PHYSIOSOL IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Otsuka Icu Medcl	PHYSIOSOL IN PLASTIC CONTAINER	magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate	SOLUTION;IRRIGATION	017637	NDA	ICU Medical Inc.	0990-6141-09	12 BOTTLE, PLASTIC in 1 CASE (0990-6141-09) / 1000 mL in 1 BOTTLE, PLASTIC	2018-07-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

Physiosol, a sterile, balanced isotonic saline solution used extensively in medical and pharmaceutical applications, is supplied globally in plastic containers. As a critical component in various clinical settings—ranging from wound irrigation to intravenous therapy—the sourcing of Physiosol demands adherence to stringent quality, safety, and regulatory standards. Identifying reliable suppliers for Physiosol in plastic packaging is pivotal for healthcare providers, pharmaceutical distributors, and manufacturers to ensure uninterrupted, compliant, and high-quality supply chains.

Understanding Physiosol and Its Market Demand

Physiosol (also known as isotonic saline or sodium chloride injections) is primarily used for hydration, wound cleansing, and infusion therapy. The global demand is driven by expanding healthcare infrastructure, increasing prevalence of dehydration-related conditions, and expanding pharmaceutical manufacturing operations across emerging markets.

Supply chains for Physiosol are characterized by a subset of key manufacturers that operate under strict Good Manufacturing Practices (GMP), with many complying with international standards such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and international pharmacopoeias.

Key Supplier Profiles for Physiosol in Plastic Containers

1. Baxter International Inc.

Overview: Baxter is a global leader in producing sterile infusion solutions, including Physiosol, in various sterile formats. The company offers Physiosol in pre-filled, sterile plastic bottles, ensuring safety and convenience.

Supply Capabilities: Baxter’s manufacturing facilities in the United States, Ireland, and China possess advanced aseptic processing lines, ensuring high purity and consistent quality. Their extensive distribution network allows for reliable worldwide supply.

Regulatory Compliance: Baxter’s products are approved by major health authorities, including the FDA and EMA, meeting rigorous GMP and ISO standards.

Market Presence: A dominant supplier especially in North America, Europe, and Asia-Pacific, Baxter provides Physiosol solutions suitable for hospitals, clinics, and pharmaceutical OEMs.

2. B. Braun Melsungen AG

Overview: B. Braun is a German-based healthcare company specializing in infusion therapy, including saline solutions in plastic containers. Their Physiosol offerings are packaged in polypropylene bottles with tamper-evident caps.

Supply Capabilities: B. Braun’s manufacturing units in Germany, the United States, and India serve global markets. The company boasts high production volumes, consistent product quality, and a comprehensive distribution network.

Regulatory and Quality Assurance: B. Braun adheres to GMP standards and participates in continuous quality improvement, ensuring the safety and efficacy of their solutions.

Market Presence: Well-established in Europe and North America, with growing penetration in Asian markets.

3. Hospira, A Pfizer Company

Overview: Hospira (now part of Pfizer) specializes in infusion and injectable generic pharmaceuticals, offering Physiosol in various plastic container formats.

Supply Capabilities: Production facilities in the United States, Ireland, and Asia contribute to their extensive supply chain, allowing for large-scale manufacturing aligned with global regulatory demands.

Regulatory Compliance: Products meet FDA, EMA, and other regulatory standards, supported by comprehensive testing and validation protocols.

Market Presence: Widely distributed across healthcare institutions, with growing emphasis on stable supply chains for saline solutions.

4. Braun Medical Inc.

Overview: A subsidiary of B. Braun, Braun Medical Inc. supplies saline solutions in plastic containers primarily for North American markets, emphasizing sterile and pyrogen-free products.

Supply Capabilities: Established manufacturing facilities with established logistics channels ensure product availability across North America.

Regulatory Footprint: GMP compliant, with approvals from the FDA and other relevant authorities.

Emerging and Regional Suppliers

While the above companies are market leaders, several regional players and emerging manufacturers also supply Physiosol in plastic containers:

Guangzhou Wondfo Biotech Co., Ltd. (China): Offers saline solutions suitable for domestic markets, with expanding international distribution.
Ningbo Xianju Sanitary Material Co., Ltd. (China): Provides saline in various packaging formats for local and regional distributors.
Reagecon (United Kingdom): Supplies laboratory-grade sodium chloride solutions, primarily for research and diagnostic use, with some sterile saline products.

