Suppliers and packagers for generic pharmaceutical drug: CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM

CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM

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 of Ceftolozane Sulfate and Tazobactam Sodium

Last updated: February 19, 2026

This report details key suppliers for ceftolozane sulfate and tazobactam sodium, active pharmaceutical ingredients (APIs) used in the combination antibiotic Zerbaxa. Identifying and understanding the supply chain for these critical components is essential for pharmaceutical manufacturers and investors. The landscape includes API manufacturers, contract development and manufacturing organizations (CDMOs), and raw material providers.

What are the Primary Applications of Ceftolozane Sulfate and Tazobactam Sodium?

Ceftolozane sulfate, a cephalosporin antibiotic, and tazobactam sodium, a beta-lactamase inhibitor, are combined to create the broad-spectrum antibiotic marketed as Zerbaxa. This combination targets difficult-to-treat Gram-negative bacterial infections, including multidrug-resistant strains of Pseudomonas aeruginosa and carbapenem-resistant Enterobacteriaceae.

• Ceftolozane Sulfate: This fifth-generation cephalosporin demonstrates activity against a range of Gram-negative pathogens. It inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs).
• Tazobactam Sodium: Tazobactam is a potent inhibitor of beta-lactamase enzymes, which are produced by bacteria to inactivate beta-lactam antibiotics like ceftolozane. By inhibiting these enzymes, tazobactam restores the antibacterial activity of ceftolozane.

The primary therapeutic use for this combination is in the treatment of hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), and complicated intra-abdominal infections (cIAI). It is also indicated for complicated urinary tract infections (cUTI) and the treatment of infections caused by specific Gram-negative aerobic bacteria.

Who are the Key Manufacturers of Ceftolozane Sulfate API?

The manufacturing of complex APIs like ceftolozane sulfate involves specialized chemical synthesis and stringent quality control. Several pharmaceutical ingredient manufacturers and CDMOs are involved in producing this API.

• Merck & Co. (MSD): As the innovator and marketing authorization holder for Zerbaxa, Merck is a primary producer and controller of ceftolozane sulfate API, often through its internal manufacturing capabilities or its contracted network.
• Teva Pharmaceutical Industries Ltd.: Teva, a major generic pharmaceutical company, has demonstrated capabilities in API synthesis for various antibiotic classes. While specific public disclosures for ceftolozane sulfate are limited, its broad API portfolio suggests potential involvement.
• Other Specialized API Manufacturers: The complex multi-step synthesis of ceftolozane sulfate often involves intermediaries from various chemical suppliers. Companies specializing in cephalosporin synthesis or complex organic chemistry are likely participants. These include entities based in China and India, which are major global hubs for API production. Due to intellectual property and commercial sensitivity, specific contract manufacturers are not always publicly disclosed.

Table 1: Potential Ceftolozane Sulfate API Manufacturers and Their Strengths

Manufacturer	Primary Role	Notes
Merck & Co. (MSD)	Innovator, Primary Producer	Controls intellectual property and manufacturing for its branded product.
Teva Pharmaceutical Industries Ltd.	Generic API Manufacturing (Potential)	Extensive API manufacturing experience; may produce for generic versions or through contract manufacturing.
Specialized Chemical Synthesizers	Contract Manufacturing, Intermediates	Focus on complex organic synthesis, often supporting multiple pharmaceutical clients globally.
Asian API Manufacturers (China, India)	Cost-Effective Production	Major global suppliers of intermediates and finished APIs; adherence to international quality standards is critical.

Who are the Key Manufacturers of Tazobactam Sodium API?

Tazobactam sodium, a derivative of penicillin, is another critical component. Its manufacturing requires expertise in beta-lactam chemistry.

• Pfizer Inc.: While Merck markets Zerbaxa, tazobactam is also a component of other widely used antibiotics like Zosyn (piperacillin/tazobactam), for which Pfizer is a key supplier. This extensive experience with tazobactam positions Pfizer as a significant potential or actual supplier for various combinations.
• Centrient Pharmaceuticals: This company is a significant producer of beta-lactam antibiotics and intermediates, including those related to penicillin and cephalosporin derivatives. Their portfolio is well-suited for tazobactam production.
• CordenPharma International: As a CDMO with expertise in complex chemical synthesis, CordenPharma is equipped to manufacture APIs like tazobactam sodium under contract for pharmaceutical companies.
• Indian and Chinese API Manufacturers: Similar to ceftolozane sulfate, a substantial portion of global tazobactam sodium API production is likely concentrated in India and China, driven by cost efficiencies and established chemical manufacturing infrastructure. Companies like Divi's Laboratories and Zhejiang NHU Co., Ltd. are prominent in the broader API manufacturing space and may be involved.

