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

Comprehensive Analysis of Suppliers for Ceftolozane Sulfate and Tazobactam Sodium

Last updated: April 24, 2025

The combination of ceftolozane sulfate and tazobactam sodium, marketed under the brand name Zerbaxa, represents a critical therapeutic option for combating multidrug-resistant bacterial infections. This report provides a detailed examination of the supply chain, manufacturing landscape, and key suppliers involved in the production and distribution of this antibiotic combination.

---

Pharmaceutical Overview of Ceftolozane/Tazobactam

Ceftolozane is a fifth-generation cephalosporin antibiotic with enhanced activity against Pseudomonas aeruginosa, while tazobactam, a beta-lactamase inhibitor, extends its efficacy against organisms producing certain resistance enzymes[5][15]. The combination, approved by the FDA in 2014, is indicated for complicated intra-abdominal infections, urinary tract infections, and hospital-acquired pneumonia[5][15]. Merck Sharp & Dohme (MSD), following its acquisition of Cubist Pharmaceuticals, holds the primary intellectual property and manufacturing rights for Zerbaxa[7][13].

---

Finished Product Suppliers: Zerbaxa Distribution Network

As the sole manufacturer of the finished product, Merck Sharp & Dohme distributes Zerbaxa globally through authorized pharmaceutical distributors. Key distributors include:

• Cardinal Health (Order Code: 5045810)
• McKesson Corporation (Order Code: 3971686)
• Cencora (Order Code: 10237721)[9].

These distributors ensure cold-chain compliance, given the product’s requirement for refrigeration[1][4]. Despite Merck’s exclusivity in formulation, a 2022 shortage highlighted vulnerabilities in sterile manufacturing processes, underscoring the need for robust quality control[11].

---

Active Pharmaceutical Ingredient (API) Manufacturers

The APIs for Zerbaxa—ceftolozane sulfate and tazobactam sodium—are synthesized by specialized manufacturers, often under contract with Merck. Independent suppliers also produce these compounds for generic markets in regions where patents have expired.

Ceftolozane Sulfate Suppliers

1. Jinan Tantu Chemicals (China): Offers custom synthesis services with certifications including USDMF and ISO[2][12].
2. ACS Dobfar Spa (Italy): A leading European API producer with compliance to EU-GMP standards[2].
3. Molcore (China): Specializes in cephalosporin intermediates, supplying to generic drugmakers[3][17].

Tazobactam Sodium Suppliers

1. Sinoway Industrial Co. (China): Provides GMP-certified tazobactam for injectable formulations[16].
2. Otsuka Chemical (Japan): Known for high-purity beta-lactamase inhibitors[16].
3. Zhejiang Hisun Pharma (China): Supplies bulk tazobactam to emerging markets[16].

These suppliers operate under stringent regulatory frameworks, with certifications such as CEP and WHO prequalification ensuring global acceptance[2][16].

---

Regional Supply Dynamics

North America

Merck’s U.S. facilities dominate production, with secondary API sourcing from Jinan Tantu and Molcore to meet demand[1][11]. Distributors like McKesson and Besse Medical manage logistics, leveraging cold-chain infrastructure[9].

Asia-Pacific

In India, GNH India and Iskon Remedies act as secondary distributors for Merck, though local API production by Orchid Pharma and Qilu Tianhe supports generic formulations in prequalified markets[14][18].

Europe

Cencora and DMS Pharmaceutical Group facilitate distribution, while ACS Dobfar ensures API supply continuity under EU regulatory oversight[9][16].

---

Supply Chain Challenges and Mitigation

The 2022 shortage of Zerbaxa, attributed to sterility issues at Merck’s plant, revealed systemic risks in single-source dependency[11]. To mitigate future disruptions, Merck has diversified API sourcing and invested in modular manufacturing technologies[6][11]. Additionally, partnerships with generic manufacturers like GMT Pharma International aim to enhance capacity in underserved regions[18].

---

Future Outlook and Strategic Recommendations

1. Expansion of API Suppliers: Encouraging entry of manufacturers in regions like India and China could stabilize supply chains.
2. Cold-Chain Innovation: Adoption of blockchain for real-time temperature monitoring during transit[14].
3. Patent Expiry Preparations: With Zerbaxa’s composition patent expiring in 2030, generic manufacturers are poised to enter markets, necessitating preemptive quality alignment[15].

---

Key Takeaways

• Merck Sharp & Dohme remains the primary supplier of Zerbaxa, with a robust distributor network ensuring global access.
• API production is decentralized, with key players in China, Italy, and Japan supporting both branded and generic markets.
• Supply chain resilience requires strategic partnerships and regulatory collaboration to prevent shortages.

---

FAQs

1. Is Zerbaxa available as a generic drug?
   No, Zerbaxa remains under patent protection until 2030, though APIs are available for investigational use[15][18].

2. Which distributors handle Zerbaxa in the U.S.?
   Cardinal Health, McKesson, and Cencora are primary distributors[9].

3. How does Merck ensure API quality?
   Suppliers must comply with USDMF and EU-GMP standards, subject to FDA audits[2][16].

4. What caused the 2022 Zerbaxa shortage?
   Sterility issues at Merck’s manufacturing facility disrupted production[11].

5. Are there alternative suppliers for tazobactam sodium?
   Yes, including Sinoway Industrial and Otsuka Chemical[16].

---

“The combination of ceftolozane and tazobactam represents a significant advancement in tackling resistant Gram-negative infections, with supply chain strategies evolving to meet global demand.” — *DrugBank Online[15]*

References

1. https://mms.mckesson.com/product/1015050/Schering-Plough-67919003001
2. https://www.pharmacompass.com/manufacturers-suppliers-exporters/ceftolozane
3. https://pharmaoffer.com/api-excipient-supplier/ceftolozane
4. https://www.slimedical.com/zerbaxa-ceftolozane-tazobactam-preservative-free-1-5-gram-injection-vial-67919003001.html
5. https://www.drugs.com/history/zerbaxa.html
6. https://adisinsight.springer.com/drugs/800031484
7. https://pmc.ncbi.nlm.nih.gov/articles/PMC4461093/
8. http://www.actlifesciences.com/zerbaxa-ceftolozane-and-tazobactam.html
9. https://www.merckconnect.com/zerbaxa/ordering/
10. https://go.drugbank.com/salts/DBSALT001488
11. https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=705
12. https://www.pharmacompass.com/manufacturers-suppliers-exporters/zerbaxa
13. https://www.drugdiscoverynews.com/cubist-obtains-remaining-rights-for-ceftolozane-from-astellas-7158
14. https://www.gnhindia.com/products/us-ndc/ceftolozane-and-tazobactam-zerbaxa-67919-030/
15. https://go.drugbank.com/drugs/DB09050
16. https://pharmaoffer.com/api-excipient-supplier/antibacterials/tazobactam
17. https://www.pharmacompass.com/manufacturers-suppliers-distributors-services-api/ceftolozane-sulfate
18. https://www.gmtpharmainternational.com/product/gucef-tz-562-50/