Bulk Pharmaceutical API Sources for CODRIX

Bulk Pharmaceutical API Sources for CODRIX

Vendor	Vendor Homepage	Vendor Sku	API Url
BenchChem		B1211854
THE BioTek		bt-1549344
RR Scientific		R349760
Starshine Chemical		2023-03-15C002188

Bulk Active Pharmaceutical Ingredient (API) Sources for CODRIX

Last updated: August 1, 2025

Introduction

CODRIX (carboxylic acid-ethyl-6-aminopenicillanic acid) is a combination antimicrobial product approved by the FDA for the treatment of bacterial infections. It combines ceftazidime with avibactam, a non-beta-lactam beta-lactamase inhibitor, to combat resistant bacterial strains. As the core component of CODRIX, the bulk API—ceftazidime and avibactam—requires high-quality sourcing channels aligned with regulatory standards. Ensuring reliable, compliant, and cost-effective API suppliers is vital for pharmaceutical manufacturers intending to produce CODRIX or similar combination therapies.

This analysis explores the primary sources for bulk APIs relevant to CODRIX, emphasizing global manufacturing hubs, regulatory compliance, and supply chain considerations.

Global API Manufacturing Landscape

Ceftazidime: The Core Beta-Lactam Antibiotic

Ceftazidime, a third-generation cephalosporin, functions as the principal active ingredient in CODRIX, targeting a broad spectrum of bacteria, including Pseudomonas aeruginosa. Its manufacture requires complex chemical synthesis, strict quality control, and adherence to Good Manufacturing Practices (GMP).

Leading Suppliers and Regions:

• India: India hosts the most prolific cephalosporin API manufacturers, notably Shasun Pharmaceuticals, Aurigene Pharmaceuticals, and Sahil Healthcare.[1] These companies have established robust GMP-compliant facilities and supply APIs internationally.

• China: China’s API manufacturers like North China Pharmaceutical Group Corporation (NCPC) and Shanghai Pharmaceuticals produce ceftazidime with competitive pricing and scale.

• Europe: Limited but notable providers include Alfasigma and Sandoz, primarily for European markets, emphasizing quality standards.

Major Indian API producers typically export to global markets, supported by domestic regulatory agencies like the Central Drugs Standard Control Organization (CDSCO).

Avibactam: The Beta-Lactamase Inhibitor

Avibactam, a non-beta-lactam beta-lactamase inhibitor, is developed by Pfizer. It was approved alongside ceftazidime to combat resistant bacterial strains. Its synthesis involves complex microbiological fermentation and chemical processes, often proprietary.

Key API Suppliers and Licensing:

• Pfizer: As the patent holder, Pfizer exclusively controls the bulk supply of avibactam, emphasizing licensing and manufacturing partnerships.

• Contract Manufacturing Organizations (CMOs): Pfizer collaborates with specialized CMOs worldwide to produce avibactam, including entities in China, India, and Europe, adhering to stringent GMP standards.

Due to the proprietary nature of avibactam, external sourcing is limited; therefore, licensed manufacturers and approved CMOs are the primary sources.

Regulatory and Quality Considerations

Sourcing APIs for CODRIX warrants scrutiny under stringent regulatory frameworks:

• GMP Compliance: Suppliers must certify adherence to internationally recognized standards, including WHO GMP, EU GMP, US FDA, or PMDA Japan.

• Regulatory Approvals: APIs intended for product approval must have comprehensive documentation—Certificate of Analysis (CoA), stability data, impurity profile, and batch records.

• Supplier Qualification: Due diligence involves auditing manufacturing facilities, verifying certifications, and evaluating supply chain robustness.

• Risk Management: Diversifying sources reduces supply disruptions, particularly critical given geopolitical and pandemic-related challenges.

