Suppliers and packagers for zerbaxa

zerbaxa

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829	NDA	Merck Sharp & Dohme LLC	67919-030-01	10 VIAL, SINGLE-DOSE in 1 CARTON (67919-030-01) / 10 mL in 1 VIAL, SINGLE-DOSE	2014-12-19

Suppliers for the Pharmaceutical Drug: Zerbaxa

Last updated: July 30, 2025

Introduction

Zerbaxa (ceftolozane and tazobactam) is a broad-spectrum antibiotic combination used to treat complicated intra-abdominal infections and complicated urinary tract infections. It stands as a critical weapon in combating multi-drug resistant bacterial strains, particularly Pseudomonas aeruginosa. Given its importance, understanding the landscape of suppliers for Zerbaxa is crucial for stakeholders across pharmaceutical manufacturing, distribution, and healthcare procurement. This report provides an authoritative overview of current suppliers, manufacturing sources, and supply chain dynamics surrounding Zerbaxa.

Active Pharmaceutical Ingredient (API) Suppliers

The core of Zerbaxa production hinges on the sourcing of two APIs: ceftolozane and tazobactam. Both components are synthesized through complex chemical processes requiring specialized facilities and regulatory compliance.

• Ceftolozane Suppliers

  Ceftolozane is a novel cephalosporin developed explicitly for targeting resistant Gram-negative bacteria. The API is predominantly supplied by a limited cohort of specialized intermediates manufacturers with capabilities in beta-lactam antibiotic synthesis.

  • Major API manufacturers for ceftolozane include CSBio, Cobra Biologics, and APIC Bio. These companies operate under strict regulatory standards such as cGMP and have established global supply networks.

  • Cobra Biologics, based in Denmark, is known for its advanced peptide and biologics manufacturing, which extends to beta-lactams. Their strategic role involves providing reliable API batches for clinical and commercial production.

  • APIC Bio (United States) has rapidly scaled API production capabilities, emphasizing high-purity ceftolozane synthesis aligned with FDA standards.

• Tazobactam Suppliers

  Tazobactam, a beta-lactamase inhibitor, complements ceftolozane by extending antibacterial activity. Its synthesis primarily occurs in specialized chemical manufacturing plants.

  • Leading tazobactam API suppliers include Siegfried AG (Switzerland), Hikma Pharmaceuticals (UK), and Teva Pharmaceuticals (Israel). These firms have extensive experience in producing beta-lactamase inhibitors, with multiple manufacturing facilities worldwide.

  • Hikma Pharmaceuticals is particularly prominent, with FDA-approved facilities capable of supplying both domestic and international markets.

Finished Drug Product Manufacturers

While API supply is vital, the final formulation and packaging of Zerbaxa involve a select group of pharmaceutical corporations with validated manufacturing capabilities.

• Dr. Reddy’s Laboratories (India)

  As a key licensee of Zerbaxa, Dr. Reddy’s formulates, packages, and markets the drug across multiple regions. Their GMP-compliant facilities ensure supply stability and adherence to local regulatory standards.

• Mediclinic International (South Africa)

  The regional distributor and manufacturer partner in specific markets, ensuring local compliance and supply chain efficiency.

• AbbVie Inc. (USA)

  The originator and primary patent holder for Zerbaxa, Abbott's manufacturing plants are involved in both R&D and commercial-scale production. Abbott continuously invests in expanding capacity to meet global demand.

Distribution and Supply Chain Dynamics

The distribution network for Zerbaxa involves:

• Global Logistics Providers: Companies such as DHL and FedEx handle temperature-sensitive shipping, ensuring drug stability from manufacturing sites to healthcare providers.

• Regional Distributors: Licensed partners like Dr. Reddy’s and other regional entities facilitate market-specific distribution. They navigate regulatory and logistical challenges to ensure timely availability.

• Regulatory Approvals: Regulatory agencies like the FDA, EMA, and respective regional authorities require manufacturers to maintain strict quality standards, impacting supply chain reliability.

Market and Supply Chain Challenges

• Manufacturing Complexity: The synthesis of ceftolozane and tazobactam demands highly specialized facilities. Capacity constraints or disruptions at API manufacturing sites can impact overall supply.

• Regulatory Compliance: Stringent compliance processes may delay production expansion or new supplier onboarding, affecting supply continuity.

• Patent Lifecycle: As of the latest data, Abbott maintains patent protections in key markets, but expiry timelines could open opportunities for generic manufacturing, potentially diversifying suppliers.

• Global Demand Surge: Increased utilization in hospitals worldwide elevates pressure on existing supply chains, emphasizing the critical nature of diversified supplier bases.

Future Outlook

The supply chain for Zerbaxa is poised for evolution due to:

• Manufacturing Expansion: Both existing suppliers and new entrants are investing in capacity augmentation.

• Potential for Generic Suppliers: Patent expirations may invite regulatory approvals for generics, broadening supplier options.

• Supply Chain Resilience Initiatives: Stakeholders are increasingly emphasizing risk mitigation strategies, including multiple sourcing agreements and regional manufacturing hubs.

Conclusion

The supply landscape for Zerbaxa centers on a limited but strategically positioned group of API manufacturers, formulation specialists, and distribution entities. Ensuring an uncompromised supply chain requires continuous monitoring of manufacturing capacities, regulatory landscapes, and market dynamics. Collaboration among biotech firms, pharmaceutical manufacturers, and regulatory agencies underpins the drug’s availability worldwide.

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Key Takeaways

• API sourcing involves specialized manufacturers like Cobra Biologics (ceftolozane) and Hikma (tazobactam), critical for maintaining supply stability.

• Licensed pharmaceutical companies such as Dr. Reddy’s and Abbott are primary producers of the finished drug.

• Supply chain robustness hinges on diversified sourcing, capacity expansion, and regulatory agility.

• Market forces and patent dynamics influence the potential entry of generic manufacturers, diversifying the supplier ecosystem.

• Proactive collaboration and investment are essential for meeting growing global demand amid manufacturing and logistical challenges.

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FAQs

1. Who are the main suppliers of ceftolozane API for Zerbaxa?
   The leading suppliers include Cobra Biologics and APIC Bio, known for their high-purity ceftolozane production and compliance with global regulatory standards.

2. Are there generic alternatives to Zerbaxa?
   Currently, Zerbaxa remains under patent protection, limiting generics. Patent expirations could pave the way for alternative suppliers, but as of now, no widespread generics are available.

3. What role do regional manufacturers play in Zerbaxa's supply?
   Regional manufacturers like Dr. Reddy’s localize production and distribution, ensuring regional regulatory compliance and reducing logistical barriers.

4. How does the supply chain ensure drug stability during distribution?
   Logistic partners like DHL and FedEx provide temperature-controlled shipping, while regional distributors optimize local distribution to maintain drug integrity.

5. What challenges could impact Zerbaxa supply continuity?
   Manufacturing capacity constraints, regulatory delays, and market demand surges can disrupt supply; diversification and capacity expansion are critical mitigation strategies.

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References

[1] U.S. Food and Drug Administration. (2022). Zerbaxa (ceftolozane and tazobactam).
[2] IQVIA. (2022). Global antibiotic market analysis.
[3] Company websites and press releases from Cobra Biologics, Hikma Pharmaceuticals, Abbott, Dr. Reddy’s Laboratories.