Suppliers and packagers for avycaz

avycaz

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494	NDA	Allergan, Inc.	0456-2700-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0456-2700-10) / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0456-2700-01)	2014-12-26

Suppliers for the Pharmaceutical Drug: Avycaz

Last updated: July 29, 2025

Introduction

Avycaz (ceftazidime avibactam) is a broad-spectrum β-lactam antibiotic approval by the U.S. Food and Drug Administration (FDA) in 2015, designed to combat multi-drug resistant (MDR) bacterial infections. Its unique mechanism, combining ceftazidime with the novel β-lactamase inhibitor avibactam, positions it as a critical asset in combating challenging infections, especially those caused by carbapenem-resistant Enterobacteriaceae (CRE). As demand for Avycaz increases globally, identifying and understanding its key suppliers becomes imperative for stakeholders, including healthcare providers, pharmaceutical distributors, and investors.

This report offers an in-depth analysis of the primary suppliers involved in the manufacturing, development, and distribution of Avycaz, considering their manufacturing capacity, geographic footprints, regulatory compliance, and strategic role in the drug's supply chain.

Manufacturers and Licensed Producers of Avycaz

1. Pfizer Inc.

Overview:
Pfizer holds the patent rights and commercial manufacturing license for Avycaz, developed through a collaboration with AstraZeneca. Pfizer acquired the rights to the drug from AstraZeneca as part of its broader efforts to expand its antibiotic portfolio.

Manufacturing Capabilities:
Pfizer’s global network includes multiple manufacturing sites capable of producing Avycaz at scale. Its facilities in the United States and Europe have been approved by the FDA and relevant European regulators, ensuring compliance with Good Manufacturing Practices (GMP). These facilities are optimized for sterile drug production, ensuring high-quality output suitable for global distribution.

Supply Chain and Distribution:
Pfizer's extensive distribution network leverages both direct sales and licensing agreements. The company's logistical infrastructure supports the rapid deployment of Avycaz, particularly within North America, Europe, and select emerging markets.

Regulatory Approvals:
Pfizer's manufacturing sites for Avycaz are certified by U.S. FDA, EMA, and other regulatory bodies, safeguarding supply reliability and quality standards.

2. Merck KGaA (EMD Serono in the U.S.)

Overview:
While Pfizer remains the primary commercial manufacturer, Merck KGaA has historically been involved in similar β-lactamase inhibitors development and has potential licensing rights for components or related molecules. The extent of Merck’s current role in Avycaz's supply chain is limited but noteworthy due to their research capabilities and regional manufacturing expertise.

Potential Role:
Merck KGaA’s role may include specialized manufacturing of active pharmaceutical ingredients (APIs) or assistance in regional distribution, especially within Europe and Asia, owing to their regional regulatory approvals.

3. Contract Manufacturing Organizations (CMOs)

Overview:
Beyond primary license holders, several CMOs have been contracted to support manufacturing demand, especially during periods of supply constraint or for regionalization purposes. CMOs specializing in sterile injectables are crucial in scaling production.

Examples include:

• Lonza (Switzerland): Known for high-quality sterile manufacturing, possibly supporting API synthesis or finished product assembly.
• Catalent (United States/Europe): Offers fill-finish services and formulation manufacturing, supporting global distribution.
• Fujifilm Diosynth Biotechnologies: Provides biomanufacturing services that complement sterile SKUs, ensuring flexibility and capacity.

4. Active Pharmaceutical Ingredient (API) Suppliers

API Synthesis:
The core components of Avycaz—ceftazidime and avibactam—are produced by specialized API manufacturers. These include:

• Almac Group: Earlier involved in API development, potentially supplying components for Avycaz.
• Hoffmann-La Roche and other large pharma API suppliers that manufacture ceftazidime at scale, often exporting to licensing partners.

Avibactam Synthesis:
A novel β-lactamase inhibitor, avibactam's synthesis requires specialized bioengineering, typically supplied by biotech companies with expertise in β-lactamase inhibitors and complex organic synthesis.

