OSMITROL 5% IN WATER 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
Baxter Hlthcare	OSMITROL 5% IN WATER IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	013684	NDA	Baxter Healthcare Company	0338-0353-03	500 mL in 1 BAG (0338-0353-03)	1964-06-08
Baxter Hlthcare	OSMITROL 5% IN WATER IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	013684	NDA	Baxter Healthcare Company	0338-0357-02	250 mL in 1 BAG (0338-0357-02)	1964-06-08
Baxter Hlthcare	OSMITROL 5% IN WATER IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	013684	NDA	Baxter Healthcare Company	0338-0357-03	500 mL in 1 BAG (0338-0357-03)	1964-06-08
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 6, 2025

Introduction

The pharmaceutical market for osmotic agents like Osmitrol (generic: mannitol) plays a crucial role in critical care, neurology, and nephrology. Osmitrol 5% in water in plastic containers is a sterile, hyperosmotic solution used primarily to reduce intracranial pressure, treat cerebral edema, and manage acute kidney injury. Ensuring reliable supply chain partnerships for this medication is vital for healthcare providers and pharmaceutical distributors. This article details the key suppliers capable of manufacturing and distributing Osmitrol 5% in water, emphasizing regulatory standards, production capabilities, and market positioning.

Overview of Osmitrol (Mannitol) 5%

Osmitrol, the branded name for mannitol, is a crystalline sugar alcohol used in medical settings. The 5% aqueous solution is a sterile, isotonic preparation delivered in plastic containers tailored for intravenous use. Its stability, sterility, and compliance with pharmaceutical standards make it essential for hospital pharmacies and regional distributors.

Manufacturers produce both branded and generic versions, adhering to strict regulatory frameworks such as the US FDA, EMA, and other authorities. The supply chain involves raw material suppliers, contract manufacturing organizations (CMOs), and packaging firms specializing in sterile pharmaceuticals.

Leading Suppliers for Osmitrol 5% in Water

1. Baxter International Inc.

Overview:
Baxter is a global leader in sterile injectable drugs and infusion solutions. Their portfolio includes osmotic agents like mannitol, supplied under the Baxter and Baxter Healthcare brands. Baxter’s manufacturing facilities meet or exceed cGMP standards, and their supply chain is robust globally.

Supply Capabilities:

Provides Osmitrol 5% in sterile plastic containers suitable for intravenous infusion.
Extensive distribution networks ensure availability across North America, Europe, and Asia.
Offers both branded and licensed generic equivalents.

Regulatory Status:

Approved by the FDA, EMA, and other regulatory agencies.
Consistent compliance with international pharmaceutical production standards.

Notes:
Baxter’s longstanding experience in sterile fluids makes it a reliable supplier for hospitals and distributors seeking a consistent source of Osmitrol 5%.

2. Fresenius Kabi AG

Overview:
Fresenius Kabi specializes in infusion therapies and offers a broad portfolio of sterile solutions, including mannitol. Their manufacturing plants in Europe and North America meet stringent quality standards.

Supply Capabilities:

Produces 5% mannitol solutions in various plastic containers, including pre-filled bags and bottles.
Focuses on sterile, pyrogen-free products suitable for critical care.
Has global distribution channels optimized for timely delivery.

Regulatory Status:

Approved across multiple markets with extensive quality certifications.
Follows ISO, cGMP, and other pertinent standards.

Notes:
Fresenius Kabi’s reputation for quality and reliability in infusion products positions them as a preferred supplier, especially for European markets.

3. Hikma Pharmaceuticals PLC

Overview:
Hikma is a leading manufacturer of generic injectables, including osmotic agents like mannitol. Their facilities in the Middle East and North America produce high-quality sterile solutions for global export.

Supply Capabilities:

Manufactures 5% mannitol in sterile plastic containers, complying with international standards.
Offers flexible supply options tailored to hospital procurement needs.
Ensures product stability and sterility for intravenous administration.

Regulatory Status:

Approved by the FDA and other major authorities.
Holds multiple manufacturing and quality certifications.

Notes:
Hikma’s focus on high-volume sterile injectables makes it a significant supplier for large healthcare systems seeking cost-effective sources.

4. Hospira (a Pfizer company)

Overview:
Hospira is historically known for sterile injectable medications, now part of Pfizer. Its portfolio includes osmotic agents like mannitol, supplied in sterile containers.

Supply Capabilities:

Provides consistent, high-quality 5% mannitol in plastic containers suited for IV therapy.
Extensive distribution network across North America, EU, and Asia.

