ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hq Spclt Pharma	ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	SOLUTION;INTRAVENOUS	205703	NDA	WG Critical Care, LLC	44567-811-10	10 BAG in 1 CARTON (44567-811-10) / 250 mL in 1 BAG	2017-12-04
Hq Spclt Pharma	ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER	esmolol hydrochloride	SOLUTION;INTRAVENOUS	205703	NDA	WG Critical Care, LLC	44567-812-10	10 BAG in 1 CARTON (44567-812-10) / 100 mL in 1 BAG	2017-12-04
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

Esmolol hydrochloride is an ultra-short-acting β1-selective adrenergic blocker predominantly used in critical care settings for rapid, short-term management of supraventricular tachycardia, hypertension, and intraoperative tachyarrhythmias. Its fast onset and brief duration necessitate precise formulation and reliable supply chains, especially when provided in double-strength formulations in plastic containers for intravenous administration. This article examines current suppliers specializing in esmolol hydrochloride double strength formulations, focusing on their manufacturing capabilities, quality standards, and procurement considerations relevant to healthcare providers and pharmaceutical distributors.

Market Overview and Demand Dynamics

The global demand for esmolol hydrochloride has grown steadily, driven by increasing awareness of arrhythmia management and expanding intensive care units worldwide. The shift towards ready-to-use, pre-filled, and stable formulations has prompted suppliers to develop double-strength solutions housed in plastic containers for ease of administration and enhanced safety. These formulations typically contain 100 mg/mL of esmolol hydrochloride, double the common strength of 50 mg/mL, offering reduced infusion volume and streamlined dosing.

Key Suppliers of Esmolol Hydrochloride Double Strength in Plastic Containers

1. Bachem AG

Overview: Bachem AG, headquartered in Switzerland, is a leading manufacturer of specialty peptides and active pharmaceutical ingredients (APIs). The company has diversified its portfolio to include cardiovascular APIs like esmolol hydrochloride.

Capabilities and Offerings:

Produces high-purity esmolol hydrochloride API suitable for formulation development.
Supplies finished drug products in various packaging, including flexible plastic containers for IV solutions.
Emphasizes compliance with cGMP standards, ISO certifications, and thorough quality control.

Market Position: Known for robust supply chains and reliable delivery, Bachem serves markets across Europe, North America, and Asia, fulfilling both bulk API and finished pharmaceutical needs.

2. Jiangsu Hengrui Medicine Co., Ltd.

Overview: China-based Jiangsu Hengrui is a major pharmaceutical manufacturer with a broad portfolio of injectable cardiovascular drugs, including esmolol hydrochloride.

Capabilities and Offerings:

Manufactures esmolol hydrochloride in double-strength formulations designed for hospital use.
Provides products in pre-filled plastic infusion bags and containers for IV administration.
Meets Chinese regulatory standards (NMPA) and seeks approvals in international markets, including the US and Europe.

Market Position: Hengrui’s competitive pricing and extensive manufacturing capacity make it a significant supplier, especially in Asian markets.

3. Novartis

Overview: Novartis, a global pharma leader, markets various cardiovascular agents, including specialized formulations of esmolol.

Capabilities and Offerings:

Offers high-quality esmolol hydrochloride solutions in plastic containers for IV infusion, with proven stability and safety profiles.
Focuses on innovative delivery systems, including double-strength options suitable for intensive care settings.

Market Position: Known for rigorous regulatory compliance and extensive distribution networks, Novartis supplies to hospitals worldwide.

4. Pfizer Inc.

Overview: Pfizer, with a long-standing presence in cardiovascular therapeutics, supplies esmolol hydrochloride under various marketed formulations.

Capabilities and Offerings:

Provides combination products and concentrated formulations, including double-strength solutions in plastic containers.
Emphasizes quality assurance, adherence to cGMP, and global regulatory compliance.

Market Position: Pfizer’s extensive distribution and manufacturing footprint make it an accessible source for healthcare providers globally.