Table 2: Potential Tazobactam Sodium API Manufacturers and Their Strengths

Manufacturer	Primary Role	Notes
Pfizer Inc.	Broad Beta-Lactam Manufacturer	Significant established player in beta-lactam production, including tazobactam for other widely used antibiotics.
Centrient Pharmaceuticals	Beta-Lactam Specialist	Focus on antibiotic APIs and intermediates; strong position in the beta-lactam market segment.
CordenPharma International	Contract Development and Manufacturing (CDMO)	Offers custom synthesis services for complex APIs, including those in the beta-lactam class.
Indian & Chinese API Suppliers	High-Volume, Cost-Effective Production	Key global sources for APIs; manufacturers must comply with stringent global regulatory requirements (e.g., FDA, EMA).

What is the Regulatory Landscape for API Sourcing?

Sourcing APIs for pharmaceutical products requires strict adherence to regulatory guidelines to ensure product safety, efficacy, and quality.

• Good Manufacturing Practices (GMP): All API manufacturers must comply with GMP regulations as defined by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This includes robust quality management systems, process validation, and impurity control.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory authorities. These confidential documents contain detailed information about the manufacturing process, facilities, and quality controls for an API. Pharmaceutical companies referencing a DMF in their drug applications must ensure the DMF is complete and up-to-date.
• Inspections and Audits: Pharmaceutical companies routinely conduct audits of their API suppliers to verify GMP compliance and quality standards. Regulatory agencies also conduct site inspections.
• International Conference on Harmonisation (ICH) Guidelines: ICH guidelines, such as ICH Q7 (GMP Guide for Active Pharmaceutical Ingredients), provide a globally recognized framework for API manufacturing quality.

The sourcing of ceftolozane sulfate and tazobactam sodium APIs is subject to these rigorous requirements. Companies like Merck, in their role as the innovator, maintain strict control over their supply chain and often qualify multiple suppliers to ensure continuity and quality. For generic versions, contract manufacturers must demonstrate equivalent quality and compliance.

What are the Potential Supply Chain Risks and Mitigation Strategies?

The pharmaceutical supply chain for critical APIs like ceftolozane sulfate and tazobactam sodium faces several potential risks.

• Geopolitical Instability: Concentration of manufacturing in specific regions can create vulnerabilities to trade disputes, natural disasters, or political unrest.
• Quality Control Failures: Any lapse in GMP compliance by an API supplier can lead to product recalls, regulatory actions, and significant financial and reputational damage.
• Intellectual Property Issues: For innovator products, strict control over API sourcing is maintained to protect proprietary manufacturing processes and compositions.
• Raw Material Availability: The synthesis of complex molecules depends on the availability of precursor chemicals. Disruptions in the supply of these raw materials can impact API production.
• Capacity Constraints: As demand for effective antibiotics grows, particularly for treating resistant infections, API manufacturing capacity can become a bottleneck.

Table 3: Supply Chain Risks and Mitigation Strategies

Risk Category	Specific Risks	Mitigation Strategies
Geopolitical	Trade barriers, export restrictions, local disruptions	Diversify supplier base across different geographic regions; establish buffer stock of critical raw materials.
Quality	GMP non-compliance, impurity outbreaks	Rigorous supplier qualification and ongoing audits; dual sourcing from highly vetted manufacturers; implement advanced analytical testing at receipt.
Intellectual Property	Unauthorized manufacturing, process breaches	Strict contractual agreements with suppliers; robust IP protection measures within internal operations and with partners.
Raw Material Supply	Shortages of precursors, price volatility	Secure long-term supply contracts for key starting materials; identify and qualify alternative suppliers for critical intermediates; explore backward integration for key precursors.
Capacity	Insufficient manufacturing slots, lead time increases	Proactive capacity planning with key CDMOs; build strong, collaborative relationships with suppliers to ensure priority access; invest in process optimization to improve yields.