Regulatory Status:

Approved and certified by the FDA, EMA, and other regulatory bodies.
Complies with rigorous quality standards, including cGMP.

Notes:
Although now part of Pfizer, Hospira maintains its manufacturing standards and global supply reliability.

Contract Manufacturing Organizations (CMOs) & Private Label Suppliers

In addition to major pharmaceutical companies, several CMOs specialize in sterile solution manufacturing, offering private label Osmitrol 5%. These organizations often serve as OEM (Original Equipment Manufacturer) partners for established drug brands seeking expanded capacity.

Examples Include:

CMO companies like Patheon (Thermo Fisher Scientific): Offers sterile injectable manufacturing, including mannitol solutions in plastic containers.
Recipharm: Provides contract manufacturing services for sterile pharmaceuticals, including osmotic agents.

Note:
Partnerships with CMOs require considerable due diligence regarding quality standards, regulatory compliance, and supply capacity.

Regulatory and Market Considerations

Reliable supply of Osmitrol 5% depends heavily on compliance with Good Manufacturing Practice (GMP), rigorous quality control, and the capacity to meet regional regulatory requirements. The market is saturated with both branded and generic providers, but demand for high-quality, regulated products remains a key differentiator.

Importantly, geopolitical and supply chain disruptions can affect availability. Strategic partnerships with established, GMP-compliant manufacturers mitigate risks associated with shortages.

Emerging Suppliers & Innovation

Advances in biopharmaceutical manufacturing and sterile solution stabilization may expand supplier options in the coming years. Companies investing in innovative container designs, longer shelf life, and reduced endotoxin levels are poised to improve supply resilience.

Additionally, regional manufacturers in Asia, Europe, and North America are expanding their production capacity to meet growing global demand, especially amid ongoing global health emergencies.

Key Takeaways

Major global pharmaceutical companies such as Baxter, Fresenius Kabi, Hikma, and Pfizer/Hospira represent the primary suppliers of Osmitrol 5% in water in plastic containers.
These suppliers maintain comprehensive regulatory compliance, ensuring product safety and efficacy.
Contract manufacturing organizations provide customizable manufacturing solutions but require rigorous vetting.
Supply chain resilience depends on strategic partnerships with GMP-compliant manufacturers, especially in the face of geopolitical and logistical challenges.
Ongoing innovations in container technology and manufacturing processes may diversify future supply sources.

Frequently Asked Questions (FAQs)

What are the primary considerations when selecting a supplier for Osmitrol 5%?
Regulatory compliance, manufacturing standards (GMP), supply reliability, product quality, and regional distribution capabilities.
Are there generic alternatives to Osmitrol branded products?
Yes, several pharmaceutical manufacturers produce generic mannitol solutions in similar sterile containers, subject to regional regulatory approval.
How do supply chain disruptions impact Osmitrol availability?
Disruptions due to geopolitical issues, raw material shortages, or manufacturing delays can lead to shortages, emphasizing the importance of diversified supplier networks.
Can hospitals source Osmitrol from regional manufacturers or only global brands?
Regional manufacturers often supply locally approved sterile solutions, but clinicians should verify regulatory approval and product quality.
What regulations govern the manufacturing of Osmitrol solutions?
The manufacturing must adhere to cGMP standards outlined by agencies like the FDA, EMA, and equivalent regulatory bodies worldwide.

Conclusion

Securing dependable suppliers for Osmitrol 5% in water, packaged in plastic containers, remains critical for healthcare providers managing neurocritical and nephrological conditions. Established global manufacturers like Baxter, Fresenius Kabi, Hikma, and Hospira stand out due to their extensive manufacturing capabilities and regulatory certifications. Strategic sourcing, coupled with rigorous quality oversight, ensures the uninterrupted availability of this essential osmotic agent, ultimately supporting optimal patient outcomes amid a complex and dynamic pharmaceutical landscape.

References

[1] Baxter International Inc. Official Website, accessed 2023.
[2] Fresenius Kabi. Product Portfolio, accessed 2023.
[3] Hikma Pharmaceuticals PLC. Corporate Overview, accessed 2023.
[4] Pfizer Inc. (Hospira). Sterile Injectable Solutions, accessed 2023.
[5] U.S. Food and Drug Administration (FDA). Guidelines for Sterile Injectable Manufacturing, 2022.

Suppliers and packagers for OSMITROL 5% IN WATER IN PLASTIC CONTAINER