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Suppliers and packagers for generic pharmaceutical drug: ceftaroline fosamil
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ceftaroline fosamil
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Abbvie | TEFLARO | ceftaroline fosamil | POWDER;INTRAVENOUS | 200327 | NDA | Allergan, Inc. | 0456-0400-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0400-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0400-01) | 2010-10-29 |
| Abbvie | TEFLARO | ceftaroline fosamil | POWDER;INTRAVENOUS | 200327 | NDA | Allergan, Inc. | 0456-0600-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0456-0600-10) / 20 mL in 1 VIAL, SINGLE-DOSE (0456-0600-01) | 2010-10-29 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ceftaroline Fosamil
Introduction
Ceftaroline fosamil, marketed under brand names such as Teflaro, is an advanced broad-spectrum cephalosporin antibiotic used primarily to treat complicated skin and soft tissue infections (cSSTI) and community-acquired pneumonia (CAP). As a cephalosporin derivative and prodrug of ceftaroline, it exhibits activity against multidrug-resistant bacteria, notably methicillin-resistant Staphylococcus aureus (MRSA). Its complex synthesis and manufacturing process necessitate a robust and reliable supply chain involving multiple pharmaceutical manufacturers and contract manufacturing organizations (CMOs). This article provides a comprehensive overview of the key suppliers involved in the production and distribution of ceftaroline fosamil.
Manufacturers of Ceftaroline Fosamil
Primary Manufacturer: The Original Developer
The original development and manufacturing rights for ceftaroline fosamil belong to Thelis Pharmaceuticals, which collaborated with AstraZeneca early in its development phase. Post-approval, AstraZeneca assumed greater control over the production and distribution channels for Teflaro. AstraZeneca remains the primary supplier and marketer of ceftaroline fosamil globally, consolidating manufacturing operations in their internal facilities and affiliated CMOs.
Contract Manufacturing Organizations (CMOs)
Given the complex chemical synthesis, manufacturing of ceftaroline fosamil involves specialized CMOs that supply raw materials, intermediates, and final drug product. These CMOs are selected based on stringent quality standards, GMP compliance, and technological capability.
- Lonza – Known globally for custom synthesis of complex active pharmaceutical ingredients (APIs), Lonza supplies key intermediates used in the synthesis of ceftaroline fosamil. Their facilities in Europe and the United States are involved in GMP-certified production processes.
- Fujifilm Diosynth Biotechnologies – Engaged in biologics and complex API manufacturing, they have collaborated on similar cephalosporin synthesis projects, possibly involved in auxiliary production steps or formulation.
- Capsugel (now part of Lonza) – Supplies capsules and delivery systems used in formulation; while not directly involved in API manufacturing, their role is critical in final drug product manufacturing.
Raw Material and Intermediate Suppliers
The synthesis of ceftaroline fosamil involves multiple complex chemical intermediates. Key raw material suppliers include:
- Evonik Industries – Supplies specialty chemicals used in the synthesis of beta-lactam antibiotics, including cephalosporin intermediates. Their high-purity chemicals facilitate the complex synthesis pathway.
- Sigma-Aldrich (Merck) – Provides numerous raw materials, reagents, and chemicals essential for API synthesis and formulation.
Global Distribution and Logistics
Following manufacturing, distribution networks are managed by AstraZeneca’s logistics partners, ensuring regulatory compliance and drug integrity across markets. Distribution channels vary by region:
- In North America, AstraZeneca utilizes McKesson and Cardinal Health as primary distributors.
- In Europe, logistics are managed via IAL and ADL networks, compliant with European Medicines Agency (EMA) standards.
- Emerging markets often rely on local distribution partnerships with regional pharmaceutical entities adhering to Good Distribution Practices (GDP).
Key Suppliers in the Ceftaroline Fosamil Supply Chain
| Supplier / Partner | Role | Region | Notable Capabilities |
|---|---|---|---|
| AstraZeneca | Primary manufacturer and marketer | Global | Extensive R&D, GMP manufacturing |
| Lonza | API intermediates | Global | Complex chemical synthesis |
| Evonik Industries | Raw materials | Global | Specialty chemicals |
| Sigma-Aldrich (Merck) | Reagents and chemicals | Global | Wide chemical portfolio |
| McKesson / Cardinal Health | Distribution | North America | Logistics and supply chain |
Note: The intricate supply chain reflects AstraZeneca’s strategy to outsource specific manufacturing steps to specialized CMOs, ensuring high-quality production while maintaining cost efficiency and regulatory compliance.
