ISOLYTE S PH 7.4 IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and wholesalers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
B Braun	ISOLYTE S PH 7.4 IN PLASTIC CONTAINER	magnesium chloride; potassium chloride; potassium phosphate, monobasic; sodium acetate; sodium chloride; sodium gluconate; sodium phosphate, dibasic, heptahydrate	INJECTABLE;INJECTION	019696	NDA	B. Braun Medical Inc.	0264-7707-00	12 CONTAINER in 1 CASE (0264-7707-00) / 1000 mL in 1 CONTAINER	1989-09-29
B Braun	ISOLYTE S PH 7.4 IN PLASTIC CONTAINER	magnesium chloride; potassium chloride; potassium phosphate, monobasic; sodium acetate; sodium chloride; sodium gluconate; sodium phosphate, dibasic, heptahydrate	INJECTABLE;INJECTION	019696	NDA	B. Braun Medical Inc.	0264-7707-10	24 CONTAINER in 1 CASE (0264-7707-10) / 500 mL in 1 CONTAINER	1989-09-29
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 19, 2025

Introduction

ISOLYTE S PH 7.4 is a sterile, balanced electrolyte solution designed for intravenous administration in clinical settings. It features a pH level of approximately 7.4, compatible with human blood, enhancing safety for patients requiring hydration, electrolyte replenishment, or medication delivery. Approved and widely used globally, ISOLYTE S in plastic containers is supplied by numerous pharmaceutical manufacturers, contract manufacturing organizations (CMOs), and authorized distributors. This analysis delineates leading suppliers, examining their manufacturing capabilities, regulatory stature, market reach, and strategic considerations to inform procurement decisions.

Key Attributes of ISOLYTE S PH 7.4 in Plastic Containers

Composition: Typically contains sodium chloride, potassium chloride, sodium bicarbonate, and other electrolytes optimized for fluid and electrolyte balance.
Container Type: Pre-filled sterile plastic bags or bottles—often polyethylene or polypropylene—to provide durability, sterility, and ease of administration.
Uses: Hydration therapy, electrolyte correction, adjuvant in drug delivery protocols, particularly for critically ill and surgical patients.

Leading Suppliers of ISOLYTE S PH 7.4 in Plastic Containers

1. Baxter International Inc.

Overview:
Baxter is a global leader in the production of infusion fluids, including ISOLYTE S, with a longstanding reputation for quality and regulatory compliance. Its “Baxter” branded electrolyte solutions, including ISOLYTE S, are available in pre-filled plastic containers, meeting stringent standards across healthcare markets.

Manufacturing Capabilities:
Baxter operates multiple manufacturing facilities compliant with Good Manufacturing Practices (GMP), including US-FDA and EMA certifications, ensuring high-quality production scales. Its technology allows for sterile filling, container integrity, and product stability.

Market Reach:
Baxter supplies ISOLYTE S across North America, Europe, and Asia-Pacific, often through direct distribution channels and authorized medical suppliers. The company partners with hospitals, clinics, and pharmaceutical distributors.

Regulatory Status:
Baxter products are extensively approved by agencies such as the FDA, Health Canada, and the European Medicines Agency, providing assurance of safety and efficacy.

Supply Chain & Availability:
Baxter maintains significant inventory reserves and flexible supply chains, enabling rapid deployment and large-volume procurement.

2. B. Braun Melsungen AG

Overview:
B. Braun specializes in infusion therapy and clinical nutrition, offering electrolyte solutions in various container formats, including ISOLYTE S equivalents or similar balanced electrolyte solutions.

Manufacturing Capabilities:
Its manufacturing facilities in Germany and the U.S. adhere to GMP standards. B. Braun emphasizes innovation in container design—such as plastic bags resistant to leaks and contamination—facilitating sterile, reliable delivery.

Market Reach:
B. Braun’s distribution channels span Europe, the Americas, Asia, and Africa, with tailored product offerings based on regional regulatory approvals.

Regulatory and Quality Assurance:
Certified under various global authorities, B. Braun provides robust documentation and validation processes for its electrolyte solutions.

3. Braun’s Contract Manufacturing & OEM Partnerships

Overview:
In addition to its proprietary products, B. Braun partners with OEMs and contract manufacturers to produce electrolyte solutions like ISOLYTE S for other brand labels or private label customers.

Manufacturing Capabilities:
These partnerships often include custom formulation, container customization, and supply chain management, enabling rapid scalability for large hospital networks or pharmaceutical companies.

Strategic Advantage:
Clients leverage B. Braun’s extensive GMP-compliant facilities to ensure consistent quality and supply chain security.

