OSMITROL 10% IN WATER IN PLASTIC CONTAINER: 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 10% 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 10% 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 10% 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 5, 2025

Introduction

The pharmaceutical product OSMITROL 10% in Water in a Plastic Container—generically known as Mannitol 10% solution—serves as an osmotic diuretic primarily used in medical settings for reducing intracranial pressure, intraocular pressure, and managing acute renal failure. As a sterile, parenteral osmotic agent, OSMITROL 10% demands stringent manufacturing standards, particularly for its raw materials, primary packaging, and final sterile formulation. The procurement landscape for this medication involves multiple global suppliers, ranging from active pharmaceutical ingredient (API) producers to finished drug manufacturers and container vendors. This report delineates the key suppliers, their manufacturing capacities, regulatory status, and the dynamics shaping their market presence.

Global Suppliers of OSMITROL 10% (Mannitol) API

1. Roquette Frères (France)
A global leader in plant-based excipients and pharmaceutical ingredients, Roquette supplies high-quality Mannitol API to major pharmaceutical manufacturers worldwide. Their Mannitol is produced through a well-established manufacturing process employing crystalline hydration, guaranteeing high purity and consistent quality. Roquette’s API is widely used in pharmaceutical formulations, including injectables such as OSMITROL 10%. Their manufacturing facilities adhere to Good Manufacturing Practices (GMP), and the company holds active regulatory approvals (e.g., FDA, EMA).

2. SPI Pharma (USA)
SPI Pharma supplies pharmaceutical-grade Mannitol, emphasizing purity and compatibility for parenteral applications. Its manufacturing capabilities include GMP-certified facilities with a focus on excipients and APIs for injectable drugs. SPI Pharma’s Mannitol API is recognized for its high stability, complying with pharmacopeial standards suitable for parenteral solutions like OSMITROL 10%.

3. Merck KGaA (Germany)
A historic supplier, Merck produces pharmaceutical-grade Mannitol used in both solid and liquid formulations. Their manufacturing facilities follow stringent quality controls, and their products are approved across extensive regulatory jurisdictions. Merck supplies Mannitol API globally, often as an excipient but also as a raw material for injectable osmotic solutions.

4. Gates Corporation (USA)
Gates provides premium-grade Mannitol suitable for parenteral use, emphasizing high purity and low endotoxin levels. Their API production facilities are certified under GMP, and their products conform to pharmacopoeial standards, making them a reputable choice for OSMITROL manufacturing.

5. Others and Regional Suppliers
Besides these major players, regional producers in India, China, and Eastern Europe—such as VNC Pharma (India) and Hengrui Medicine (China)—offer Mannitol API at competitive prices. These suppliers often serve local markets but are increasingly sought after for global export amid cost-competitiveness.

Manufacturers of Finished OSMITROL 10% in Water in Plastic Containers

1. BioMed (USA)
BioMed is a primary manufacturer of methamphetamine, but also produces sterile injectable solutions like OSMITROL, adhering to strict GMP standards, with packaging in suitable plastic containers considering compatibility and stability.

2. Fresenius Kabi (Germany)
Fresenius Kabi specializes in sterile parenteral solutions, including Mannitol-based products. They manufacture OSMITROL with robust quality systems, conforming to pharmacopoeial monographs, and often utilize polyolefin containers that are compatible with osmotic solutions.

3. Hospira (USA, now part of Pfizer)
A key global supplier, Hospira offers sterile water-based formulations of Mannitol, supplied in pre-sterilized, optimized plastic containers, ensuring batch-to-batch consistency.

4. Local and Regional Manufacturers
Numerous regional manufacturers in India (e.g., Sun Pharma, Cipla), China, and Eastern Europe produce licensed forms of Mannitol solutions, catering primarily to domestic markets but also exported under strict regulatory clearance.

Plastic Container Suppliers for OSMITROL 10%

The container material plays a critical role in maintaining drug stability, preventing leaching, and ensuring compatibility. Major plastic container suppliers include:

1. Gerresheimer AG (Germany)
Specializes in pharmaceutical-grade plastic containers—particularly blow-molded and injection-molded bottles made of polypropylene (PP) and cyclic olefin copolymer (COC). Their containers are widely used in parenteral solutions.

