Bulk Pharmaceutical API Sources for BREVIBLOC IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for BREVIBLOC IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-847-093
Hangzhou APIChem Technology		AC-6972
Oakwood Products		068021
Amadis Chemical		A840055

Bulk Active Pharmaceutical Ingredient (API) Sources for BREVIBLOC in Plastic Container

Last updated: July 30, 2025

Introduction

Breivibloc (Esmolol hydrochloride) is a short-acting β1-selective adrenergic blocker used primarily in acute settings to manage tachyarrhythmias, hypertension, and perioperative hypertension. Its rapid onset and short half-life necessitate precise pharmaceutical handling, often requiring packaging in plastic containers for stability and ease of administration. Ensuring the supply of high-quality bulk API for Brevibloc in suitable packaging is crucial for pharmaceutical manufacturers and healthcare providers. This analysis examines the global sources of Esmolol hydrochloride API, focusing on suppliers capable of providing bulk quantities for formulation into plastic containers, considering regulatory compliance, quality standards, and supply reliability.

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Global API Manufacturing Landscape

The API supply chain has undergone significant globalization, with major manufacturing hubs located primarily in China, India, and Europe. These regions host facilities capable of producing high-quality pharmaceuticals, including specialized β-blockers like Esmolol hydrochloride.

Key API Manufacturers for Esmolol Hydrochloride

1. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

   A leading Chinese API and finished pharmaceutical products manufacturer, Zhejiang Hisun supplies various β-blockers, including Esmolol hydrochloride. The company adheres to strict GMP standards aligned with WHO and Chinese regulatory agencies. Their capacity includes large-scale production of APIs suitable for injectable and oral dosage forms, with consistent quality controls critical for hospital and sterile manufacturing environments.

2. CP Guojian Pharmaceutical (China)

   Recognized for producing high-quality APIs, CP Guojian offers Esmolol hydrochloride with verified GMP certification. Their manufacturing facilities emphasize purity, stability, and batch-to-batch consistency, essential for APIs intended for plastic container formulations in clinical settings.

3. Mikro Labs (India)

   Mikro Labs specializes in cardiovascular API production, including β-blockers like Esmolol hydrochloride. The firm complies with WHO-GMP and US FDA regulations, capable of supplying bulk API for sterile and non-sterile packaging, including plastics suitable for hospital use.

4. Lupin Limited (India)

   A major Indian pharmaceutical manufacturer, Lupin offers bulk APIs with extensive regulatory approvals, including the US FDA and EMA. Its API manufacturing facilities are certified GMP-compliant, providing reliable sources for large-volume API procurement.

5. Cadila Healthcare (India)

   Known for high-quality pharmaceutical APIs, Cadila's manufacturing plants produce Esmolol hydrochloride conforming to stringent international standards. The company serves global markets, including formulations requiring plastic container packaging.

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Regulatory and Quality Considerations

When sourcing bulk APIs for formulations like Brevibloc in plastic containers, manufacturers must prioritize compliance with regulatory standards, such as:

• Good Manufacturing Practice (GMP) certification.
• Pharmacopoeial standards (USP, EP, BP) for purity, potency, and stability.
• Regulatory approvals in target markets, including FDA, EMA, and local agencies.
• Certificate of Analysis (CoA) and raw material traceability to ensure batch consistency.

High-quality APIs should demonstrate low impurity levels, high API purity (typically ≥ 99%), and robust stability profiles that correspond with the intended storage conditions in plastic containers.

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Sourcing Strategies

Global Suppliers and Distributors:

• Authorized Distributors: Connecting with authorized, licensed pharmaceutical distributors ensures compliance and supply certainty.
• APIs Sourced via Contract Manufacturing Organizations (CMOs): CMOs can provision bulk API tailored to specific formulations, including those in plastic containers, and ensure batch consistency.
• International Trade Platforms: Platforms such as Pharmacompass, Sigma-Aldrich, and via authorized channels can connect buyers with verified API suppliers.

