OSMITROL 20% IN WATER: 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	OSMITROL 20% 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 20% 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 20% 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: July 28, 2025

Introduction

Osmitrol (generic name: mannitol) is a crystallizable sugar alcohol used as an osmotic diuretic to reduce intracranial pressure, manage cerebral edema, and treat acute kidney failure. The 20% in water formulation is a standard concentration for intravenous administration, often used in hospital settings worldwide. For pharmaceutical companies, healthcare providers, and distributors, identifying reliable suppliers of Osmitrol 20% in Water is crucial for ensuring drug quality, supply chain stability, and regulatory compliance. This article provides an overview of leading suppliers, their capacities, regulatory standings, and strategic considerations.

Overview of Osmitrol (Mannitol) and Its Pharmaceutical Formulation

Mannitol, produced through the hydrogenation of mannose or the fermentation of yeast extracts, is available in various grades, with pharmaceutical-grade suitable for intravenous use. The 20% solution in sterile water is widely utilized for its osmotic effects. The manufacturing process demands strict adherence to Good Manufacturing Practices (GMP), ensuring sterility, stability, and compatibility with infusion protocols.

In the pharmaceutical industry, the key quality parameters include potency, purity, sterility, pH, osmolality, and endotoxin levels. Suppliers must demonstrate compliance with international standards such as USP, EP, or JP pharmacopoeias, and have robust quality control systems.

Leading Suppliers of Osmitrol 20% in Water

1. Baxter International Inc.

Overview: Baxter is a global leader in intravenous medications, including mannitol formulations. Its Osmitrol product is widely available across North America, Europe, and Asia.

Manufacturing Capabilities: Baxter’s sterile manufacturing facilities adhere to stringent GMP standards, producing high-quality, pyrogen-free solutions. The company invests heavily in quality assurance, ensuring consistent supply and regulatory compliance.

Regulatory Status: Baxter’s Osmitrol has approvals from FDA, EMA, and other regulatory agencies, facilitating international distribution.

Distribution Network: Extensive logistics capabilities ensure timely supply in hospital settings, with dedicated channels for bulk distributors and hospitals.

Strategic Insight: Baxter’s entrenched market presence and rigorous quality controls make it a top choice for bulk procurement.

2. Fresenius Kabi

Overview: Fresenius Kabi specializes in infusion solutions, including mannitol formulations, and has a significant footprint in Europe and emerging markets.

Manufacturing Capabilities: The company operates WHO-GMP certified manufacturing sites, emphasizing sterility, stability, and bioequivalence.

Regulatory Approvals: Its products are approved across multiple jurisdictions, with a strong emphasis on quality compliance and post-market surveillance.

Supply Chain: Known for reliable supply chain management, especially in Europe, Asia, and Latin America.

Strategic Insight: Their focus on affordable, high-quality infusion solutions makes them a key supplier in the global market, especially in developing regions.

3. B. Braun Melsungen AG

Overview: B. Braun manufactures a broad spectrum of infusion therapy products, including mannitol solutions.

Manufacturing Capabilities: The firm’s facilities are GMP-certified, with certifications aligned with FDA and EMA standards, ensuring the sterility and safety of their solutions.

Regulatory Status: B. Braun’s Osmitrol products are extensively registered across the EU, North America, and Asia.

Distribution Network: Strong distribution channels, especially in Europe and Asia, supporting hospitals and pharmaceutical wholesalers.

Strategic Insight: Their existing infrastructure and reputation for high standards make B. Braun a dependable supplier.

4. Pfizer Inc.

Overview: While primarily known for broad-spectrum pharmaceuticals, Pfizer supplies certain sterile infusion solutions, including mannitol in some markets.

Manufacturing Capabilities: Pfizer’s manufacturing quality aligns with global standards, with a focus on innovation, quality, and regulatory compliance.

Regulatory and Distribution: Pfizer’s extensive regulatory approvals and distribution infrastructure make their offerings accessible in multiple regions.

Strategic Insight: Their global presence and established reputation are advantageous for large procurement contracts.