4. Contract Manufacturing Organizations (CMOs)

Overview:
Several CMOs operate globally, offering sterile filling, formulation, and supply of electrolyte solutions, including ISOLYTE S in plastic containers. These companies may manufacture under client trademarks or as OEMs for established brands.

Leading CMOs Include:

Recipharm:
A top-tier European contract manufacturer offering aseptic filling, with facilities certified by the FDA and EMA. Recipharm provides custom electrolyte solutions in plastic containers optimized for stability and patient safety.
Fresenius Kabi:
Known for its expertise in infusion solutions, Fresenius Kabi produces electrolyte formulations in sterile containers, serving both branded and private-label markets.
AbbVie (Abbott):
Its manufacturing arm offers high-volume production and extensive distribution networks for infusion solutions, including electrolyte therapies.

Advantages of CMOs:

Flexibility in formulation customization.
Cost-effective scaling options.
Rapid responsiveness to global demand surges.

5. Authorized Distributors and Regional Suppliers

Overview:
In addition to primary manufacturers, numerous authorized regional distributors supply ISOLYTE S products, especially in emerging markets or regions with specialized regulatory requirements.

Considerations:

Verify distributor credentials and regulatory approvals.
Ensure proper traceability and documentation.
Confirm product authenticity to prevent counterfeit risks.

Regulatory and Quality Considerations

When sourcing ISOLYTE S in plastic containers, stakeholders should prioritize suppliers with:

GMP Certification: Ensures product consistency and safety.
Regulatory Approvals: FDA, EMA, and equivalent authorities' approval guarantee compliance.
Traceability: Clear batch tracking, expiration dating, and supply chain transparency.
Sterility Assurance: Validated sterilization processes, typically via aseptic filling or terminal sterilization.

Supply Chain Dynamics and Procurement Strategies

In a tightly regulated and safety-critical market like infusion solutions, supply stability is paramount. Factors influencing supplier selection include:

Manufacturing Capacity: To meet fluctuating demand and pandemic-related spikes.
Geographical Presence: Proximity to end-users reduces lead times and logistical risks.
Price and Contract Flexibility: Negotiation leverage for bulk procurement or long-term contracts.
Regulatory Compliance: Fast-track approvals and documentation support seamless procurement.

To mitigate supply chain disruptions, organizations should establish multiple supplier contracts, prioritize manufacturers with high compliance standards, and monitor global regulatory developments influencing availability.

Conclusion

The primary suppliers of ISOLYTE S PH 7.4 in plastic containers include industry titans like Baxter International Inc. and B. Braun Melsungen AG, complemented by specialized CMOs such as Recipharm and Fresenius Kabi. These entities offer high-quality, GMP-compliant products with extensive global distribution networks. Reliable procurement requires evaluating regulatory status, manufacturing capacity, supply chain stability, and product authenticity.

Key Takeaways

Major suppliers like Baxter and B. Braun dominate the ISOLYTE S market, offering proven quality and regulatory compliance.
CMOs present flexible, scalable options, ideal for private labeling or regional supply.
Regulatory certification and sterility validation are critical considerations in supplier selection.
Supply chain resilience is vital; diversify suppliers and establish long-term partnerships.
Continuous monitoring of global regulatory changes ensures uninterrupted access to high-quality electrolyte solutions.

FAQs

1. Is ISOLYTE S in plastic containers available globally?
Yes, major manufacturers and authorized distributors supply ISOLYTE S in plastic containers across North America, Europe, and Asia-Pacific, subject to regional regulatory approvals.

2. How can I verify the authenticity of ISOLYTE S products?
Authenticate through supplier documentation, batch numbers, and regulatory certificates. Purchase from authorized distributors with traceable supply chains.

3. What are the advantages of using plastic containers for electrolyte solutions?
Plastic containers provide sterile environments, durability during transport, ease of handling, and compatibility with infusion equipment, reducing contamination risk.

4. Are there regional suppliers or local manufacturers for ISOLYTE S?
Regional suppliers and CMOs produce electrolyte solutions locally in compliance with GMP, often under licensed agreements, to meet regional demand and regulatory standards.

5. What factors should influence procurement decisions for ISOLYTE S?
Assess supplier quality certifications, manufacturing capacity, regulatory compliance, supply stability, pricing, and logistical capabilities.

Sources

[1] Baxter International Inc. Product information, official website.
[2] B. Braun Melsungen AG. Infusion solutions portfolio.
[3] Recipharm Official Website. Contract manufacturing services.
[4] Regulatory standards: FDA, EMA certifications for sterile injectable manufacturing.

Suppliers and packagers for ISOLYTE S PH 7.4 IN PLASTIC CONTAINER