Last updated: August 5, 2025
Introduction
Brevibloc (esmolol hydrochloride) is an ultra-short-acting beta-1 selective adrenergic antagonist predominantly used in acute settings such as intraoperative and postoperative hypertension, arrhythmias, and cardiac surgery. The drug's demand, particularly in critical care, has driven its manufacturing and supply chain development, emphasizing high-quality production and reliable distribution. This analysis evaluates the key suppliers for Brevibloc double strength in plastic containers, considering global manufacturing footprints, regulatory compliance, and market dynamics.
Overview of Brevibloc and Its Formulation
Brevibloc (esmolol hydrochloride) is marketed primarily by AstraZeneca, with formulations available in various strengths, including double strength. The double-strength formulation is typically packaged in plastic containers—commonly polypropylene infusion bags or bottles—to ensure stability, ease of use, and reduced medication volume per dose.
This formulation's specifics:
- Strength: Double strength (e.g., 100 mg/mL)
- Container Type: Plastic infusion bags or bottles (PVC or alternative materials)
- Usage: Intravenous administration in hospitals
The manufacturing and supply chain of Brevibloc double strength involve several pharmaceutical suppliers, primarily those compliant with regulatory standards such as FDA, EMA, and other regional authorities.
Key Manufacturers of Brevibloc Double Strength in Plastic Containers
1. AstraZeneca – Original Manufacturer and Proprietary Producer
AstraZeneca is the originator and primary supplier of Brevibloc globally. Its manufacturing plants, located chiefly in the United States and Europe, produce both the active pharmaceutical ingredient (API) and the finished dosage forms, including plastic container versions. AstraZeneca maintains strict quality control standards, ensuring product stability and regulatory compliance.
Distribution: AstraZeneca supplies Brevibloc through direct channels, authorized distributors, and regional headquarters. Their global footprint ensures availability across major markets.
Regulatory Status: The company holds multiple approvals, including FDA and EMA authorizations, which validate the quality of their sterile preparations in plastic containers.
2. Contract Manufacturing Organizations (CMOs)
Given the competitive landscape and global demand, several CMOs manufacture Brevibloc under licensing agreements or contractual arrangements, often focusing on the sterile fill-finish process:
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Fresenius Kabi
A leading manufacturer specializing in sterile infusion solutions, Fresenius Kabi produces similar high-quality beta-blocker infusions and has the capacity to produce Brevibloc in plastic containers. They emphasize compliance with the US Pharmacopeia (USP), European Pharmacopoeia, and other standards.
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Baxter International
Known for its extensive portfolio of infusion products, Baxter supplies comparable formulations and may serve as an alternative or authorized provider for Brevibloc in certain regions. Their facilities in North America and Europe are certified for sterile manufacturing and plastic container filling.
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Pfizer and Teva Pharmaceutical Industries
Both companies have capabilities in sterile injection manufacturing and may partner with AstraZeneca or produce biosimilar or generic versions under licensing or after patent expiry.
3. Generic Manufacturers and Market Entry Players
With patent expiration or licensing agreements, several generic manufacturers have entered the market, offering Brevibloc in plastic containers, often at lower costs:
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Lepine Pharma
A Canadian-based manufacturer offering sterile infusion preparations, including beta-blocker infusions, with respective FDA and Health Canada approvals.
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Qilu Pharmaceutical
A Chinese pharmaceutical enterprise with growing sterility manufacturing capabilities, producing generic injectable formulations for global markets.
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Hangzhou Bioke
Focused on sterile pharmaceuticals, China-based manufacturers like Hangzhou Bioke have developed formulations compatible with plastic containers.
Note: These manufacturers often operate under stringent regulatory oversight and may supply to regional markets rather than globally.
Global Supply Chain and Regional Variability
The supply landscape for Brevibloc double strength in plastic containers varies significantly across regions:
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North America: Dominated by AstraZeneca and Baxter, with extensive distribution networks supporting hospitals and infusion centers.
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Europe: Primarily supplied by AstraZeneca and licensed CMOs with CE marking and EMA approvals.
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Asia-Pacific: Growing number of local manufacturers, such as Qilu and Bioke, expanding access and reducing dependence on Western suppliers.
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Emerging Markets: Often rely on regional generic or local manufacturers, with regulatory approval processes influencing vendor choice.
Regulatory Considerations and Quality Assurance
Suppliers must adhere to Good Manufacturing Practice (GMP) standards and obtain necessary approvals from relevant authorities. Certification documentation, stability data, and bioequivalence studies are critical components.
Key points:
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GMP compliance is mandatory for all manufacturers supplying sterile injections.
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Container compatibility: Plastic containers must meet USP or European Pharmacopoeia standards to prevent leaching, ensure stability, and maintain drug efficacy.
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Regulatory registration: Countries demanding strict approval processes may restrict Brevibloc supplies to certain vendors, influencing supplier selection.
Market Dynamics and Future Trends
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Patent expiry: The original patent for Brevibloc has expired in many jurisdictions, catalyzing the entry of generics and alternative suppliers.
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Manufacturing capacity expansion: To meet rising demand, manufacturers are investing in new sterile filling lines, especially in Asia-Pacific regions.
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Supply chain resilience: Recent global disruptions underscore the importance of diversified supplier bases and regional manufacturing hubs.
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Innovative container materials: Advances in container technology, such as polypropylene or multilayer systems, improve stability and reduce leaching risks.
Conclusion
The supply of Brevibloc double strength in plastic containers involves a combination of original manufacturer AstraZeneca and numerous CMOs, generic producers, and regional suppliers. AstraZeneca remains the principal vendor, ensuring high-quality formulations with global reach. However, regional manufacturing capacity, patent status, and regulatory environments shape the availability of alternative suppliers. As the market evolves, heightened emphasis on quality, regulatory compliance, and resilient supply chains will influence supplier choices for healthcare providers and distributors.
Key Takeaways
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Primary Supplier: AstraZeneca leads global supply, supported by certified CMOs like Fresenius Kabi, Baxter, and generic manufacturers.
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Manufacturing Trends: Contract manufacturing and generic entrants expand options, especially in emerging markets.
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Regulatory Impact: Vendor quality and approvals are critical to maintaining supply integrity across regions.
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Market Dynamics: Patent expirations and regional manufacturing capabilities foster increased competition and supply diversification.
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Future Outlook: Emphasis on innovative container materials and supply chain resilience will shape market offerings.
FAQs
1. Who is the main manufacturer of Brevibloc double strength in plastic containers?
AstraZeneca is the original and primary manufacturer, with several approved contract manufacturers and generic producers supplying regional markets.
2. Are there alternatives to AstraZeneca for Brevibloc supply?
Yes, several CMOs and generic companies, such as Fresenius Kabi, Baxter, and regional manufacturers, produce Brevibloc under licensing agreements or as generics, especially post-patent expiry.
3. What are critical factors influencing supplier selection for Brevibloc in plastic containers?
Regulatory approval, manufacturing quality, container compatibility, supply capacity, and regional compliance are key factors.
4. How does patent status impact supply options?
Patent expiration facilitates entry by generics, increasing competition, reducing costs, and expanding supply options in various regions.
5. What future trends could affect the supply chain of Brevibloc?
Advancements in container materials, supply chain diversification, increased manufacturing capacity in emerging markets, and regulatory developments will influence future supply dynamics.
Sources
[1] AstraZeneca product documentation and global regulatory filings.
[2] European Medicines Agency database.
[3] FDA Orange Book.
[4] Industry reports on sterile injectable manufacturing capacities.
[5] Market analysis articles on generic pharmaceutical manufacturing trends.
