Bulk Pharmaceutical API Sources for OSMITROL 10% IN WATER IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for OSMITROL 10% IN WATER IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M1902_SIGMA
Sigma-Aldrich		M4125_SIAL
Sigma-Aldrich		M8429_SIAL
Sigma-Aldrich		M9546_SIAL
Sigma-Aldrich		M9647_SIAL

Bulk Active Pharmaceutical Ingredient (API) Sources for OSMITROL 10% in Water in Plastic Container

Last updated: August 5, 2025

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Introduction

Osmitrol (mannitol) is an osmotically active agent used primarily in medical settings for intracranial pressure management, ocular surgeries, and as a diuretic. The formulation of OSMITROL 10% in water in plastic containers requires sourcing high-quality bulk Active Pharmaceutical Ingredient (API) that complies with stringent pharmaceutical standards. This report explores key bulk API sources suitable for manufacturing OSMITROL 10%, considering quality, regulatory compliance, and market availability.

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Regulatory and Quality Considerations

When selecting API suppliers for injectable formulations like OSMITROL 10%, adherence to Good Manufacturing Practices (GMP) mandated by agencies such as the FDA, EMA, or equivalent local authorities is critical. APIs must meet pharmacopeial standards, such as the USP (United States Pharmacopeia), EP (European Pharmacopoeia), or JP (Japanese Pharmacopoeia). Consistent supply, validated quality controls, and documented compliance underpin reliable production.

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Global API Manufacturers for Mannitol

1. Roquette Frères

• Overview: A leading global supplier of pharmaceutical-grade excipients and APIs, Roquette is known for its high-quality mannitol products, including crystalline forms suitable for injectables.
• Product Offerings: USP-grade Mannitol (USP/NF grade). Their product meets rigorous pharmacopeial standards.
• Quality Certifications: GMP, ISO 9001, and other international certifications.
• Supply Capabilities: Large-scale manufacturing with extensive export experience to the pharmaceutical industry worldwide.

2. Merck KGaA (EMD Millipore)

• Overview: Merck offers pharmaceutical-grade mannitol suitable for parenteral use, with a focus on purity and low endotoxin levels.
• Product Offerings: Mannitol USP/EP grades, suitable for injectable formulations.
• Quality Certifications: GMP certification, adherence to pharmacopeial standards.
• Advantages: Proven track record in supplying high-quality APIs for clinical and commercial use.

3. Thermo Fisher Scientific (formerly Fisher Scientific)

• Overview: Offers pharmaceutical-grade mannitol, including grades compatible with injection requirements.
• Product Offerings: Mannitol pharmaceutical-grade powders that meet USP and other pharmacopeial standards.
• Certifications: GMP, ISO, and comprehensive analytical documentation.
• Supply Chain: Global distribution network facilitates timely delivery.

4. Sigma-Aldrich (Part of Merck Group)

• Overview: A reputable supplier of pharmaceutical-grade raw materials, including highly pure mannitol.
• Product Offerings: USP and EP grade mannitol suitable for injection.
• Quality: Batch-specific analytical data, stability, and endotoxin testing.
• Market Presence: Extensive catalog supporting pharmaceutical manufacturing.

5. Tianjin Jiuri New Material Co., Ltd.

• Overview: A Chinese manufacturer specializing in pharmaceutical excipients and APIs, including mannitol.
• Product Offerings: Pharmaceutical-grade mannitol in bulk quantities conforming to Chinese Pharmacopeia (ChP), USP, or EP standards.
• Certifications: GMP certification, export licenses.
• Market Position: Cost-competitive sourcing with rapid supply capabilities, increasingly accepted in international markets.

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Regional Considerations

• North America & Europe: Regulatory compliance is strict, favoring suppliers like Roquette, Merck, Thermo Fisher, and Sigma-Aldrich.
• Asia-Pacific: Growing acceptance of Chinese suppliers like Tianjin Jiuri, provided they meet regulatory requirements and provide necessary documentation.
• Emerging Markets: Local suppliers can offer cost advantages, but validation of quality standards is essential.

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Selecting the Right Supplier

Key factors include:

• Regulatory compliance: Ensure suppliers hold GMP certification and provide Certificate of Analysis (CoA) matching pharmacopeial standards.
• Quality attributes: Purity (>99%), endotoxin levels, residual solvents, particle size distribution.
• Supply capacity and consistency: Ability to meet production demands with batch-to-batch uniformity.
• Documentation: Comprehensive analytical data, stability studies, and regulatory dossiers.
• Cost and logistics: Competitive pricing aligned with quality and reliable delivery schedules.

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Conclusion

The sourcing of bulk API for OSMITROL 10% in water in plastic containers hinges on selecting reputable manufacturers that guarantee high purity, consistent quality, and compliance with global pharmacopeial standards. Leading global suppliers such as Roquette, Merck, Thermo Fisher, and Sigma-Aldrich remain primary choices in developed markets, while Chinese manufacturers like Tianjin Jiuri expand options for cost-sensitive projects. Ensuring meticulous evaluation of quality certificates and regulatory adherence is critical to maintaining product integrity throughout manufacturing.

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Key Takeaways

• Prioritize suppliers with GMP certification and proven compliance with pharmacopeial standards.
• Consider regional supply options aligned with regulatory demands.
• Validate API quality through comprehensive analytical documentation before qualifying for use.
• Maintain vendor audits and periodic reevaluation to ensure continuous quality assurance.
• Factor in cost, supply reliability, and logistical considerations alongside quality metrics.

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FAQs

1. What regulatory standards should API suppliers meet for injectable mannitol?
Suppliers should provide API conforming to USP, EP, or other relevant pharmacopeial standards, with GMP certification and comprehensive documentation confirming purity, endotoxin levels, and residual solvent limits.

2. Can I source mannitol from Chinese manufacturers for pharmaceutical use?
Yes, several Chinese manufacturers, such as Tianjin Jiuri, supply pharmaceutical-grade mannitol meeting international standards. Due diligence, including audits and documentation review, is essential to ensure compliance.

3. How important is endotoxin testing for API used in injections?
Extremely critical. Endotoxin levels must be below specified limits to prevent pyrogenic reactions. Suppliers should provide endotoxin testing certificates with each batch.

4. What should be included in the Certificate of Analysis (CoA) when qualifying a new API batch?
The CoA should include detailed specifications such as assay (purity), moisture content, particle size distribution, residual solvents, microbial limits, endotoxin levels, and stability data.

5. What are the risks of sourcing low-quality API for injectable formulations?
Using substandard API can lead to poor product efficacy, safety issues, regulatory non-compliance, product recalls, and damage to brand reputation.

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References

1. [1] USP <1171> Pharmaceutical Calculations, USP 43 - NF 38, 2020.
2. [2] European Pharmacopoeia 10th Edition, 2020.
3. [3] "Mannitol," Merck KGaA, Product Documentation.
4. [4] Roquette France – Pharmaceutical Ingredients Catalogue.
5. [5] Tianjin Jiuri New Material Co., Ltd. Official Website and Certifications.