscapes.

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Key Takeaways

• Indian API producers dominate global supply for ceftazidime sodium due to cost efficiency and manufacturing capacity.
• Regulatory compliance, including USFDA, EMA, and WHO-GMP certifications, is critical for international market access.
• Quality assurance, impurity profiling, and validated analytical data are non-negotiable factors in supplier selection.
• Diversifying suppliers minimizes supply chain risks amid geopolitical and regulatory uncertainties.
• European suppliers provide high compliance standards suitable for markets with stringent requirements but at a premium.

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FAQs

1. What are the primary regions supplying bulk ceftazidime sodium API?
India and China are the leading regions, with a smaller but growing European presence catering to markets with strict regulatory requirements.

2. How do I verify the regulatory compliance of an API supplier?
Request detailed dossiers such as Drug Master Files (DMFs), Certificates of Suitability (CEP), and GMP certificates. Conduct site audits and review analytical validation data.

3. Why is regulatory certification important in API sourcing?
Regulatory certifications ensure the API meets safety, efficacy, and quality standards required by registration authorities like the USFDA, EMA, and WHO.

4. What are the common quality concerns with ceftazidime sodium APIs?
Impurities, endotoxin levels, sterility, and stability are critical quality parameters requiring rigorous verification.

5. Can emerging Asian suppliers meet international quality standards?
Yes, many emerging Asian suppliers have invested in compliance and quality systems, but due diligence and validation are essential before procurement.

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Sources:

1. [1] Pharma intelligence reports and industry publications on cephalosporin API market.
2. [2] Official websites and regulatory filings of key API manufacturers.
3. [3] World Health Organization (WHO) guidelines on pharmaceutical quality standards.
4. [4] U.S. Food and Drug Administration (FDA) databases for DMFs and manufacturing authorizations.
5. [5] European Medicines Agency (EMA) approval lists for active ingredients.