5. Local and Regional Manufacturers

Multiple regional pharmaceutical manufacturers produce esmolol hydrochloride in double strength formulations, primarily catering to local markets in Europe, Asia, and Latin America. Notable mentions include:

Hospira (now part of Pfizer): Historically supplied injectable cardiovascular drugs, including esmolol.
Chengdu Kanghong Pharmaceutical Group: A Chinese producer offering affordable, high-quality intravenous formulations.
Clinigen Group: Supply chain for specialized injectable products, including esmolol.

Procurement and Supplier Selection Considerations

When sourcing esmolol hydrochloride double strength in plastic containers, buyers should prioritize:

Regulatory Compliance: Ensure suppliers hold necessary certifications (e.g., cGMP, ISO 13485, FDA approval) for pharmaceutical manufacturing.
Product Quality and Purity: Verify batch-to-batch consistency, stability data, and quality control standards.
Supply Chain Reliability: Assess supplier capacity, shipping logistics, and availability to meet consistent demand.
Pricing and Contract Terms: Consider volume discounts, lead times, and contractual flexibility.
Documentation & Support: Confirm the availability of comprehensive documentation, including Certificates of Analysis (COA), stability data, and technical support.

Emerging Trends and Innovation in Supply

Innovation in this segment emphasizes:

Pre-filled Systems: Increasing adoption of ready-to-use IV bags with double-strength esmolol to reduce preparation time.
Enhanced Stability: Formulations designed to extend shelf-life and reduce container-breaking risks.
Regional Manufacturing Expansion: To meet local demand for affordable, high-quality IV cardiovascular medicines.

Conclusion

The supply of esmolol hydrochloride double strength in plastic containers is well-established with several global and regional players. While major multinational pharmaceutical companies like Novartis and Pfizer maintain dominant positions through their extensive quality assurance systems, regional manufacturers offer cost-effective alternatives tailored to local needs. Strategic procurement involves assessing regulatory compliance, product quality, supply reliability, and support services. As demand continues to evolve, suppliers investing in formulation innovations and manufacturing capacity are poised to enhance their market share.

Key Takeaways

Global leaders such as Novartis and Pfizer offer high-quality, double-strength esmolol hydrochloride solutions in plastic containers, primarily targeting hospital and ICU settings.
Regional manufacturers in China, India, and Europe provide cost-effective options, often with flexible supply arrangements.
Buyers should prioritize regulatory compliance, product stability, and supply chain reliability when sourcing.
The market is shifting towards pre-filled infusion systems enhancing safety, ease of use, and stability.
Continuous supplier evaluation and quality assurance are essential in maintaining consistent access to this critical cardiovascular medication.

FAQs

1. What are the primary factors influencing the choice of supplier for esmolol hydrochloride double strength in plastic containers?
Regulatory compliance, product quality, supply chain reliability, price competitiveness, and technical support are key factors affecting supplier selection.

2. Are regional manufacturers safe options for procurement of esmolol hydrochloride?
Yes. Many regional manufacturers adhere to local regulatory standards, and some meet international cGMP and ISO certifications, making them reliable sources when properly validated.

3. How does the double-strength formulation benefit hospital use over standard strengths?
Double-strength formulations reduce infusion volume, minimize dosing errors, and facilitate easier administration, especially critical in acute care environments.

4. What challenges exist in sourcing esmolol hydrochloride in plastic containers?
Potential challenges include ensuring product stability, verifying regulatory approvals, managing supply consistency, and maintaining quality assurance across batches.

5. What is the future outlook for the supply chain of esmolol hydrochloride?
Manufacturers are focusing on formulation innovations, regional manufacturing capacity expansion, and supply chain digitization to meet increasing demand reliably and cost-effectively.

References

[1] Bachem AG. Product Portfolio. https://www.bachem.com
[2] Jiangsu Hengrui Medicine Co., Ltd. Corporate Overview. http://www.hengrui.com
[3] Novartis. Cardiovascular Portfolio. https://www.novartis.com
[4] Pfizer Inc. Product Offerings. https://www.pfizer.com
[5] Market Research Reports on IV Cardiovascular Drugs.
[6] Regulatory guidelines on injectable pharmaceutical products.

Note: For procurement, always verify current product availability, regulatory status, and batch-specific documentation directly with suppliers.

Suppliers and packagers for ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER