Last updated: August 9, 2025
Introduction
Piperacillin-tazobactam, marketed under the brand name Zosyn, is a broad-spectrum antibiotic used extensively in hospital settings to treat severe infections, including intra-abdominal, skin, and respiratory infections. Its formulation predominantly involves a lyophilized powder, reconstituted with sterile water before infusion. For hospital and clinical use, Zosyn is supplied primarily in plastic infusion containers, aligning with modern pharmaceutical packaging standards aimed at safety, convenience, and stability. This article provides a comprehensive overview of key suppliers manufacturing Zosyn in plastic containers, elucidating the global supply landscape, manufacturing considerations, and implications for healthcare procurement.
Manufacturing & Packaging Overview of Zosyn
Zosyn is manufactured by pharmaceutical companies specialized in sterile injectable antibiotics. Its distribution in plastic containers—typically in ready-to-use infusion bags—addresses clinical safety protocols and ease of administration. The formulation process involves sterile compounding, lyophilization, and aseptic filling into plastic packaging conforming to regulatory standards.
The suppliers' capacity hinges on stringent Good Manufacturing Practices (GMP), ensuring product stability, sterility, and compatibility with infusion systems. Plastic containers used include polyethylene-based infusion bags (commonly PVC or non-PVC alternatives) validated for pharmaceutical stability.
Major Suppliers of Zosyn in Plastic Containers
1. Pfizer Inc.
Overview:
Pfizer developed Zosyn in partnership with international pharmaceutical entities. As the original manufacturer, Pfizer supplies Zosyn in various formats, including plastic infusion bags, primarily in North America and select international markets.
Product Details:
- Packaging: Sterile lyophilized powder in plastic infusion bags (typically 3.375 g piperacillin/tazobactam per bag).
- Availability: In combination with dedicated infusion systems to reconstitute into ready-to-use solutions.
Supply Capabilities:
- Pfizer maintains extensive manufacturing facilities adhering to GMP in the United States and globally, ensuring stable supply chains for Zosyn.
- The company's global footprint supports distribution in the United States, Europe, Asia, and other markets.
2. Teva Pharmaceutical Industries Ltd.
Overview:
Teva is a leading generic pharmaceutical manufacturer with significant capabilities in sterile injectables, including antibiotics akin to Zosyn.
Product Portfolio:
- While Teva offers generic piperacillin-tazobactam formulations, their supply of Zosyn specifically in plastic containers is expanding, particularly in regions where authorized generics are accepted.
Packaging & Supply:
- Inclusive of sterile lyophilized powders packaged in infusion-compatible plastics, supplied in ready-to-reconstitute formats in multiple international markets.
3. Sagent Pharmaceuticals (Now part of WuXi AppTec)
Overview:
Focuses on the production of sterile injectables, including antibiotics. Sagent has supplied piperacillin-tazobactam in flexible infusion containers.
Product Details:
- Packaging: Infusion bags made of PVC or non-PVC plastics, with formulations suitable for reconstitution into hospital infusion systems.
Supply Focus:
- Sagent's manufacturing facilities are FDA-approved, with emphasis on quality and supply stability for hospital use.
4. Hospira (a Pfizer company)
Overview:
Although predominantly acquired by Pfizer, Hospira has historically been a key supplier of sterile injectables, including antibiotics.
Product Details:
- Previously, Hospira issued piperacillin-tazobactam in plastic infusion containers.
- Currently integrated into Pfizer's supply chain, their legacy manufacturing supports global distribution.
5. Other Regional and Local Suppliers
In emerging markets and certain regions, local pharmaceutical firms manufacture generic versions of Zosyn in plastic containers, often supplied under different brand labels. Regulatory agencies such as the FDA (U.S.) and EMA (Europe) establish strict quality standards for such products.
Manufacturing and Quality Considerations
Regulatory Compliance:
All suppliers must maintain GMP compliance, verified through audits by health authorities like the FDA and EMA. Quality assurance includes validation of sterilization processes, container integrity, and shipment stability.
Container Material Selection:
Plastic containers often utilize PVC or non-PVC alternatives like polyethylene or polypropylene to reduce leaching risks, especially for prolonged infusions. Compatibility studies are essential to preserve drug stability and prevent degradation or contamination.
Supply Chain Dynamics:
The COVID-19 pandemic underscored vulnerabilities in sterile injectable supply chains. Suppliers with diversified manufacturing footprints and robust logistics are prioritized by healthcare providers.
Distribution Channels & Procurement Strategies
Hospital procurement of Zosyn in plastic containers involves navigating multiple vendors, negotiating supply agreements, and ensuring compliance with pharmacovigilance standards. While Pfizer is the primary global supplier, regional generic manufacturers often provide cost-effective alternatives.
Strategic relationships with multiple suppliers mitigate shortages and foster supply chain resilience, especially critical when supply disruptions occur due to manufacturing delays or regulatory issues.
Implications for Healthcare Procurement
Understanding suppliers' capabilities when sourcing Zosyn in plastic containers aids procurement professionals in maintaining uninterrupted antibiotic therapy options. Considerations include verifying regulatory approvals, assessing supply chain reliability, evaluating container material compatibility, and ensuring product stability for hospital storage.
Key Takeaways
- Major global suppliers of Zosyn in plastic containers include Pfizer, Teva, and Sagent Pharmaceuticals, supported by regional manufacturers.
- Packaging primarily involves sterile lyophilized powders in infusion-ready plastic bags, designed for stability and compatibility with hospital infusion systems.
- Manufacturing quality compliance under GMP ensures product safety and efficacy, with container materials selected to minimize leaching and stability issues.
- Supply chain resilience is vital; diversified sourcing strategies mitigate risks of shortages.
- Healthcare procurement must verify regulatory clearance, container compatibility, and supplier reliability for continuous patient care.
FAQs
1. What are the primary packaging types for Zosyn in hospitals?
Zosyn is predominantly supplied as a lyophilized powder in plastic infusion bags, which are reconstituted with sterile water at the point of use for infusion.
2. Which companies are the leading suppliers of Zosyn in plastic containers?
Pfizer is the primary manufacturer, with Teva and Sagent Pharmaceuticals also producing generic versions in suitable plastic packaging.
3. Are non-PVC plastics used for Zosyn infusion bags?
Yes. While PVC is common, non-PVC options like polyethylene or polypropylene are increasingly favored to reduce leaching and compatibility issues.
4. How do supply chain disruptions impact Zosyn availability?
Disruptions can cause shortages, especially during global health crises. Comprehensively diversified suppliers and regional manufacturing help mitigate such risks.
5. What regulatory standards govern the manufacturing of Zosyn in plastic containers?
Manufacturers must adhere to GMP standards enforced by authorities like the FDA and EMA, ensuring sterility, stability, and safe container materials.
References
- Pfizer Inc. Product Information. Zosyn (piperacillin/tazobactam) [Online]. Available at: [Pfizer website]
- U.S. Food and Drug Administration (FDA). Approved drug products with therapeutic equivalents.
- European Medicines Agency (EMA). Zosyn product documentation.
- Sagent Pharmaceuticals. Sterile Injectable Antibiotics Portfolio.
- Teva Pharmaceuticals. Generic Antibiotics Portfolio.
