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Suppliers and packagers for ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER
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ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hq Spclt Pharma | ESMOLOL HYDROCHLORIDE 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 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 |
Suppliers for the Pharmaceutical Drug: Esmolol Hydrochloride in Plastic Container
Introduction
Esmolol hydrochloride, a short-acting beta-adrenergic blocker, is routinely administered intravenously in critical care and surgical settings to manage arrhythmias, hypertensive emergencies, and perioperative hypertension. Its rapid onset and brief duration of action make it vital in acute management. Pharmaceutical supply chains depend heavily on reliable suppliers offering high-quality Esmolol hydrochloride in plastic containers, ensuring stability, sterility, and efficacy. This article evaluates leading global and regional suppliers in this domain, focusing on their manufacturing capabilities, compliance standards, and market positioning.
Global Manufacturers and Suppliers
1. Pfizer Inc.
Overview: Pfizer, a pioneer in cardiovascular drugs, manufactures Esmolol hydrochloride with a comprehensive portfolio covering multiple formulations. The company's global supply chain is robust, ensuring widespread availability. Pfizer’s manufacturing facilities adhere to cGMP guidelines, with global certifications from EMA, FDA, and other regulatory bodies.
Supply Capabilities: Pfizer supplies Esmolol hydrochloride in sterile, single-use plastic infusion bags, primarily for hospital use. The company ensures high sterility standards, stability, and batch consistency. Their distribution network supports timely delivery globally.
Regulatory Compliance: Strict adherence to GMP and ISO standards underpins Pfizer's manufacturing processes, ensuring quality assurance. Their products are approved across major markets, including the US, EU, and Asia.
2. Fresenius Kabi
Overview: Fresenius Kabi specializes in infusion solutions, clinical nutrition, and biosimilars. The company produces Esmolol hydrochloride as part of its portfolio of injectable therapeutics, supplied predominantly as ready-to-use infusion solutions in plastic containers.
Supply Capabilities: Their manufacturing facilities are certified by the FDA and EMA, emphasizing sterile processing and container integrity. They offer Esmolol hydrochloride in prefilled plastic bags that are designed to maintain stability and prevent contamination.
Market Reach: With extensive distribution channels across North America, Europe, and emerging markets, Fresenius Kabi frequently supplies hospitals and healthcare providers with their proprietary infusion systems.
3. Boehringer Ingelheim
Overview: Boehringer Ingelheim’s cardiology products include injectable beta-blockers, among them Esmolol hydrochloride. Their focus on research and development ensures product reliability and innovation.
Supply Capabilities: The company produces Esmolol hydrochloride in sterile plastic containers, aligning with industry standards for hospitals and clinics. Their manufacturing is compliant with stringent quality management systems, making them a trusted supplier.
Regulatory Standing: Their sterile injectable products benefit from approvals by regulatory agencies worldwide, and they maintain high standards for container integrity and drug stability.
4. Beijing Kia Pharma Ltd. (China)
Overview: A regional manufacturer, Beijing Kia Pharma supplies Esmolol hydrochloride to the Asia-Pacific market. They specialize in injectable drugs and infusion solutions supplied in plastic containers.
Supply Capabilities: They provide competitively priced Esmolol hydrochloride in polyethylene or PVC bags suitable for infusion therapy, with quality standards aligned to Chinese and international regulations.
Market Position: Their focus on local markets allows their products to meet relevant regulatory demands efficiently, serving a broad network of hospitals in China and neighboring countries.
Regional and Emerging Market Suppliers
5. Jiangsu Hengrui Medicine Co., Ltd. (China)
Hengrui medicines manufacture Esmolol hydrochloride for domestic distribution, manufacturing in compliance with Chinese GxP standards. They supply in plastic infusion containers following regulatory approvals and Good Manufacturing Practice (GMP). Their focus is on cost-effective production to meet regional demands.
6. Sun Pharmaceutical Industries Ltd. (India)
Sun Pharma produces a range of injectable drugs, including Esmolol hydrochloride in plastic infusion bottles. Their manufacturing facilities are certified by the Indian Drug Controller General and international agencies, emphasizing quality and supply stability.
7. Akorn, Inc. (USA)
Akorn offers sterile injectable products with a focus on hospital markets. Their Esmolol hydrochloride solutions are available in plastic containers, primarily targeting the North American healthcare sector.
Key Considerations When Selecting Suppliers
- Regulatory Approvals: Ensure suppliers possess necessary approvals (FDA, EMA, TGA, etc.)
- Manufacturing Standards: Confirm adherence to cGMP, ISO certifications.
- Product Stability and Container Material: Plastic containers must meet safety standards to prevent leaching or contamination.
- Supply Chain Reliability: Evaluate past delivery performance and capacity management.
- Pricing and Market Approval: Competitive pricing and local registration can influence procurement choices.
Emerging Trends and Market Outlook
The global market for intravenous beta-blockers like Esmolol hydrochloride continues to grow, driven by increasing surgical procedures and critical care needs. Suppliers investing in scalable, compliant manufacturing facilities and robust distribution networks will maintain competitive advantages. Regional players catering to local markets provide cost-effective solutions, with increasing demand for quality-assured, sterile plastic container formulations.
Key Takeaways
- Leading global suppliers of Esmolol hydrochloride in plastic containers include Pfizer, Fresenius Kabi, and Boehringer Ingelheim, distinguished by high regulatory compliance and robust distribution networks.
- Regional manufacturers such as Beijing Kia Pharma and Jiangsu Hengrui offer cost-effective alternatives primarily serving Asian markets.
- The choice of supplier should prioritize regulatory approvals, manufacturing standards, product stability, and supply chain reliability.
- The pharmaceutical industry’s shift toward ready-to-use infusion solutions in plastic containers aligns with enhanced patient safety and operational efficiency.
- Continuous innovation and capacity expansion will sustain supplier competitiveness amid growing global demand.
FAQs
1. What are the key manufacturing standards for Esmolol hydrochloride in plastic containers?
Manufacturers must comply with cGMP, ISO standards, and regulatory approvals like FDA or EMA, ensuring sterile processing, container integrity, and consistent potency.
2. Which regions have the most reliable suppliers of Esmolol hydrochloride in plastic containers?
North America (Pfizer, Akorn), Europe (Fresenius Kabi, Boehringer Ingelheim), and Asia (Jiangsu Hengrui, Beijing Kia Pharma) are primary regions with established suppliers.
3. Are there any notable differences in container types for Esmolol hydrochloride?
Most suppliers use sterile polyethylene, PVC, or polypropylene infusion bags or bottles, optimized to maintain stability and prevent contamination.
4. How does supplier quality impact patient safety?
High-quality suppliers ensure sterile, contamination-free products with accurate dosing, minimizing adverse events and ensuring therapeutic efficacy.
5. What trends are influencing the future supply of Esmolol hydrochloride?
Automation in manufacturing, stricter regulatory standards, and increased demand for ready-to-use infusion systems will drive supplier innovation and capacity expansion.
References
[1] Pfizer Inc. Corporate Website.
[2] Fresenius Kabi Product Portfolio.
[3] Boehringer Ingelheim Product Information.
[4] Chinese National Drug Approval Records.
[5] Sun Pharmaceutical Official Site.
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