OSMITROL 10% IN WATER: 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 10% 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 10% 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 10% 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 7, 2025

Introduction

OSMITROL 10% IN WATER is a hypertonic solution primarily used to treat cerebral edema and intracranial hypertension. Its active ingredient is mannitol, a monosaccharide alcohol, which functions as an osmotic diuretic. Due to its critical medical applications, the supply chain is tightly regulated, requiring adherence to stringent manufacturing standards such as Good Manufacturing Practices (GMP) and compliance with pharmacopoeial specifications. This article offers a comprehensive overview of global suppliers capable of providing OSMITROL 10% IN WATER, analyzing their manufacturing capabilities, regulatory compliance, and distribution networks.

Manufacturers of Mannitol and OSMITROL

The production of OSMITROL 10% IN WATER depends fundamentally on high-quality mannitol raw material, with specific pharmaceutical-grade standards: USP (United States Pharmacopeia), EP (European Pharmacopoeia), or JP (Japanese Pharmacopoeia). Leading manufacturers of pharmaceutical-grade mannitol form the core of suppliers for drugs like OSMITROL.

Key Suppliers of Pharmaceutical-Grade Mannitol

1. Roquette Frères

Overview: A global leader in specialty ingredients, Roquette manufactures pharmaceutical-grade mannitol under the brand names like "Pearlitol."
Capabilities: Roquette's GMP-certified manufacturing facilities in France and the US produce high-purity mannitol suitable for injectables and infusion solutions.
Regulatory Compliance: Adheres to U.S. FDA, EMA, and other global regulatory standards, ensuring supply chain integrity for pharmaceutical applications.
Distribution Network: Offers extensive availability in North America, Europe, and Asia-Pacific regions.

2. Merck KGaA (EMD Millipore)

Overview: Merck’s division for life science products supplies pharmaceutical-grade excipients and raw materials.
Capabilities: Produces pharmaceutical-grade mannitol with consistent quality standards, suitable for parenteral formulations.
Certifications: GMP compliant; includes ISO 9001 and ISO 13485 accreditations.
Market Presence: Extensive distribution channels spanning Europe, North America, and Asia.

3. MilliporeSigma (a subsidiary of Merck KGaA)

Overview: Specializes in high-quality excipients, including mannitol for parenteral uses.
Capabilities: Offers mannitol under stringent quality standards for injectable solutions.
Quality Assurance: Meets U.S. and European pharmacopoeial standards, ensuring safety and purity.

4. Thermo Fisher Scientific

Overview: Supplies pharmaceutical-grade excipients, including mannitol, with a focus on injectable formulations.
Manufacturing Standards: Operates GMP-certified facilities globally.
Supply Reach: Serves North America, Europe, and the Asia-Pacific market.

5. Fuso Pharmaceutical Industries

Overview: Japanese manufacturer providing pharmaceutical excipients, including mannitol.
Compliance: Meets Japanese Pharmacopoeia standards and global regulatory requirements.
Distribution: Primarily within Asia, with export capabilities to other regions.

Manufacturers of OSMITROL 10% IN WATER Specifically

While OSMITROL is a branded formulation of mannitol developed by specific pharmaceutical companies, generic versions or similar formulations may be produced by reputable pharmaceutical manufacturers globally. The original manufacturer of OSMITROL, now under AbbVie (formerly part of Baxter), produces and supplies the branded product primarily in select regions.

1. AbbVie (formerly Baxter International)

Overview: Original developer of OSMITROL.
Manufacturing: Dedicated facilities produce pharmaceutical-grade mannitol solutions, including 10% in water formulations.
Regulatory Framework: Full compliance with FDA, EMA, and other regional agencies.
Distribution: Predominantly in North America, Europe, and select markets through authorized distributors.

2. Hospital/Institutional Pharmaceutical Suppliers and Distributors

In addition to original manufacturers, several regional pharmaceutical distributors supply OSMITROL 10% IN WATER, often sourcing directly from original producers or approved generics.

United States: Cardinal Health, McKesson, and AmerisourceBergen distribute OSMITROL through hospital systems.
Europe: Agencies such as Phoenix Pharma and Gehe Pharma retailers distribute branded and generic mannitol solutions.
Asia-Pacific: Local distributors often import from manufacturers in Japan, China, or India, offering competitively priced formulations.

Regional and Contract Manufacturing

Contract Manufacturing Organizations (CMOs):
Several CMOs worldwide offer contract manufacturing of mannitol solutions to pharmaceutical companies seeking scalable or proprietary formulations.

