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Suppliers and packagers for generic pharmaceutical drug: ceftobiprole medocaril sodium
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ceftobiprole medocaril 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 |
|---|---|---|---|---|---|---|---|---|---|
| Istx | ZEVTERA | ceftobiprole medocaril sodium | POWDER;INTRAVENOUS | 218275 | NDA | La Jolla Pharmaceutical Company | 68547-578-10 | 10 VIAL, GLASS in 1 BOX (68547-578-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (68547-578-01) | 2025-04-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: CEFTOBIPROLE MEDOCARIL SODIUM
Introduction
Ceftobiprole Medocaril Sodium is a broad-spectrum cephalosporin antibiotic, primarily indicated for the treatment of complicated skin and soft tissue infections (cSSTIs) and certain types of pneumonia such as hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP). Its innovative mechanism of action and efficacy against resistant bacterial strains have positioned it as a significant asset in antimicrobial therapy. The sourcing and supply chain network for ceftobiprole Medocaril Sodium is complex, involving multiple stakeholders globally. Understanding the landscape of suppliers is critical for healthcare providers, pharmaceutical companies, and investors to ensure a stable supply and compliance with regulations.
Manufacturers and Development Stage
1. Cephalosporin Producers and Contract Development Organizations (CDOs)
The manufacturing of ceftobiprole Medocaril Sodium predominantly involves major pharmaceutical companies with advanced biopharmaceutical capabilities. Several key players are engaged either through direct production or contract manufacturing arrangements (CMO).
- Basel-based Basilea Pharmaceutica AG: As the original developer of ceftobiprole, Basilea holds the rights in various jurisdictions and has been pivotal in its clinical development and regulatory approvals. While Basilea primarily acts as a licensor and marketer, it collaborates with manufacturing partners for supply. Its manufacturing agreements are typically with CMO entities specializing in sterile, complex injectables.
- UCB Pharma: UCB has historically collaborated with Basilea, especially for certain markets, and has been involved in the commercialization efforts. UCB’s manufacturing network includes internal facilities and external CMOs, primarily located in Europe and North America.
2. Contract Manufacturing Organizations (CMOs)
Given the complex synthesis and sterile production processes for ceftobiprole Medocaril Sodium, many pharmaceutical companies outsource manufacturing:
- Lonza Group: Based in Switzerland, Lonza is a leading CMO specializing in biologics and complex small molecules, including cephalosporins. The company has the necessary infrastructure to produce sterile injectable antibiotics at scale, conforming to Good Manufacturing Practices (GMP).
- Catalent Pharma Solutions: With extensive experience in sterile injectables, Catalent supplies manufacturing and formulation services that could be applied to ceftobiprole production if contracted.
- Fujifilm Diosynth Biotechnologies: Although more active in biologics, Fujifilm’s facilities are equipped to handle complex small-molecule therapies and may serve as a manufacturing partner.
3. Key Raw Material Suppliers
Supply chain stability depends also on raw material availability, especially the chemical intermediates and reagents used in ceftobiprole synthesis.
- Specialty chemical suppliers, such as:
- Sigma-Aldrich/Merck KGaA: Provides high-purity reagents utilized in the synthesis of cephalosporin compounds. Often supplies raw materials directly to manufacturers or CMO sites.
- Alfa Aesar and Thermo Fisher Scientific: Offer a similar spectrum of chemical intermediates suitable for ceftobiprole synthesis.
Regulatory and Geographical Supply Dynamics
4. Regulatory Approvals and Geographic Distribution
- United States: Ceftobiprole received FDA approval in 2014 under the brand name Zevtera for the treatment of hospital-acquired pneumonia. Eli Lilly was initially involved, but licensing rights shifted, with Basilea assuming commercialization in some regions.
- Europe: Approved by the European Medicines Agency (EMA) for specific indications, with Basilea as the primary license holder.
- Other markets: Licensing and supply depend on regional agreements with local distributors and manufacturers.
5. Supply Challenges and Risks
Supply stability can be threatened by:
- Manufacturing disruptions at CMO facilities or raw material shortages.
- Regulatory delays or compliance issues.
- Limited number of manufacturing sites for sterile antibiotics, leading to potential bottlenecks.
Market Players and Competitive Landscape
While Basilea remains the key innovator and licensor, the global supply chain includes several contract manufacturers that secure the drug’s production at various stages. The reliance on CMOs from regions with stringent GMP standards, such as Europe and North America, ensures quality but also heightens vulnerability to geopolitical and logistical disruptions.
Conclusion
The supply of Ceftobiprole Medocaril Sodium hinges on a handful of specialized pharmaceutical manufacturers and contract organizations. Basilea Pharmaceutica AG remains central as the patent and licensing holder, with manufacturing largely outsourced to CMOs like Lonza and others with sterile injectable expertise. Raw material procurement from leading chemical suppliers further influences supply security.
Ensuring a resilient supply chain requires diversified manufacturing partnerships, robust quality assurance, and strategic raw material sourcing. The complexity of synthesis, regulatory compliance, and global distribution highlights the importance of close monitoring of the supply network to mitigate risks effectively.
Key Takeaways
- Major developers: Basilea Pharmaceutica AG is the principal innovator and licensor, with manufacturing reliance on CMOs like Lonza and Catalent.
- Contract manufacturing: Most production is outsourced due to complex synthesis and sterilization requirements.
- Raw materials: Suppliers such as Sigma-Aldrich and Thermo Fisher provide essential intermediates, impacting supply stability.
- Regulatory landscape: Approvals in key markets (US, Europe) shape manufacturing and distribution strategies.
- Supply risks: Concentration of manufacturing sites, raw material dependency, and geopolitical factors threaten supply continuity.
FAQs
1. Who are the primary manufacturers of Ceftobiprole Medocaril Sodium?
The primary manufacturers are contract organizations such as Lonza Group and Catalent, working under licensing agreements with Basilea Pharmaceutica AG.
2. What raw materials are used in the synthesis of ceftobiprole?
Key intermediates include various cephalosporin precursors and specialty chemicals supplied by firms like Sigma-Aldrich and Alfa Aesar.
3. Are there regional differences in supply sources?
Yes, manufacturing and raw material sourcing vary across regions, with Europe and North America hosting most CMO facilities, influencing regional supply chains.
4. What challenges affect the manufacturing of ceftobiprole?
Challenges include complex sterile synthesis, strict regulatory compliance, raw material shortages, and geopolitical risks.
5. How can supply chain risks for ceftobiprole production be mitigated?
Diversification of manufacturing sites, securing raw material supply agreements, and maintaining regulatory compliance are essential strategies.
Sources:
[1] Baselian Pharmaceutica AG. Ceftobiprole Development and Licensing.
[2] UCB Pharma Collaboration Reports.
[3] Lonza Group Manufacturing Capabilities.
[4] Regulatory Approvals for Ceftobiprole in US and Europe.
[5] Chemical Suppliers for Cephalosporin Intermediates.
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