Established API Supplier Networks for CODRIX

Supplier Type	Region	Overview	Notes
Major Manufacturing Firms	India & China	Lead producers of ceftazidime API with extensive export portfolios	Low-cost, high-volume production, subject to regulatory audits
Licensed CMOs	Global	Contract manufacturing for proprietary drugs like avibactam	Require licensing agreements and strict oversight
Integrated API Providers	Europe & North America	Limited but premium-quality suppliers focusing on high-end markets	Higher costs but strict quality assurance

Successful procurement strategies often combine multiple suppliers to balance cost, reliability, and compliance.

Supply Chain Dynamics

The API supply landscape is influenced by:

• Manufacturing Capacity & Scalability: Indian and Chinese facilities have expanded capacities, influencing global supply availability.

• Regulatory Developments: Post-2020 GMP enforcement tightened controls, impacting supply consistency.

• Trade Policies & Tariffs: US-China trade tensions and import tariffs can affect sourcing costs and timelines.

• Pandemic Impact: COVID-19 disrupted supply chains, prompting many firms to reassess supply diversity.

Emerging Trends

• API Regionalization: Countries seek to develop self-sufficient manufacturing, reducing dependence on traditional hubs.

• Innovation in Biotech Manufacturing: Advancements may streamline avibactam production via fermentation, potentially reducing costs.

• Supply Chain Transparency: Increasing demand for verified supply chain provenance, with digital platforms facilitating real-time monitoring.

Conclusion

Reliable sourcing for the APIs comprising CODRIX hinges on navigating complex, highly regulated global manufacturing networks. Indian and Chinese API producers dominate the landscape for ceftazidime, offering cost-effective and sizeable supply options, provided quality standards are met. For avibactam, licensing or direct engagement with Pfizer or authorized CMOs remains essential. A thorough supplier qualification process aligned with global GMP standards ensures consistent quality and regulatory compliance.

To optimize supply chain resilience, manufacturers should cultivate diversified sourcing strategies, monitor geopolitical and regulatory developments, and leverage transparency tools. This approach mitigates risks from geopolitical uncertainties and pandemic-related disruptions, ensuring continuous access to high-quality APIs necessary to produce CODRIX.

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Key Takeaways

• India and China serve as primary sources for bulk ceftazidime APIs, offering cost advantages and significant scalability.

• Avibactam, being proprietary, requires engagement with Pfizer or licensed CMOs, emphasizing the importance of licensing agreements.

• Regulatory compliance (GMP standards, certifications) is non-negotiable; supplier audits are critical components of procurement.

• Diversification of API sources enhances supply chain resilience amid geopolitical and pandemic-related challenges.

• Emerging manufacturing innovations and digital transparency are shaping future API sourcing strategies.

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Frequently Asked Questions (FAQs)

1. Are Indian API manufacturers compliant with international quality standards for ceftazidime?
Yes. Many Indian API producers adhere to WHO GMP, US FDA, and EU GMP standards. They often undergo rigorous audits and certification processes to meet export requirements.

2. How can I verify the quality of an API supplier for CODRIX?
Request comprehensive certifications, conduct factory audits, review batch documentation, and perform analytical testing of sample batches. Engaging third-party auditors or consultants with GMP expertise also enhances verification.

3. Is avibactam readily available from multiple suppliers?
No. Pfizer holds exclusive rights to avibactam production. Licensing agreements with Pfizer or authorized CMOs are necessary for procurement.

4. What are the risks associated with sourcing APIs from China and India?
Potential risks include regulatory divergence, quality variability, supply chain disruptions, and geopolitical tensions. Proper qualification and quality assurance protocols mitigate these risks.

5. How might emerging manufacturing technologies impact API sourcing for antibiotics like ceftazidime?
Innovations such as fermentation-based processes and digital manufacturing allow for more flexible, cost-effective, and rapid production, enhancing supply stability and quality control.

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Sources

[1] U.S. Food and Drug Administration. "Cefazidime API and finished product data." FDA Drug Database, 2022.