Risks to Consider:

• Supply Chain Disruptions: Especially pertinent amid geopolitical tensions and pandemic-related constraints.
• Regulatory Variance: Suppliers must meet regional standards, and imported APIs may require additional testing and validation.
• Pricing Variability: Bulk API prices fluctuate based on global demand, production capacity, and regulatory compliance.

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Packaging Considerations for API Handling

Given that Brevibloc's formulation involves sensitive APIs, sourcing suppliers should provide APIs compatible with packaging in plastic containers without compromising stability or bioavailability. Suppliers experienced with APIs destined for injectable products offer APIs with suitable physiochemical properties, minimal leaching risk, and validated stability in common plastics like PET or polypropylene.

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Leading Suppliers for Brevibloc API in Plastic-Ready Packaging

While the API is usually supplied in bulk powder or granules, the choice of supplier often depends on downstream formulation needs, with some offering APIs pre-qualified for packaging in plastics suitable for medical use:

• Sigma-Aldrich (Merck): Offers high-purity Esmolol hydrochloride APIs along with extensive documentation, facilitating formulation scalability.
• Alfa Aesar (Thermo Fisher Scientific): Supplies pharmaceutical-grade APIs, supporting formulation into plastic containers.
• Carbogen Labs: Specializes in custom API production with validated packaging options.
• Local and regional API manufacturers: Often capable of fulfilling volume needs with compliance tailored to local regulations.

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Future Trends and Considerations

The API market for cardiovascular drugs like Esmolol hydrochloride is expected to stabilize with increasing production capacity in India and China. The growing emphasis on supply chain resilience and quality assurance in the pharmaceutical industry underscores the importance of establishing long-term partnerships with trusted API manufacturers. Enhanced quality standards, such as strict adherence to ICH guidelines and improved traceability, are becoming prerequisites for sourcing APIs intended for sterile and plastic container formulations.

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Key Takeaways

• Major API producers include China (Zhejiang Hisun, CP Guojian) and India (Mikro Labs, Lupin, Cadila), offering compliant, high-quality Esmolol hydrochloride APIs.
• Regulatory compliance (GMP, pharmacopeia standards) and consistent quality are essential prerequisites for API procurement for Brevibloc in plastic containers.
• Partnering with verified distributors or CMOs can streamline supply, ensure quality, and facilitate customization for packaging in plastics suited for sterile, medical applications.
• Supply risks necessitate diversification across multiple qualified suppliers and adherence to strict validation protocols.
• Ongoing market developments emphasize the importance of supply chain resilience and quality assurance in sourcing APIs for critical care medications like Brevibloc.

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FAQs

1. What are the primary challenges in sourcing API for Brevibloc in plastic containers?
   Ensuring API purity, regulatory compliance, consistent supply, and compatibility with plastic packaging materials are primary challenges.

2. Which regions dominate the API manufacturing of Esmolol hydrochloride?
   China and India dominate, with growing contributions from European manufacturers adhering to strict GMP standards.

3. How does API quality influence the safety and efficacy of Brevibloc formulations?
   High-quality APIs with minimal impurities and high stability ensure therapeutic efficacy, reduce adverse reactions, and meet regulatory requirements.

4. What documentation should buyers verify before sourcing the API?
   Certificates of Analysis (CoA), GMP certification, stability data, purity profiles, and compliance with pharmacopeial standards.

5. Are there suppliers offering APIs with pre-qualified packaging options?
   Yes, some suppliers provide APIs pre-qualified for use in specific packaging formats, including plastics suitable for hospital and clinical applications.

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References

[1] Pharmacompass. Global API Suppliers for Cardiovascular Drugs.
[2] USP Monographs and Pharmacopoeias for Esmolol Hydrochloride.
[3] WHO GMP Guidelines for Pharmaceutical Manufacturing.
[4] Market reports on API manufacturing capacities—Indian and Chinese pharmaceutical sectors.