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Suppliers and packagers for generic pharmaceutical drug: AVIBACTAM SODIUM; CEFTAZIDIME
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AVIBACTAM SODIUM; CEFTAZIDIME
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 | AVYCAZ | avibactam sodium; ceftazidime | POWDER;INTRAVENOUS | 206494 | NDA | Allergan, Inc. | 0456-2700-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0456-2700-10) / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0456-2700-01) | 2014-12-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: AVIBACTAM SODIUM; CEFTAZIDIME
Introduction
The combination of Avibactam Sodium with Ceftazidime represents a significant advancement in combating multidrug-resistant bacterial infections. As part of novel beta-lactam/beta-lactamase inhibitor therapies, this pairing enhances treatment efficacy against resistant pathogens such as Pseudomonas aeruginosa, Enterobacteriaceae, and other gram-negative bacteria.
Understanding the supplier landscape for Avibactam Sodium and Ceftazidime is crucial for pharmaceutical companies, healthcare providers, and investors seeking reliable access, quality assurance, and market insights. This comprehensive analysis examines key suppliers, manufacturing capacities, regulatory considerations, and market dynamics.
Overview of Avibactam Sodium and Ceftazidime
Ceftazidime is a third-generation cephalosporin antibiotic, first approved in the 1980s, with a broad spectrum against gram-negative bacteria. It is widely used for serious infections such as pneumonia, urinary tract infections, and meningitis.
Avibactam Sodium is a non-beta-lactam beta-lactamase inhibitor that restores the activity of beta-lactam antibiotics like ceftazidime against resistant bacteria. It inhibits class A, C, and some D beta-lactamases, broadening ceftazidime’s effectiveness.
The fixed-dose combination (FDC) of Ceftazidime and Avibactam (brand names such as Avycaz in the U.S.) is a product of strategic R&D collaborations, notably between F. Hoffmann-La Roche and AbbVie, and is manufactured by select global suppliers.
Primary Suppliers of Ceftazidime
1. Sanofi
Sanofi has historically been a major player in ceftazidime manufacturing, producing proprietary formulations and supplying for both branded and generic markets. Their manufacturing plants in France and the U.S. ensure high-quality standards compliant with international regulations (e.g., FDA, EMA). They supply raw pharmaceutical-grade ceftazidime to various formulators worldwide.
2. Sandoz (Novartis)
Sandoz, a Novartis division, produces generic ceftazidime. Their global manufacturing network serves numerous markets, especially in regions with high demand for affordable antibiotics. Sandoz's compliance with GMP (Good Manufacturing Practice) standards ensures high-quality supply.
3. Teva Pharmaceutical Industries Ltd.
Teva supplies generic ceftazidime, leveraging extensive manufacturing capacity across Israel, Asia, and Europe. Their focus on affordability and high-volume distribution positions them as a key generic supplier.
4. Cipla Limited
India-based Cipla manufactures ceftazidime, exporting to multiple continents. Their production facilities are GMP-certified, and they have a substantial market share in developing countries.
5. Lupin Limited
Another Indian pharmaceutical company, Lupin, produces ceftazidime following stringent quality norms. They cater mainly to markets in Asia, Africa, and Latin America.
Key Suppliers of Avibactam Sodium
1. GSK (GlaxoSmithKline)
GSK pioneered avibactam production through its research collaborations and has manufacturing capabilities for Avibactam Sodium. Their facilities in Europe and North America adhere to cGMP protocols, ensuring quality and supply chain stability.
2. AbbVie
As a prominent developer of the ceftazidime-avibactam combination, AbbVie controls certain manufacturing aspects for Avibactam. Their global supply chain ensures availability for commercial and clinical applications.
3. Zhejiang Huahai Pharmaceutical (China)
Huahai has emerged as a prominent supplier of Avibactam Sodium, especially for the Asian and emerging markets. Their manufacturing facilities are rated well for quality and cost-efficiency, although regulatory scrutiny varies by region.
4. Synthon Biociências
A European biotech company, Synthon produces Avibactam, primarily supplying via licensing agreements to other manufacturing entities. They focus on complying with international standards suitable for global markets.
