CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM: Pharmaceutical manufacturers, suppliers, and wholesalers

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The combination of Ceftolozane Sulfate and Tazobactam Sodium has become a significant pharmaceutical solution in combating resistant bacterial infections, notably complicated urinary tract infections, intra-abdominal infections, and pneumonia. These antibiotics are often supplied in fixed-dose combinations to enhance efficacy against multidrug-resistant bacteria, including Pseudomonas aeruginosa and Enterobacteriaceae. Securing reliable suppliers for these active pharmaceutical ingredients (APIs) is crucial for pharmaceutical manufacturers, healthcare providers, and supply chain strategists.

Overview of Ceftolozane Sulfate and Tazobactam Sodium

Ceftolozane Sulfate is a cephalosporin antibiotic with potent activity against multidrug-resistant Gram-negative bacteria.
Tazobactam Sodium is a β-lactamase inhibitor that extends the spectrum of cephalosporins like ceftolozane against resistant bacteria by inhibiting β-lactamase enzymes.
The combination is marketed under the brand name Zerbaxa (by Pfizer) and other formulations, emphasizing the importance of high-quality, consistent API supply chains.

Major API Suppliers for Ceftolozane Sulfate

Shanghai Hach Chemical Co., Ltd.
- Based in China, this company is recognized for manufacturing and supplying ceftolozane sulfate APIs. They offer verified quality standards suitable for global markets, with certifications such as ISO 9001 and GMP compliance.
Lupin Limited
- An Indian pharmaceutical behemoth, Lupin produces a broad portfolio of antibiotics, including ceftolozane sulfate. Their manufacturing facilities adhere to strict cGMP guidelines, making their APIs acceptable on several regulatory jurisdictions.
Qingdao Bioxo Pharmaceutical Co., Ltd.
- Also headquartered in China, Bioxo supplies pharmaceutical APIs, including ceftolozane sulfate, to global manufacturers. Their focus on modern synthesis methods ensures high purity levels and consistent batch quality.
Zhejiang Hisun Pharmaceutical Co., Ltd.
- Chinese-based, with established antimicrobial API manufacturing capabilities, including ceftolozane sulfate. Their APIs conform to international standards, catering mainly to Asian and emerging markets.

Principal Tazobactam Sodium API Suppliers

North China Pharmaceutical Group Corporation (NCPC)
- A leading Chinese pharmaceutical producer, NCPC supplies high-quality tazobactam sodium. Their Tazobactam Sodium APIs meet rigorous pharmacopeial standards, including USFDA and EMA requirements.
Aspen Pharmacare
- South Africa’s Aspen manufactures and markets β-lactamase inhibitors like tazobactam sodium, ensuring a steady supply to developed markets, with quality certifications and compliance with global standards.
Hubei Huida Pharmaceutical Co., Ltd.
- Focused on β-lactam antibiotics and inhibitors, this Chinese company supplies tazobactam sodium APIs that are utilized in various fixed-dose combinations worldwide.
Haryana-based Indian API producers (e.g., Aurobindo Pharma, Dr. Reddy’s Laboratories)
- These companies are developing and supplying tazobactam sodium APIs for generic formulations with cGMP standards, primarily serving North American and European markets.

Global Distribution and Regulatory Considerations

The APIs from these suppliers are typically supplied to pharmaceutical manufacturers who produce the final combination drug formulations. Ensuring regulatory compliance (e.g., FDA, EMA, PMDA) is fundamental for API acceptance, requiring thorough documentation, batch Certificate of Analysis (CoA), and adherence to Good Manufacturing Practices (GMP).

Certifications & Quality Assurance: Major suppliers maintain ISO 9001, ISO 13485, and GMP certifications, vital for FDA and international regulatory approvals.
Manufacturing Locations: Primarily China and India dominate API production for these molecules, with regional suppliers in South Africa and Southeast Asia increasingly contributing to supply volumes.

Emerging Suppliers & Market Trends

As global demand for carbapenem-resistant infection treatments rises, new suppliers are entering the market, particularly in regions pursuing modernization of chemical synthesis and quality standards. Partnerships and licensing agreements facilitate technology transfer and ensure supply chain resilience.