5. Local and Regional Suppliers

In addition to multinational corporations, numerous regional manufacturers supply Osmitrol 20% in water, especially in Asia, Eastern Europe, and Latin America. Examples include:

Shandong Shengquan Biological Technology Co., Ltd (China)
Biopharm Indonesia (Indonesia)
Vensa Health Philippines

These regional suppliers often provide competitive pricing and faster delivery times but require thorough vetting for compliance and quality standards.

Key Considerations for Suppliers Selection

Regulatory Compliance

Choose suppliers with GMP certification and approvals from recognized agencies such as the FDA, EMA, or local authorities. Verify documentation, batch records, and previous inspection reports.

Quality Assurance

Ensure suppliers perform rigorous quality control, including sterility testing, endotoxin testing, and stability assessments.

Capacity and Delivery Reliability

Assess historical delivery performance, production capacity, and contingency planning in case of shortages.

Pricing and Contractual Terms

Negotiate favorable terms, including pricing, payment terms, and exclusivity rights if necessary.

Supply Chain Transparency

Prefer suppliers with transparent supply chains and traceability, crucial for regulatory audits and compliance documentation.

Emerging Trends and Strategic Outlook

Global Supply Chain Resilience

The COVID-19 pandemic underscored the importance of diversifying supply sources to mitigate risks. Companies should consider establishing relationships with multiple suppliers across geographies.

Regulatory Harmonization

Understanding and navigating regulatory requirements across jurisdictions improves procurement agility and reduces compliance risks.

Quality Enhancement Technologies

Investments in advanced manufacturing technologies, such as continuous sterilization and real-time quality monitoring, improve product quality and supply stability.

Sustainable and Ethical Sourcing

Supply chains increasingly demand adherence to environmental and ethical standards, influencing supplier selection and contract clauses.

Conclusion

Securing a reliable source of Osmitrol 20% in Water involves evaluating multiple factors including regulatory compliance, manufacturing quality, supply reliability, and cost. Major multinational corporations such as Baxter, Fresenius Kabi, and B. Braun dominate the global market, offering high-quality, GMP-approved products with extensive distribution networks. Regional suppliers can complement sourcing strategies, especially for localized needs or cost constraints.

Strategic procurement requires due diligence, ongoing supplier assessments, and risk management frameworks to ensure uninterrupted access to this critical pharmaceutical.

Key Takeaways

Prioritize GMP-certified, regulatory-approved suppliers to ensure product safety and compliance.
Diversify sources across geographies to mitigate supply chain disruptions.
Conduct thorough quality audits and review batch history when establishing supplier relationships.
Evaluate supplier capacity and reliability to meet hospital and distribution demands.
Monitor emerging market trends such as regulatory harmonization and supply chain resilience to optimize procurement strategies.

FAQs

1. What are the primary regulatory considerations when sourcing Osmitrol 20% in Water?

Ensure the supplier’s product is approved by recognized agencies such as the FDA or EMA, and that the manufacturing facilities comply with GMP standards. Verify batch documentation, sterility testing, endotoxin levels, and stability data.

2. Which multinational companies are the leading suppliers of Osmitrol 20% in Water?

Baxter International, Fresenius Kabi, and B. Braun Melsungen AG are among the most prominent global suppliers with extensive distribution network and regulatory approval.

3. Can regional suppliers adequately meet global standards for Osmitrol?

Many regional manufacturers hold GMP certifications and can meet local regulatory requirements. However, due diligence regarding quality assurance, regulatory compliance, and manufacturing capacity is necessary before procurement.

4. How has the COVID-19 pandemic affected the supply of Osmitrol?

Supply chains experienced disruptions due to manufacturing slowdowns and logistical challenges. Diversification of suppliers and establishing safety stock have become critical strategies.

5. What should buyers consider beyond price when selecting a supplier for Osmitrol?

Focus on product quality, regulatory compliance, manufacturing capacity, delivery reliability, traceability, and support services to ensure a secure and compliant supply.

References

[1] US Pharmacopeia (USP). Mannitol monohydrate monograph.
[2] European Pharmacopoeia (EP). Mannitol specifications.
[3] Baxter International. Product information for Osmitrol.
[4] Fresenius Kabi. Product portfolio details.
[5] B. Braun Melsungen AG. Infusion therapy product documentation.

Suppliers and packagers for OSMITROL 20% IN WATER