What are the Key Considerations for Sourcing Ceftolozane Sulfate and Tazobactam Sodium?

Pharmaceutical companies and investors evaluating the supply chain for ceftolozane sulfate and tazobactam sodium should consider the following factors:

• API Purity and Impurity Profile: Ensuring the API meets stringent pharmacopoeial standards (e.g., USP, EP) and that the impurity profile is well-characterized and controlled is paramount.
• Supplier Reliability and Compliance History: A track record of consistent quality, regulatory compliance, and on-time delivery is critical. This includes a history of successful FDA/EMA inspections.
• Manufacturing Scale and Flexibility: The ability of the supplier to scale production to meet market demand and to adapt to potential changes in formulation or dosage requirements is important.
• Cost Competitiveness: While quality and reliability are primary, cost efficiency is a significant factor, especially for generic drug development or market entry.
• Intellectual Property Landscape: Understanding the patent status of both the final drug product and the API manufacturing processes is crucial to avoid infringement.

The market for antibiotics, particularly those addressing resistant pathogens, is vital. Securing reliable and high-quality sources for ceftolozane sulfate and tazobactam sodium is a strategic imperative for companies operating in this space.

Key Takeaways

• Ceftolozane sulfate and tazobactam sodium are critical APIs for the broad-spectrum antibiotic Zerbaxa, targeting difficult Gram-negative infections.
• Merck & Co. (MSD) is the innovator and a primary producer, while other major API manufacturers and CDMOs, particularly in India and China, are potential or actual suppliers for both APIs.
• Pfizer Inc. and Centrient Pharmaceuticals are notable players in tazobactam sodium manufacturing due to their established beta-lactam expertise.
• API sourcing is governed by stringent GMP regulations, requiring adherence to FDA and EMA standards, and often involves the use of Drug Master Files (DMFs).
• Supply chain risks include geopolitical instability, quality control failures, IP issues, raw material shortages, and capacity constraints, necessitating robust mitigation strategies such as supplier diversification and rigorous audits.
• Key sourcing considerations include API purity, supplier reliability, manufacturing scalability, cost competitiveness, and the intellectual property landscape.

Frequently Asked Questions

1. What are the main regulatory bodies that oversee API manufacturing for ceftolozane sulfate and tazobactam sodium? The primary regulatory bodies are the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Other national health authorities also play a role depending on the target markets.
2. How does the innovator company (Merck) typically manage its API supply chain for Zerbaxa? Innovator companies often maintain proprietary manufacturing or work with a select group of qualified contract manufacturers under strict agreements to protect intellectual property and ensure quality and supply chain integrity.
3. What is the significance of a Drug Master File (DMF) in the context of sourcing these APIs? A DMF provides confidential, detailed information about the manufacturing process, facilities, and quality controls of an API to regulatory agencies. Pharmaceutical companies can reference an approved DMF in their drug applications, streamlining the regulatory review process.
4. Are there significant price differences between APIs sourced from different geographic regions? Yes, APIs sourced from regions like China and India are often more cost-competitive due to lower labor and manufacturing overheads compared to those produced in North America or Europe. However, total cost of ownership must consider logistics, quality assurance, and regulatory compliance.
5. What steps should a generic drug manufacturer take when identifying potential API suppliers for ceftolozane sulfate and tazobactam sodium? Generic manufacturers must identify suppliers who can demonstrate equivalent API quality, purity, and manufacturing processes to the innovator. This involves thorough due diligence, including site audits, review of DMFs, and confirmation of GMP compliance, to ensure bioequivalence and regulatory approval.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Guidance for Industry: ANDA Submissions—Refuse-to-Receive Criteria. Retrieved from [FDA website] [2] European Medicines Agency. (n.d.). Good manufacturing practice. Retrieved from [EMA website] [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (1998). ICH Harmonised Tripartite Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7. Retrieved from [ICH website] [4] Merck & Co., Inc. (n.d.). Zerbaxa (ceftolozane and tazobactam) Prescribing Information. Retrieved from [Merck website] [5] Various public company reports and industry analyses regarding API manufacturing capabilities in India and China. (Specific report titles vary).