2. Schott AG (Germany)
While renowned for glass, Schott also manufactures high-quality plastic containers suitable for aqueous solutions. Their focus is on chemical inertness and barrier properties.

3. Nipro Corporation (Japan)
Offers a broad range of plastic bottles designed specifically for injectable solutions, emphasizing safety, compatibility, and regulatory compliance.

4. Local Container Manufacturers
Emerging regional providers, especially in India and China, supply polypropylene bottles and compatible closures, often competing on price but subject to rigorous quality control requirements.

Regulatory Considerations and Certification

Suppliers must comply with international standards, including GMP, ISO, and pharmacopeial specifications (USP, EP, JP). Vendors with multiple regulatory approvals (FDA, EMA) hold competitive advantage, especially for products intended for markets with stringent safety and quality standards. For OSMITROL 10%, the integrity of raw materials and final packaging integrity are critically scrutinized during regulatory inspections and audits.

Market Dynamics

The supply chain for OSMITROL 10% is characterized by:

Global API Consolidation: Major API producers dominate, with supply chains consolidating around high-volume, compliant manufacturers.
Regional Cost Pressures: Indian and Chinese manufacturers provide cost-effective options, but with increasing emphasis on quality certification.
Packaging Innovations: As container technology advances, suppliers invest in barrier plastics and elastomer closures to enhance stability.
Regulatory Stringency: Approval processes and audits impact supplier selection, favoring companies with proven regulatory track records.

Conclusion

The procurement of OSMITROL 10% in water in plastic containers involves a diverse network of suppliers across the API, finished formulation, and container segments. Leading API suppliers like Roquette and Merck are preferred for their high quality and regulatory compliance. Finished product manufacturers such as Fresenius Kabi and Hospira offer reliable sterile solutions, often sourcing components globally. Plastic container providers, notably Gerresheimer and Nipro, ensure container compatibility and stability.

To mitigate supply risks, pharmaceutical companies should establish multi-source agreements, verify regulatory compliance, and regularly audit suppliers to ensure continuity and compliance within their supply chain.

Key Takeaways

Major API suppliers include Roquette, SPI Pharma, and Merck, with regional suppliers emerging from India and China.
Finished OSMITROL products are manufactured by leading companies like Fresenius Kabi, with regional manufacturers offering competitive alternatives.
Plastic container sourcing emphasizes compatibility, barrier properties, and compliance, with vendors such as Gerresheimer and Nipro leading the market.
Regulatory approval and GMP certification are essential criteria for supplier selection in the sterile injectable segment.
Implementing robust supplier qualification programs and diversifying sources mitigate supply chain disruptions and ensure product quality.

FAQs

1. What are the key criteria for selecting an API supplier for Mannitol used in OSMITROL 10%?
Regulatory compliance (GMP, FDA, EMA approvals), purity standards, consistent quality, supply capacity, and logistical reliability.

2. How do container materials impact the stability of OSMITROL 10% formulations?
Container materials like polypropylene or cyclic olefin copolymer ensure chemical inertness, prevent leaching, and maintain osmotic solution stability over its shelf life.

3. Are regional suppliers of Mannitol API compliant with international standards?
Some regional suppliers meet international standards, but rigorous qualification, auditing, and validation are necessary before qualification.

4. What regulatory approvals should suppliers possess for global distribution?
Suppliers should hold GMP certification, and approvals from agencies such as the FDA, EMA, and WHO prequalification are highly advantageous.

5. How does the choice of plastic container supplier influence product quality?
It affects drug stability, sterility assurance, process compatibility, and regulatory compliance, directly impacting product safety and efficacy.

Sources

[1] Roquette Official Website. Pharma Ingredients Portfolio.
[2] SPI Pharma Product Listings.
[3] Merck KGaA Pharmaceutical Products.
[4] Gerresheimer AG Pharmaceutical Packaging Solutions.
[5] European Pharmacopoeia Monographs on Mannitol and Injectable Solutions.

Suppliers and packagers for OSMITROL 10% IN WATER IN PLASTIC CONTAINER