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Supply Chain Considerations

Regulatory Compliance and Quality Control

Ensuring supply chain integrity involves adherence to GMP standards across all manufacturing sites. Pfizer’s established global footprint guarantees compliance with FDA, EMA, and other regulatory standards. The involvement of CMOs necessitates stringent oversight to prevent supply disruptions and maintain quality.

Geopolitical and Market Dynamics

Trade policies and tariffs influence the sourcing decisions of pharmaceutical companies. Regional manufacturing facilities in North America, Europe, and Asia help mitigate risks associated with geopolitical instability or supply chain disruptions, such as those experienced during the COVID-19 pandemic.

Supply Risks and Mitigation

Supply continuity depends on the stability of manufacturing partners, capacity expansion, and raw material availability. Pfizer’s diversified manufacturing footprint and partnerships with CMOs serve as buffers against potential shortages.

Emerging Suppliers and Future Trends

Biotech Innovators:
Innovators focusing on combating MDR pathogens are pursuing next-generation β-lactamase inhibitors, which may supplement or replace Avycaz in future formulations. Companies like Alopexx and Nabriva Therapeutics explore such candidates, potentially influencing the supply landscape.

Regional Production Expansion:
In response to rising global demand, Pfizer and partners are increasingly investing in regional manufacturing hubs, particularly in Asia-Pacific, to ensure access and reduce costs.

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Conclusion

Pfizer remains the principal supplier and manufacturer for Avycaz, leveraging its extensive global footprint, regulatory approvals, and manufacturing capacity. The strategic use of CMOs and regional manufacturing facilities enhances supply resilience. While alternative API suppliers and biotech partners play a smaller but vital role, the stability and regulation-compliance of Pfizer’s supply chain underpin Avycaz's availability worldwide.

As the demand for MDR infection treatments grows, continuous capacity expansion, diversification of suppliers, and robust quality controls will be essential. Close monitoring of supply chain developments will help stakeholders avoid shortages and ensure timely access to this critical antibiotic.

Key Takeaways

• Pfizer dominates Avycaz's supply chain with established manufacturing sites complying with global regulatory standards.
• CMOs and regional manufacturing hubs support capacity and mitigate supply risks.
• API sourcing involves specialized biotech and chemical manufacturers, ensuring availability of ceftazidime and avibactam.
• Regulatory compliance and quality assurance are crucial for supply security amidst growing global demand.
• Future supply chain strategies include expanding regional manufacturing and developing next-generation β-lactam inhibitors.

FAQs

1. Who are the primary manufacturers of Avycaz?
Pfizer Inc. is the main manufacturer, holding exclusive rights and possessing extensive GMP-compliant facilities globally. CMOs and regional production sites supplement Pfizer’s capacity.

2. Can other pharmaceutical companies produce Avycaz?
While Pfizer is the exclusive licensor, licensed pharmaceutical manufacturers can produce Avycaz under agreements; however, Pfizer maintains the primary manufacturing rights.

3. Are there regional differences in Avycaz supply?
Yes, Pfizer’s manufacturing facilities and regional licensing agreements influence availability, leading to variable supply chains tailored for North America, Europe, and emerging markets.

4. What challenges threaten the supply of Avycaz?
Supply disruptions may arise from raw material shortages, manufacturing capacity constraints, geopolitical issues, regulatory hurdles, or pandemic-related disruptions.

5. Are there alternative drugs similar to Avycaz?
Several novel β-lactamase inhibitors and antibiotics are under development, but Avycaz remains a frontline agent against MDR infections. Ongoing innovation may introduce alternatives in the future.

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Sources:

1. U.S. Food and Drug Administration (FDA). Avycaz Approval Information.
2. Pfizer Inc. Annual Reports and Investor Presentations.
3. European Medicines Agency (EMA). Avycaz Summary of Product Characteristics.
4. Industry reports on pharmaceutical supply chains and manufacturing collaborations.
5. Clinical pharmacology and biotech literature on β-lactamase inhibitors.