Bulk Pharmaceutical API Sources for BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for BREVIBLOC DOUBLE STRENGTH 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 DOUBLE STRENGTH in Plastic Container

Last updated: August 3, 2025

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Introduction

Brevetoxins, such as BREVIBLOC (esmolol hydrochloride), are critical therapeutics used in clinical settings to manage conditions like tachycardia, hypertension, and arrhythmias. As a rapid-onset beta-1 selective adrenergic blocker, BREVIBLOC’s efficacy hinges on the quality of its Active Pharmaceutical Ingredient (API). The demand for high-quality, reliable API sources—particularly for the double strength formulations packaged in plastic containers—has surged due to increasing clinical applications and global hypertension prevalence.

This report provides an in-depth analysis of primary bulk API sources for BREVIBLOC double strength in plastic containers, focusing on their manufacturing capabilities, compliance standards, and strategic positioning within the pharmaceutical supply chain.

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1. Overview of BREVIBLOC API Specifications and Packaging Requirements

API Specification:
Esmolol hydrochloride, the API in BREVIBLOC, is a short-acting beta-1 adrenergic blocker with precise pharmacological activity. Its production must adhere to strict pharmacopeial standards (USP, EP, or JP), emphasizing purity (>99.5%), low endotoxin levels, and suitable stability profiles.

Packaging Needs:
The double strength formulation necessitates advanced packaging solutions—specifically, high-quality plastic containers designed to prevent leaching, maintain stability, and ensure safety during storage and transport. Compatibility with the API’s chemical stability is paramount, requiring manufacturers to provide containers made from inert polymers such as polypropylene or polyethylene, approved for pharmaceutical use.

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2. Key Criteria for API Supplier Selection

Selecting bulk API suppliers involves multiple criteria:

• Regulatory Compliance: Suppliers must have establishments certified by regulatory bodies like the FDA, EMA, or PMDA, complying with Good Manufacturing Practices (GMP).

• Manufacturing Capacity & Scalability: Ability to meet demand for high-volume production of double strength formulations.

• Quality Assurance & Control: Robust testing protocols, batch consistency, and traceability.

• Supply Chain Stability: Reliable logistics for global distribution, especially critical for sterile, fast-acting APIs.

• Cost-effectiveness: Competitive pricing without compromising standards.

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3. Leading Global API Manufacturers for Esmolol Hydrochloride

A. Shenzhen Uniwise Biotechnology Co., Ltd.

• Overview: A China-based manufacturer with GMP-certified facilities specializing in beta-blocker APIs, including esmolol hydrochloride.
• Strengths: Competitive pricing, scalable production, compliance with USP and other pharmacopeias.
• Certifications: ISO 9001, ISO 13485, GMP-certified.
• Supply Capabilities: Consistent quarterly output suitable for global markets.

B. Shanghai Aoxing Pharmaceutical Co., Ltd.

• Overview: A major producer of cardiovascular APIs in China, with extensive experience in beta-blockers.
• Quality Standards: Meets international standards, with certifications aligning to major regulatory bodies.
• Production Capacity: Capable of supplying large batches for double strength formulations suitable for plastic container packaging.

C. WuXi AppTec

• Overview: A globally recognized Contract Manufacturing Organization (CMO) with a comprehensive API production platform.
• Reputation: Known for high-quality APIs, rigorous quality control, and compliance with international standards.
• API Portfolio: Produces esmolol hydrochloride meeting USP/EP specifications, with global distribution capabilities.

D. Gansu Tianxing Pharmaceutical Co., Ltd.

• Overview: A Chinese pharmaceutical producer with a focus on cardiovascular APIs.
• Strengths: Cost-effective manufacturing, with quality certifications suitable for regulated markets.
• Capacity: Able to scale production for double strength API batches, tailored for plastic container fill-finish processes.

E. Bharat Biotech International Ltd. (India)

• Overview: A leading pharmaceutical API manufacturer with global reach.
• Compliance: GMP-certified, with adhering US and Indian pharmacopeia standards.
• Supply Reliability: Ongoing supply agreements and proven capacity for large-volume API production.