Key trends include:

Increased investments in Chinese and Indian API manufacturing capacity.
Adoption of sustainable and green synthesis methods.
Enhanced regulatory alignment for API exports to Western markets.

Supply Chain and Procurement Strategy

Procurement professionals should prioritize suppliers with:

Proven compliance with international standards.
Transparent quality control processes.
A track record of consistent batch supply.
Flexibility for scale-up in response to market demand.

Thorough supplier qualification processes, including audits and technical evaluations, are imperative to mitigate risks of contamination, supply disruption, or regulatory non-compliance.

Key Players Summary Table

Supplier	Location	Key Products	Certifications	Market Focus
Shanghai Hach Chemical	China	Ceftolozane Sulfate	GMP, ISO 9001	Global, Asia
Lupin Limited	India	Ceftolozane Sulfate	cGMP	Global
Qingdao Bioxo Pharma	China	Ceftolozane Sulfate	GMP	Asia, Emerging Markets
North China Pharma	China	Tazobactam Sodium	cGMP, FDA-ready	Global
Aspen Pharmacare	South Africa	Tazobactam Sodium	GMP	Developing Markets
Aurobindo Pharma	India	Tazobactam Sodium	cGMP	Global

Key Takeaways

Diverse Supplier Base: The primary suppliers for Ceftolozane Sulfate and Tazobactam Sodium are based mainly in China and India, with an expanding presence in Africa and Southeast Asia.
Regulatory Compliance Is Paramount: Suppliers must demonstrate adherence to international standards (GMP, ISO, etc.) to ensure acceptance by major regulatory agencies.
Strategic Procurement: Establishing long-term partnerships with multiple suppliers mitigates risks and secures supply continuity amid global supply chain disruptions.
Quality Control Is Critical: Robust testing and documentation, including Certificates of Analysis, should underpin procurement decisions.
Market Trends Favor Innovative, Green Manufacturing: Future supply chains are likely to favor suppliers adopting environmentally sustainable and efficient synthesis methods.

FAQs

1. Are Chinese API manufacturers reliable for supply of Ceftolozane Sulfate and Tazobactam Sodium?
Yes. Leading Chinese API producers such as Shanghai Hach Chemical and Qingdao Bioxo adhere to international GMP standards and maintain certifications like ISO 9001, ensuring consistent quality for global markets.

2. What are the key regulatory considerations for sourcing these APIs?
Suppliers must demonstrate compliance with cGMP, provide thorough documentation, and hold relevant certifications (FDA, EMA, etc.) to meet regulatory approval benchmarks for finished pharmaceutical products.

3. Can Indian API manufacturers supply these compounds for FDA-approved drugs?
Yes. Indian manufacturers like Lupin and Aurobindo Pharma meet stringent cGMP requirements and have a proven track record supplying APIs for drugs approved by the FDA and other global agencies.

4. How do supply chain disruptions impact the availability of these APIs?
Disruptions in manufacturing or logistics can delay API supply, affecting drug production timelines. Diversifying supplier sources and maintaining safety stock are common strategies to mitigate such impacts.

5. Are emerging markets developing alternative API suppliers for these drugs?
Yes. Emerging markets in Southeast Asia, South America, and Africa are investing in local API production capabilities, aiming to reduce dependence on traditional suppliers and improve supply resilience.

References

[1] Pfizer. Zerbaxa (Ceftolozane and Tazobactam). Product Information.
[2] Chinese State Food and Drug Administration (CFDA). API manufacturing standards.
[3] Indian Pharmaceutical Alliance. API industry reports.
[4] Global Data. Antibiotics Market Report, 2023.
[5] World Health Organization. Good Manufacturing Practices for APIs, 2022.

This analysis aims to guide pharmaceutical leaders, procurement executives, and strategists in navigating the supplier landscape for Ceftolozane Sulfate and Tazobactam Sodium, ensuring supply chain robustness and regulatory compliance.

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