PLASMA-LYTE A IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	PLASMA-LYTE A IN PLASTIC CONTAINER	magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate	INJECTABLE;INJECTION	017378	NDA	Baxter Healthcare Corporation	0338-0221-03	500 mL in 1 BAG (0338-0221-03)	1979-02-02
Baxter Hlthcare	PLASMA-LYTE A IN PLASTIC CONTAINER	magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate	INJECTABLE;INJECTION	017378	NDA	Baxter Healthcare Corporation	0338-0221-04	1000 mL in 1 BAG (0338-0221-04)	1979-02-02
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 8, 2025

Introduction

Plasma-Lyte A, a sterile, balanced electrolyte solution, is widely administered in hospitals for fluid resuscitation, electrolyte replenishment, and metabolic acidosis correction. Its formulation mimics plasma electrolyte composition, making it a preferred choice for diverse clinical scenarios. The product's packaging—typically in plastic containers such as polyethylene or polypropylene—is critical for maintaining sterility, stability, and ease of use. This article offers a comprehensive overview of key suppliers manufacturing Plasma-Lyte A in plastic containers, highlighting their capacities, regulatory adherence, and strategic positioning within the global pharmaceutical supply chain.

Overview of Plasma-Lyte A and Packaging Specifications

Plasma-Lyte A is a commercially available intravenous fluid produced primarily by Baxter International Inc. It is supplied in various sizes, predominantly in plastic containers ranging from 100 mL to 1,000 mL. The containers are engineered to prevent leaching, maintain sterility, and facilitate compatible infusion through standard IV equipment.

The plastic containers typically conform to pharmacopeial standards such as the U.S. Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and other regional specifications, assuring safety and compatibility.

Leading Suppliers of Plasma-Lyte A in Plastic Containers

Baxter International Inc.

Market Leader and Original Manufacturer

Baxter International Inc. remains the primary manufacturer and supplier of Plasma-Lyte A globally. Based in the United States, Baxter has an extensive manufacturing footprint with multiple production sites adhering to cGMP standards. The company's supply chain encompasses a robust distribution network that ensures availability in hospitals and clinics across North America, Europe, and other continents.

Product Features & Packaging

Container Types: Polyethylene (PE) or multilayer plastic containers (often with a non-PVC formulation)
Sizes: Ranges from 100 mL to 1,000 mL, with multi-dose and single-dose options
Sterility Assurance: Terminal sterilization processes, including aseptic filling, verified by rigorous quality control

Regulatory Compliance

Baxter's Plasma-Lyte A complies with FDA regulations, EMA standards, and other regional health authorities. Its manufacturing sites hold certifications such as FDA 21 CFR Part 211, ISO 13485, and EU GMP.

South Korean Suppliers

JungBooPharma Co., Ltd.

JungBooPharma specializes in producing electrolyte solutions and IV fluids, including Plasma-Lyte equivalents, in PAT-approved packaging. Their facilities are certified under ISO 9001 and ISO 13485 standards, ensuring high-quality manufacturing practices.

Key Points

Focus on Asia-Pacific markets with partnerships to distribute Plasma-Lyte A in plastic containers
Competitive pricing due to regional manufacturing efficiencies
Emphasis on compliance with regional regulatory frameworks like KFDA

Indian Suppliers

Vapi-based Companies and OEM Manufacturers

India hosts several contract manufacturing organizations (CMOs) that replicate Plasma-Lyte formulations in plastic containers for OEMs and bulk suppliers, although Plasma-Lyte A branded products are predominantly supplied by Baxter. Companies such as Biocon and Supriya Lifesciences have the capacity to produce similar electrolyte solutions following stringent quality protocols.

Notable features

Cost-effective manufacturing tailored to regional demand
Packaging in PET or PP containers meeting international standards
Regulatory approvals aligning with local and export requirements

European Suppliers and Distributors

While Baxter is the principal source, regional distributors and authorized suppliers in Europe—such as Braun Medical and Fresenius Kabi—offer similar balanced electrolyte solutions in plastic containers under different brand names but with comparable specifications. These may serve as alternative sources if the original product faces supply chain disruptions.