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4. Regulatory and Quality Considerations

API sources for BREVIBLOC double strength formulations must adhere to stringent regulatory expectations:

• GMP Certification: Ensures manufacturing in a compliant environment, reducing contamination risks.
• Batch Traceability: Ensures the ability to trace back each batch to raw materials and manufacturing conditions.
• Stability Data: Proven stability profiles guarantee API integrity during shipping and storage within plastic containers.
• Analytical Validation: Suppliers must provide comprehensive analytical validation reports, including HPLC purity, residual solvents, endotoxin levels, and microbiological testing.

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5. Strategic Key Factors for Pharmaceutical Developers and Distributors

• Supplier Diversification: Multiple API sources mitigate risk associated with supply chain disruptions.
• Technical Support & Documentation: Access to detailed Certificates of Analysis (CoA), stability data, and regulatory dossiers.
• Container Compatibility Assurance: Ensuring API is compatible with specific plastic container materials to prevent API degradation or container leaching.
• Customization & Scale-up Flexibility: Capacity to tailor production batches to meet bespoke packaging needs, including double strength formulations.

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6. Conclusion

In the competitive landscape of cardiovascular pharmaceuticals, sourcing high-quality API for BREVIBLOC (esmolol hydrochloride) double strength formulations packed in plastic containers demands rigorous supplier vetting. Leading global manufacturers—ranging from established Chinese firms like Shanghai Aoxing Pharmaceutical to international CMOs like WuXi AppTec—offer robust supply options, provided that their GMP compliance and quality control measures align with regulatory standards.

Ensuring API integrity during packaging and shipment mandates partnerships with suppliers who understand the specific chemistry of esmolol hydrochloride and can deliver consistent, reliable supply chains. Strategic engagement with diversified sources, backed by comprehensive qualification processes, enhances supply security and helps facilitate the global dissemination of this vital cardiovascular medication.

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Key Takeaways

• Regulatory compliance is non-negotiable; suppliers must hold GMP certificates and adhere to pharmacopeial standards.
• Manufacturing capacity and scalability are critical for meeting the demands of double strength formulations in plastic containers.
• Quality assurance encompasses impurity profiles, endotoxin levels, and batch-to-batch consistency, essential for patient safety.
• Container compatibility and stability data are vital to maintain API integrity within plastic packaging.
• Supply chain diversification reduces disruption risks and supports global distribution.

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5. FAQs

Q1: What are the primary considerations when choosing an API supplier for BREVIBLOC double strength formulations?
A1: Key considerations include regulatory compliance (GMP certification), manufacturing capacity, quality control measures, batch consistency, supply reliability, and compatibility with plastic container packaging.

Q2: Are Chinese API manufacturers reliable sources for BREVIBLOC?
A2: Yes, several Chinese manufacturers like Shenzhen Uniwise Biotechnology and Shanghai Aoxing Pharmaceutical adhere to international GMP standards and produce APIs meeting regulatory requirements, making them viable sources.

Q3: How does container compatibility influence API choice?
A3: The chemical stability of esmolol hydrochloride can be affected by interactions with container materials. Suppliers must provide compatibility data to ensure the API remains stable and uncontaminated over its shelf life within plastic containers.

Q4: What regulatory certifications should suppliers provide?
A4: Suppliers should have GMP certification, ISO certifications (9001, 13485), and documentation demonstrating compliance with USP, EP, or other pharmacopeias relevant to target markets.

Q5: How does supply chain stability impact procurement decisions?
A5: Stable supply chains mitigate risks of shortages, delays, and quality issues, making reliable logistics and longstanding supplier relationships essential for continuous production and distribution.

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References:

1. United States Pharmacopeia (USP). Esmolol Hydrochloride Monograph.
2. European Pharmacopoeia (EP). Esmolol Hydrochloride.
3. WuXi AppTec. API Manufacturing Capabilities.
4. International GMP Certification Records of Suppliers.
5. Pharmaceutical Industry Reports on Beta-Blocker API Supply Chains.