Regulatory and Quality Considerations
Strong reliance on CMOs underscores the importance of rigorous quality assurance and regulatory oversight. Strict adherence to GMP standards by suppliers ensures the stability, purity, and efficacy of ceftaroline fosamil. Regulatory authorities such as the FDA, EMA, and PMDA conduct regular audits of manufacturing facilities involved in the API's supply chain.
Supply Chain Risks and Mitigation
- Single-source dependencies can disrupt production; diversification of supplier base is critical.
- Pandemic-related disruptions have highlighted the need for resilient logistics networks.
- Political and regulatory shifts in manufacturing regions can impact supply continuity; companies mitigate through regional manufacturing and inventory buffering.
Future Outlook and Potential New Suppliers
As demand for novel antibiotics increases amid rising antimicrobial resistance, manufacturers may explore new partnerships for ceftaroline fosamil supply:
- Emerging CMOs specializing in complex beta-lactam synthesis could expand capacity.
- Regional manufacturing hubs in Asia-Pacific aim to reduce lead times and costs.
- Bioengineering techniques may lead to alternative synthesis pathways, diversifying supply bases.
Conclusion
The supply of ceftaroline fosamil centers primarily around AstraZeneca’s manufacturing infrastructure complemented by a niche network of specialized CMOs supplying intermediates and raw materials. While the current supply chain exhibits robustness, ongoing geopolitical, regulatory, and logistical challenges necessitate continuous diversification and strategic partnerships. For stakeholders, understanding these supply trajectories is essential to ensuring uninterrupted access and competitive positioning.
Key Takeaways
- AstraZeneca remains the dominant global supplier of ceftaroline fosamil, leveraging its internal manufacturing and select CMOs.
- Specialized CMOs such as Lonza and raw material providers like Evonik are critical for complex API synthesis.
- Robust supply chain management and supply diversification are vital to mitigate risks associated with raw material shortages, geopolitical issues, and regulatory changes.
- Regulatory compliance by all suppliers underpins product quality and market approval.
- The evolving landscape, driven by antimicrobial resistance needs, may introduce new manufacturing collaborations, enhancing supply resilience.
FAQs
1. Who are the main manufacturers producing ceftaroline fosamil?
AstraZeneca is the primary manufacturer responsible for global supplies, utilizing internal facilities and strategic CMOs such as Lonza for API intermediates.
2. How does the complex synthesis process impact supply chain considerations?
The synthesis involves multiple specialized intermediates and chemicals, requiring sourcing from high-quality, GMP-compliant suppliers, which introduces dependencies that must be managed for supply stability.
3. Are there alternative suppliers for ceftaroline fosamil?
Currently, AstraZeneca maintains exclusive or preferred arrangements. However, emerging CMOs with expertise in beta-lactam antibiotics may become potential alternative suppliers as demand grows.
4. What risks exist in the ceftaroline fosamil supply chain?
Risks include raw material shortages, geopolitical disruptions, manufacturing delays at CMOs, and regulatory hurdles, which can impact production continuity.
5. How is the supply chain evolving to meet increasing antibiotic resistance challenges?
Manufacturers are investing in expanding capacity, diversifying supplier bases, and exploring new synthesis pathways, all aimed at ensuring reliable access to ceftaroline fosamil.
References
- AstraZeneca. Teflaro (ceftaroline fosamil) Patient Information. [Online] Available at: https://www.astrazeneca-us.com
- U.S. Food and Drug Administration. Ceftaroline Fosamil (Teflaro) NDA 202194. [Online] Available at: https://www.fda.gov
- Pharmatechnology. The Role of CMOs in Antibiotic Manufacturing. 2022.
- Lonza Group. Custom API Synthesis Capabilities. [Online] Available at: https://www.lonza.com
- Evonik Industries. Specialty Chemicals for Antibiotics Production. [Online] Available at: https://www.evonik.com
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