Bachem AG: Provides contract development and manufacturing for injectable products, including mannitol formulations.
Recipharm: Offers manufacturing expertise in sterile solutions, including 10% mannitol solutions for IV use.
Vetter Pharma: Specializes in aseptic fill-finish services alongside excipient compounding.

Such partnerships enable pharmaceutical companies to secure consistent, GMP-compliant supply of OSMITROL or similar formulations.

Regulatory Landscape and Quality Assurance

Supply chain integrity hinges on strict adherence to regulatory standards. Manufacturers and suppliers are required to provide Certificates of Analysis (CoA), Certificates of Compliance (CoC), and batch documentation aligning with pharmacopeial standards (USP, EP, JP). Regular audits and compliance checks safeguard against substandard products entering the supply chain.

The complexity of importing, licensing, and distributing OSMITROL in different regions underscores the importance of working with suppliers holding active regulatory approvals. This ensures smooth procurement and minimizes risk of formulation variability or regulatory non-compliance.

Emerging Trends and Supply Chain Considerations

Globalization and Sourcing Variability: The COVID-19 pandemic exposed vulnerabilities in supply chains, prompting diversification of supplier bases.
Quality and Traceability: Increasing emphasis on traceability and quality assurance has led to tighter vendor qualification processes.
Local Manufacturing: Regions are investing in local manufacturing to mitigate supply disruptions, especially for essential medicines.

Healthcare providers and distributors should prioritize suppliers with proven regulatory compliance, robust manufacturing practices, and reliable logistics capabilities.

Key Takeaways

Leading Raw Material Suppliers: Roquette Frères, Merck KGaA, MilliporeSigma, Thermo Fisher Scientific, and Fuso Pharmaceutical are primary sources of pharmaceutical-grade mannitol suitable for OSMITROL production.
Original Manufacturer: AbbVie's OSMITROL continues to be supplied through authorized distributors, primarily in North America and Europe.
Global Supply Chain: Regional distributors and CMOs expand access, ensuring manufacturers and healthcare providers meet patient needs efficiently.
Regulatory Compliance: Suppliers must demonstrate adherence to GMP, USP, EP, or JP standards and provide comprehensive documentation.
Supply Chain Resilience: Diversification, local manufacturing, and strict quality controls are essential to maintain secure supply channels.

5 Unique FAQs

1. Can I procure OSMITROL 10% IN WATER directly from manufacturers?
Yes, but typically through authorized distributors or hospital procurement channels. End users usually source directly from licensed pharmaceutical suppliers who comply with regulatory standards.

2. What regulatory approvals do suppliers need to distribute pharmaceutical-grade mannitol?
Suppliers should possess GMP certifications, and their products must meet pharmacopeial standards (USP, EP, JP). They often require regulatory filings in targeted markets, such as FDA approval or European Market Authorization.

3. Are there generic alternatives to OSMITROL available in the market?
Yes, several pharmaceutical companies produce mannitol solutions with equivalent formulations, though branding and excipient profiles may vary. Physicians and pharmacists prefer products with proven manufacturing and regulatory credentials.

4. How does the global supply chain impact the availability of OSMITROL?
Disruptions in raw material sourcing, regulatory delays, or logistical challenges can affect availability. Diversification of suppliers and regional manufacturing can mitigate risks.

5. What should healthcare providers consider when selecting a supplier for OSMITROL?
Providers should verify regulatory compliance, GMP accreditation, product quality, supply reliability, and distributor reputation. Proper documentation and traceability are critical for safe administration.

Sources

[1] Roquette Frères. Pharmaceutical-grade Mannitol. https://www.roquette.com/ingredients/mannitol
[2] Merck KGaA. EMD Millipore Pharmaceuticals Portfolio. https://www.emdmillipore.com/US/en/products/pharmaceutical-raw-materials
[3] MilliporeSigma. Manitol for Injectable Use. https://www.sigmaaldrich.com
[4] AbbVie. OSMITROL product information. https://www.abbvie.com/medical-products/osmitrol.html
[5] U.S. Food and Drug Administration. Pharmaceutical manufacturing standards. https://www.fda.gov

Conclusion

Securing a reliable supply of OSMITROL 10% IN WATER requires engagement with reputable, regulated manufacturers of pharmaceutical-grade mannitol and established distribution channels. With ongoing supply chain reforms and stringent quality standards, healthcare providers and pharmaceutical companies can ensure uninterrupted availability, safeguarding patient care and clinical outcomes.

Suppliers and packagers for OSMITROL 10% IN WATER