OSMITROL 5% IN WATER: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	OSMITROL 5% IN WATER	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	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	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 8, 2025

Introduction

OSMITROL 5% in water (mannitol injection), a hyperosmolar solution primarily used to reduce intracranial pressure and cerebral edema, is a critical pharmaceutical product with a global demand. With its vital role in acute care and neurology, the sourcing and supply chain integrity are paramount for healthcare providers ensuring patient safety and medication availability. This article evaluates key suppliers of OSMITROL 5% in water, analyzing manufacturer profiles, distribution channels, and market dynamics.

Manufacturer Overview

Fresenius Kabi:
Fresenius Kabi, headquartered in Germany, stands as one of the leading manufacturers of mannitol injections, including OSMITROL 5%. Known for its rigorous quality assurance and large-scale production capacity, Fresenius supplies this medication across numerous markets globally. Their reputation hinges on compliance with international standards such as GMP (Good Manufacturing Practices) and ISO certifications, making them a primary go-to supplier for hospitals and pharmaceutical distributors [1].

Baxter International:
Baxter supplies sterile injectable drugs, including mannitol, through its extensive global network. Their focus on innovation and quality control ensures a consistent supply of OSMITROL 5%. Baxter’s strategic global manufacturing facilities enable rapid distribution, critical in emergency settings [2].

B.Braun Melsungen AG:
This German medical device and pharmaceutical company produces high-quality mannitol products, including OSMITROL 5%. Known for its robust compliance protocols, B.Braun serves hospitals directly and via authorized distributors, emphasizing safety and efficacy.

Hospira (a Pfizer company):
Although Pfizer's unit Hospira has scaled back certain product lines, it remains a notable player in the sterile injectable market. Their production of mannitol formulations continues to serve specific markets where quality and reliability are critical.

Other Notable Manufacturers:

Fresenius Kabi India and West-Ward (part of Mylan): These regional entities produce generic versions and could serve as alternative sources, especially for bulk supply or in regions with local manufacturing regulations.

Distribution Channels

Authorized Distributors and Wholesalers:
Most pharmaceutical manufacturers, including Fresenius Kabi and Baxter, partner with licensed distributors who handle procurement, storage, and distribution of OSMITROL 5%. These partners play a key role in ensuring supply chain integrity, especially in regions with regulatory restrictions.

Direct Procurement by Healthcare Institutions:
Larger hospitals and healthcare systems may establish direct procurement agreements with manufacturers, particularly in countries with advanced healthcare procurement frameworks like the US and EU.

Online and Regional Suppliers:
In some markets, especially developing regions, authorized online platforms and local suppliers supply OSMITROL 5%, subject to regulatory compliance. However, caution is warranted to mitigate counterfeit risks.

Geographic Market Considerations

United States:
The U.S. Food and Drug Administration (FDA) approves and regulates OSMITROL 5%. Major suppliers include Fresenius Kabi and Baxter, with distribution through licensed wholesalers such as McKesson and Cardinal Health.
European Union:
European supply relies heavily on Fresenius Kabi and B.Braun, with products registered under CE markings and compliance with EU GMP standards.
Asia-Pacific:
Regional suppliers, including Indian companies like Sun Pharma and Lupin, manufacture generic versions, often under licensing agreements with international firms. These may serve regional markets with competitive pricing but may have different quality assurance protocols.
Emerging Markets:
Supply chains are more fragmented, relying on local importers, sometimes with limited regulatory oversight, increasing the importance of supplier validation.

Quality and Regulatory Certifications

Suppliers of OSMITROL 5% must adhere to strict regulatory standards. Essential certifications include:

GMP Compliance: Ensures products are consistently produced to quality standards.
ISO Certification: General quality management (ISO 9001) applicable.
FDA/EMA Approved Facilities: For the U.S. and European markets, respectively.
Pharmacovigilance Records: Demonstrating commitment to safety monitoring.

Sourcing from certified suppliers diminishes risks linked to substandard or counterfeit products, which is critical in injectable medications.

Market Dynamics and Supply Chain Challenges

Raw Material Availability:
Mannitol, derived from corn or plant-based sources, faces supply variability impacted by agricultural factors and energy prices.
Manufacturing Capacity Constraints:
During health crises, such as COVID-19, manufacturing and distribution of critical injectables like OSMITROL 5% faced bottlenecks.
Regulatory Barriers and Import Legislation:
Differing regional standards can hinder the international movement of medicinal products; therefore, verification of compliance is essential.
Price Pressures and Generic Competition:
Generic versions from regional manufacturers can drive price competitiveness but require rigorous quality validation.

Conclusion

Leading Suppliers of OSMITROL 5% in Water:
The most reliable suppliers globally include Fresenius Kabi, Baxter International, and B.Braun Melsungen AG. These entities maintain extensive manufacturing capacity, adhere to strict regulatory standards, and possess well-established distribution networks ensuring consistent availability. Regional and generic suppliers further complement the supply chain, especially in emerging markets, but require careful validation regarding quality assurances.

Healthcare providers and distributors should prioritize sourcing from approved manufacturers with demonstrated GMP compliance and certifications. Maintaining supply chain resilience necessitates diversifying suppliers and establishing strategic partnerships to mitigate risks associated with manufacturing disruptions.

Key Takeaways

Primary Supplier Focus: Fresenius Kabi, Baxter, and B.Braun dominate the global supply of OSMITROL 5%, emphasizing the importance of engaging with these manufacturers for dependable supply.
Regulatory Compliance: Ensuring all suppliers possess necessary GMP, ISO, and market-specific approvals minimizes the risk of counterfeit or substandard products.
Regional Variability: Procurement strategies must consider regional manufacturing and regulatory landscapes to optimize supply chain robustness.
Supply Chain Risks: Factors such as raw material shortages, manufacturing capacity, and legislative barriers impact OSMITROL 5% availability; proactive sourcing and inventory management are crucial.
Future Opportunities: As demand for injectable medications increases, manufacturers investing in capacity expansion and regulatory harmonization will likely strengthen their market positions.

FAQs

1. Who are the leading global manufacturers of OSMITROL 5% in water?
Fresenius Kabi, Baxter International, and B.Braun Melsungen AG are the primary global manufacturers offering high-quality OSMITROL 5%, adhering to international standards and extensive distribution networks.

2. How can healthcare providers ensure the quality of OSMITROL 5% supplies?
By sourcing exclusively from manufacturers with valid GMP and ISO certifications, verifying product approvals from relevant regulatory agencies (FDA, EMA), and conducting periodic audits of suppliers.

3. Are generic or regional manufacturers reliable sources for OSMITROL 5%?
They can be, provided they hold comparable regulatory approvals, certifications, and demonstrate consistent quality. Validation and due diligence are essential before procurement.

4. What are the main supply chain challenges for OSMITROL 5%?
Raw material constraints, manufacturing capacity limitations during crises, regulatory restrictions, and risks of counterfeit products pose ongoing challenges.

5. How might future market trends affect the supply of OSMITROL 5%?
Increasing global healthcare demand, technological innovations, and regulatory harmonization could enhance manufacturing capacity and supply chain resilience, ensuring stable availability.

References

[1] Fresenius Kabi official website, "Our Products," Accessed 2023.
[2] Baxter International, "Product Portfolio," Official Site, 2023.

Suppliers and packagers for OSMITROL 5% IN WATER