Last updated: July 31, 2025
Introduction
Brevicloc, known generically as esmolol, is a short-acting β1-selective adrenergic blocker primarily used for rapid control of heart rate in acute settings such as hypertensive emergencies and intraoperative hypertension. Its administration in plastic containers—typically via infusion bags—necessitates a streamlined supply chain comprising reliable raw material sources, manufacturing partners, and distribution channels. This article provides an in-depth analysis of the key suppliers involved in the production and distribution of Brevibloc in plastic containers, emphasizing the current market landscape, regulatory considerations, and strategic sourcing insights for pharmaceutical stakeholders.
Market Overview of Brevibloc in Plastic Containers
The global demand for esmolol—especially in the context of critical care and emergency medicine—has escalated over recent years. The shift towards ready-to-administer formulations, packaged in sterile plastic containers for ease of use and safety, underscores the importance of a resilient supply chain. Major pharmaceutical companies, including AstraZeneca, which originally developed and marketed Brevibloc, have delegated manufacturing responsibilities to specialized contract manufacturing organizations (CMOs) and maintained strategic supplier relationships for raw materials like esmolol hydrochloride.
Primary Raw Material Suppliers
The foundational component of Brevibloc—esmolol hydrochloride—is synthesized through complex pharmaceutical chemical processes. The critical raw materials include:
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Esmolol Base and Hydrochloride Salt:
Leading suppliers such as Sigma-Aldrich, Thermo Fisher Scientific, and SMG Chemicals provide high-purity esmolol intermediates and active pharmaceutical ingredients (APIs). These organizations supply to largeContract Manufacturing Organizations (CMOs) capable of scaling production for sterile injectable formulations.
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Excipients and Stabilizers:
Components such as sodium chloride, sterile water for injection, and buffering agents are supplied by BASF, Dow Chemical, and Merck KGaA. These are required to prepare the infusion solution, ensuring stability and compatibility within plastic infusion bags.
Contract Manufacturers and Packagers
Manufacturing of Brevibloc in plastic containers predominantly involves specialized CMOs with sterile fill-finish capabilities:
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Hikma Pharmaceuticals:
A key player in sterile APIs and finished injectable products, Hikma supplies esmolol solutions in plastic infusion bags to several hospital systems worldwide.
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CordenPharma:
A leading CMO providing sterile filling, leaching, and packaging services, with extensive capabilities in flexible bag and container format production.
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Vaccine and Drug Manufacturing Facilities (e.g., Catalent, Siegfried, and Recipharm):
These companies have the infrastructure necessary for high-quality aseptic production, offering custom formulation, sterilization, and distribution services for Brevibloc.
Distribution and Supply Chain Considerations
Distribution of Brevibloc in plastic containers involves:
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Global Distributors:
Companies like Medline Industries, Cardinal Health, and McKesson distribute sterile injectable drugs—including Essmolol—across hospital systems, pharmacies, and clinics.
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Regulatory Compliance and Certification:
Regulatory agencies such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency) require certified manufacturing protocols, lot traceability, and batch qualification. Suppliers maintaining cGMP compliance are prioritized.
Key Suppliers by Region
United States
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Hikma Pharmaceuticals:
An established supplier of sterile injectables, including Brevibloc, with extensive distribution networks within North America.
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Pfizer:
Historically, a manufacturer and marketer of esmolol; some formulations are available via licensed generic partners.
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Bristol-Myers Squibb:
Provides supply chain support and distribution in the US market.
Europe
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Siegfried AG:
Supplies APIs and finished dosage forms, including packaged sterile solutions.
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Recipharm:
Highly regarded for aseptic filling and packaging, supporting regional markets.
Asia-Pacific
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Shandong Weigao Group:
Engaged in manufacturing and distributing infusion containers and connected drug products.
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Jiangsu Nhwa Pharmaceutical Co., Ltd.:
Specializes in sterile preparation and supply of injectable drugs within China.
Regulatory and Quality Certifications
Suppliers must adhere to rigorous regulatory standards:
- FDA cGMP Certification (U.S.)
- EMA Good Manufacturing Practice (GMP) Standards (Europe)
- ISO 13485 and ISO 9001 Certifications for quality management systems.
Manufacturers and suppliers with these certificates are preferable to ensure safety, efficacy, and post-market support.
Strategic Sourcing Insights for Stakeholders
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Diversify Supplier Base:
To mitigate supply risks, pharmaceutical firms should engage multiple qualified suppliers for API and finished products.
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Establish Long-term Partnerships:
Collaborations with CMOs possessing extensive sterile manufacturing capabilities enable reliable supply and quality control.
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Monitor Regulatory Changes:
Supply chain strategies should adapt in response to evolving regulations, including serialization and traceability mandates.
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Invest in Supply Chain Transparency:
Traceability of raw materials through blockchain or ERP systems enhances compliance and quality assurance.
Conclusion
The supply chain for Brevibloc in plastic containers comprises a complex ecosystem of raw material suppliers, contract manufacturing organizations, and distributors. Leading API providers like Sigma-Aldrich and SMG Chemicals supply high-quality esmolol hydrochloride, while CMOs such as Hikma, CordenPharma, and Siegfried handle sterile formulation and packaging. Regional variations influence supplier choices, but regulatory compliance remains paramount across markets. Stakeholders must adopt diversified, transparent, and compliant sourcing strategies to ensure consistent supply in a competitive and highly regulated environment.
Key Takeaways
- The core of Brevibloc supply lies in high-purity esmolol hydrochloride, sourced from reputable chemical suppliers with strict quality standards.
- Contract manufacturers with specialized aseptic and sterile fill-finish facilities play a critical role in transforming APIs into ready-to-use infusion bags.
- Distributors such as Medline and Cardinal Health facilitate global distribution, emphasizing the importance of robust logistics.
- Regional suppliers and manufacturers adapt to local regulatory environments, influencing sourcing decisions.
- Strategic partnerships, regulatory vigilance, and supply chain diversification are essential for resilience in the Brevibloc supply ecosystem.
Frequently Asked Questions
1. Who are the leading API suppliers for Brevibloc?
Major API providers include Sigma-Aldrich, SMG Chemicals, and other specialized chemical manufacturing firms that produce high-grade esmolol hydrochloride.
2. Are there generic equivalents of Brevibloc in plastic containers?
Yes, several generic manufacturers produce esmolol formulations packaged in plastic infusion bags, subject to regional regulatory approvals.
3. What regulatory standards govern the production of Brevibloc?
Manufacturers must adhere to cGMP standards set by agencies like the FDA and EMA to ensure safety and efficacy.
4. How does the supply chain ensure the quality of sterile containers used for Brevibloc?
Suppliers of infusion bags comply with ISO 13485 standards and undergo rigorous sterilization and quality testing processes.
5. What are the major risks in the Brevibloc supply chain?
Risks include raw material shortages, manufacturing disruptions, regulatory delays, and logistical issues—necessitating proactive risk management strategies.
Sources
[1] AstraZeneca. "Esmolol Hydrochloride (Brevibloc) Product Information," AstraZeneca Documentation, 2022.
[2] Sigma-Aldrich. "Esmolol Hydrochloride API Details," Sigma-Aldrich Chemical Suppliers, 2023.
[3] U.S. Food and Drug Administration. "cGMP Regulations," FDA, 2023.
[4] CordenPharma. "Sterile Injectable Manufacturing Capabilities," Corporate Overview, 2023.
[5] Recipharm. " sterile filling and packaging services," Recipharm Annual Report, 2022.