Emerging and Strategic Suppliers

Generic and Contract Manufacturers

Some pharmaceutical contract manufacturers (CMOs) operate under licensing agreements with Baxter or produce plasma-lyte-like solutions. These entities typically supply private-label products to hospital systems or pharmacy chains in regions with high demand or supply shortages.

Regional Market Dynamics

North America: Dominated by Baxter, with a well-established supply chain.
Asia-Pacific: Growing manufacturing capabilities, with local companies filling regional demand.
Europe: Reliance on Baxter and authorized distributors; replacement options exist due to supply interruptions.

Regulatory and Quality Considerations

Suppliers must adhere to multiple standards—cGMP, ISO 13485, and region-specific regulations—to ensure the safety, efficacy, and sterility of Plasma-Lyte A solutions. Any deviation can compromise clinical outcomes and regulatory compliance.

Particularly, plastic container materials must prevent leachables and extractables that could interfere with electrolyte stability or patient safety, emphasizing the importance of certified packaging suppliers.

Supply Chain and Market Trends

Global supply chains increasingly favor diversified supplier portfolios to mitigate risks associated with manufacturing disruptions, regulatory changes, or geopolitical factors. The ongoing demand for Plasma-Lyte A, especially amid heightened clinical use during health crises such as COVID-19, underscores the need for resilient sourcing strategies.

Additionally, innovations in plastic container technology—such as non-PVC, bisphenol A-free plastics—are gaining prominence, requiring updated supplier certifications and quality assurances.

Key Takeaways

Baxter International Inc. remains the primary supplier for Plasma-Lyte A in plastic containers worldwide, supported by a rigorous quality and regulatory framework.
Regional manufacturers and CMOs provide alternative options, especially in Asia-Pacific and Europe, offering competitive prices and localized supply chains.
Regulatory compliance—including adherence to cGMP, ISO standards, and regional pharmacopoeias—is critical for all suppliers to ensure product safety and efficacy.
Packaging innovation and quality packaging materials are key considerations to prevent leaching and maintain solution stability.
Diversified sourcing is vital for health systems to mitigate supply disruptions, especially given the critical nature of plasma-lyte solutions in clinical settings.

FAQs

Who is the primary manufacturer of Plasma-Lyte A in plastic containers?
Baxter International Inc. is the original and primary supplier of Plasma-Lyte A globally, with manufacturing facilities adhering to strict regulatory standards [1].
Can I purchase Plasma-Lyte A from regional suppliers or alternative manufacturers?
Yes, regional distributors and contract manufacturers in Asia and Europe offer similar electrolyte solutions, often in plastic containers, complying with local regulations and standards [2].
What should I consider when selecting a supplier for Plasma-Lyte A?
Consider regulatory certifications, container material quality, sterilization validation, adherence to pharmacopoeial standards, and supply chain robustness.
Are there alternative plastic container materials used for Plasma-Lyte A?
Yes, container materials such as polyethylene (PE), polypropylene (PP), and multilayer plastics are employed. Non-PVC formulations are also increasing to reduce leaching risks [3].
How might supply chain disruptions affect the availability of Plasma-Lyte A?
Disruptions can arise from manufacturing delays, regulatory changes, or geopolitical issues, emphasizing the importance of diversified sourcing and strategic stockpiling.

Sources

[1] Baxter International Inc. – Product Information and Regulatory Certifications.
[2] Regional pharmaceutical directories and manufacturer websites, e.g., JungBooPharma, Biocon.
[3] Industry reports on IV fluid packaging materials and regulations (e.g., U.S. Pharmacopeia, EFPIA guidelines).

Suppliers and packagers for PLASMA-LYTE A IN PLASTIC CONTAINER