Regulatory and Quality Considerations

Choosing reliable suppliers hinges on rigorous assessment of process validation, compliance with pharmacopeia standards (USP, EP, BP), and certifications such as ISO 13485. Manufacturers should provide comprehensive documentation covering manufacturing processes, sterility assurance, stability data, and traceability.

Furthermore, the plastic materials used—typically polypropylene or PET—must meet biocompatibility standards, ensuring no leachables or extractables compromise product safety.

Supply Chain and Logistics Factors

Manufacturing Capacity: Suppliers with scalable production capabilities accommodate fluctuating demand.
Distribution Network: Global reach and local warehousing impact lead times and availability.
Regulatory Approvals: Suppliers with an established history of compliance reduce approval cycles for custom formulations or hospital procurement.
Cost and Contract Terms: Competitive pricing, flexible contractual options, and volume discounts are essential for large-scale procurement.

Key Challenges in Sourcing Physiosol

Regulatory Variability: Different jurisdictions impose distinct registration and approval procedures, influencing supplier selection.
Quality Assurance: Ensuring consistent product quality amidst diverse manufacturing standards.
Supply Chain Disruptions: Global events and logistical challenges can impact order fulfillment.
Environmental Considerations: The move towards sustainable packaging influences supplier offerings.

Conclusion

Secure sourcing of Physiosol in plastic containers necessitates partnerships with reputable, compliant manufacturers that offer reliable quality, scalable capacity, and robust distribution channels. Baxter International, B. Braun Melsungen, and Hospira (Pfizer) stand out as leaders, providing extensive global footprints and regulatory assurance. Regional suppliers can supplement supply in specific markets but must be vetted for standards and consistency. Strategic procurement should prioritize regulatory compliance, product safety, supply chain resilience, and environmental sustainability to ensure uninterrupted, high-quality patient care.

Key Takeaways

Major global suppliers of Physiosol in plastic containers include Baxter International, B. Braun Melsungen, and Hospira (Pfizer), all with extensive GMP compliant manufacturing facilities.
Regulatory adherence and quality assurance are vital when selecting suppliers, particularly regarding sterility, biocompatibility, and compliance certifications.
Supply chain resilience relies on engaging suppliers with scalable capacity and robust distribution networks, especially in response to global logistical challenges.
Regional manufacturers can supplement supply; however, due diligence is essential to verify compliance with international standards.
Environmental sustainability considerations are increasingly influencing packaging choices, prompting demand for eco-friendly plastics and recyclable materials.

FAQs

1. What are the primary qualifications to consider when selecting a Physiosol supplier?
Suppliers should demonstrate GMP compliance, ISO certifications, rigorous quality control processes, and products meeting pharmacopeia standards (USP, EP). Additionally, manufacturing capacity, supply chain reliability, and traceability are critical.

2. Are there any risks associated with sourcing Physiosol from regional or emerging suppliers?
Yes. Risks include variable quality standards, uncertain regulatory compliance, and logistical reliability. It is essential to conduct thorough due diligence, including audits and review of regulatory documentation, before engagement.

3. How do regulatory authorities influence supplier selection?
Authorities like the FDA and EMA enforce strict manufacturing standards. Suppliers with approved and documented compliance streamline approval processes and minimize regulatory hurdles for end-users.

4. What plastic materials are typically used for Physiosol containers, and are they safe?
Polypropylene and PET are common due to their biocompatibility, chemical resistance, and recyclability. Compliance with biocompatibility standards ensures safety and minimizes leachables.

5. How does environmental sustainability impact the procurement of Physiosol containers?
Increasingly, healthcare providers prefer suppliers offering recyclable plastics or reduced plastic usage, aligning with environmental regulations and corporate sustainability goals.

Sources:

Baxter International Inc. Corporate Website. https://www.baxter.com
B. Braun Melsungen AG. Corporate Overview. https://www.bbraun.com
Pfizer Inc. - Hospira segment overview. https://www.pfizer.com
European Pharmacopoeia (EP). Standards for sterile saline solutions.
U.S. Food and Drug Administration (FDA) - GMP guidelines for sterile injections.

Suppliers and packagers for PHYSIOSOL IN PLASTIC CONTAINER