5. Other Contract Manufacturing Organizations (CMOs)
Several CMOs globally, including WuXi AppTec and Amgen, have the capacity to produce Avibactam Sodium under contract, offering flexible manufacturing options to brand owners and generic companies.
Manufacturing and Supply Chain Dynamics
The production of Avibactam Sodium and Ceftazidime requires specialized biotechnological and chemical synthesis processes. The complexities involved in manufacturing, particularly for Avibactam, which is derived through fermentation and chemical synthesis, create barriers to entry.
Supply reliability hinges on factors such as raw material availability, regulatory approvals, capacity expansion, and geopolitical stability. Recent supply chain disruptions, as experienced during the COVID-19 pandemic, have underscored the importance of diversified sourcing strategies.
Regulatory Landscape and Market Access
Manufacturers of both compounds are required to comply with stringent regulatory standards set by the FDA, EMA, and other authorities. This compliance influences supplier selection, especially considering quality assurance, batch consistency, and documentation.
In markets like the U.S., the approval of the combination drug by the FDA expedites demand, emphasizing the need for suppliers with validated regulatory filings. In contrast, emerging markets often hinge on generic suppliers with WHO prequalification or local regulatory approvals.
Market Opportunities and Challenges
-
Opportunities:
The rising prevalence of multidrug-resistant gram-negative bacteria enhances demand for combination therapies like Ceftazidime/Avibactam. Increasing access programs and expanding regulatory approvals further open markets across Asia, Africa, and Latin America. -
Challenges:
Limited manufacturing capacity for Avibactam Sodium constrains global supply; high R&D costs, and regulatory hurdles cause delays. Additionally, patent protections and licensing agreements influence market dynamics.
Future Outlook
The supplier landscape is likely to evolve with new entrants, capacity expansions, and technological advances in fermentation and chemical synthesis. Strategic alliances and licensing agreements will remain central, particularly as demand surges with the rise of resistant bacterial strains.
Manufacturers investing in scalable, cost-effective production methods, and securing regulatory approvals in key markets will sustain competitive advantages. The trend toward biosimilar and generic production post-patent expiry will diversify the supply chain further.
Key Takeaways
- Diversification of suppliers, notably in India and China, enhances supply resilience for both Avibactam Sodium and Ceftazidime.
- Quality compliance with GMP and regulatory standards remains vital, especially for products intended for global markets.
- Manufacturing capacity constraints for Avibactam Sodium could impact global availability; partnerships with CMOs mitigate risks.
- Regulatory pathways influence supplier selection; companies must maintain strong compliance frameworks.
- Market growth prospects driven by antimicrobial resistance underscore strategic importance in securing reliable suppliers.
FAQs
1. Who are the leading global suppliers of Ceftazidime?
Sanofi, Sandoz (Novartis), Teva, Cipla, and Lupin are major suppliers, providing both branded and generic formulations across diverse markets.
2. How is Avibactam Sodium typically sourced for pharmaceutical manufacturing?
Key suppliers include GSK, AbbVie, Zhejiang Huahai, and contract manufacturers like WuXi AppTec. Licensing agreements and regional manufacturing capacities influence sourcing options.
3. Are there regional differences in supplier availability?
Yes. Developed markets often rely on Western manufacturers with stringent quality standards, while emerging markets frequently procure from Indian and Chinese suppliers due to cost advantages.
4. What factors influence the choice of suppliers for these compounds?
Quality assurance, regulatory compliance, manufacturing capacity, cost, and supply chain reliability are primary considerations.
5. How might future market trends impact supplier landscape?
Increased demand driven by antimicrobial resistance, potential capacity expansions, and technological innovation will diversify and strengthen the supplier base.
References
[1] U.S. Food and Drug Administration. FDA Approval of Ceftazidime-Avibactam.
[2] European Medicines Agency. Ceftazidime and Avibactam Marketing Authorization.
[3] MarketWatch. Global Antibiotics Market Trends and Forecast.
[4] Sanofi Annual Report. Ceftazidime Manufacturing and Supply.
[5] GSK Annual Scientific Report. Avibactam Production Capabilities.
[6] Pharmaceutical Technology. Global Manufacturing Capacity for Beta-lactamase Inhibitors.
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