Bulk Pharmaceutical API Sources for MANNITOL 15% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for MANNITOL 15% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		HctF@@IaWTfYn~jjj`@@
ZINC		ZINC02041302
Sigma-Aldrich		15719_RIEDEL
Sigma-Aldrich		17781_FLUKA
Sigma-Aldrich		33440_RIEDEL
Sigma-Aldrich		63559_FLUKA

Bulk Active Pharmaceutical Ingredient (API) Sources for: Mannitol 15% in Plastic Container

Last updated: August 5, 2025

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Introduction

Mannitol, a sugar alcohol with widespread use as an osmotic diuretic and excipient in pharmaceutical formulations, demands rigorous quality standards, especially for injectable preparations. A 15% Mannitol solution in plastic containers is commonly utilized in hospital settings, ophthalmic applications, and as a diluent for medication delivery. Ensuring consistent supply hinges on sourcing high-quality bulk API manufacturers with robust manufacturing practices and reliable distribution channels.

This analysis offers an overview of key API suppliers specializing in Mannitol suitable for pharmaceutical preparations, focusing on their manufacturing capabilities, quality compliance, and supply reliability.

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Global API Manufacturers for Mannitol

1. Roquette Frères

Overview:
A leader in specialty ingredients, Roquette has over 80 years of experience producing Mannitol for pharmaceutical and food markets. Their GMP-certified facility ensures compliance with international standards.

Manufacturing & Quality Standards:
Roquette's Mannitol adheres to USP, EP, and JP monographs, with rigorous quality control protocols. Their ability to supply pharmaceutical-grade Mannitol in various forms, including solutions suitable for plastic containers, positions them as a preferred supplier.

Supply Capabilities:
Global distribution network with consistent production capacity ensures timely delivery. The company emphasizes sustainability and quality assurance, critical for injectable and oral use.

Certifications:

• ISO 9001, ISO 13485
• GMP compliance per regional regulatory authorities

Application Suitability:
Their Mannitol is suitable for injectable solutions, including 15% formulations in plastic containers.

2. Roha Dyechem Pvt. Ltd. (India)

Overview:
Specializing in pharmaceutical excipients, Roha offers USP-grade Mannitol with established manufacturing facilities in India, catering to both domestic and export markets.

Manufacturing & Quality Standards:
Roha maintains compliance with GMP and has extensive pharmacopoeia certifications, ensuring pharmaceutical-grade quality.

Supply Capabilities:
Large-scale bulk production with flexible packaging options tailored to customer requirements, including solutions in plastic containers.

Certifications:

• WHO-GMP
• US FDA approvals for export

Application Suitability:
Their Mannitol can meet the quality specifications required for injectable solutions in plastic containers, making it suitable for hospital and clinical use.

3. Merck KGaA (Sigma-Aldrich Portfolio)

Overview:
A global pharmaceutical and chemical supplier, Merck's Sigma-Aldrich division offers high-purity Mannitol APIs designed for research and pharmaceutical manufacturing.

Manufacturing & Quality Standards:
Manufactured under strict GMP conditions, Sigma-Aldrich's Mannitol is traceable, highly pure, and conforms to USP and EP standards.

Supply Capabilities:
Global logistics infrastructure supports steady supply chains, including bulk quantities suitable for injectable formulations.

Certifications:

• ISO 9001, GMP-certified manufacturing facilities

Application Suitability:
Ideal for formulations requiring pharmaceutical-grade Mannitol, including 15% solutions in plastic containers, with verified purity levels.

4. Anhui Fubi Pharmaceutical Co., Ltd. (China)

Overview:
A major Chinese API manufacturer, Fubi Pharmaceutical specializes in sugar alcohols, including Mannitol, offering cost-effective solutions.

Manufacturing & Quality Standards:
Fubi adheres to Chinese GMP standards, with increasing compliance to international norms like USP and EP, supported by third-party testing.

Supply Capabilities:
Capacity for large-scale production and export, with tailored packaging for pharmaceutical use. Their Mannitol API can be formulated into solutions for plastic containers.

Certifications:

• China GMP certification
• Pending or achieved certifications for US and EU regulatory compliance

Application Suitability:
Suitable for formulations where cost-efficiency is critical, with validation needed to confirm compliance with specific regulatory standards.

5. Fosun Pharma / Luye Pharma

Overview:
Fosun and Luye Pharma, Chinese biotech giants, provide APIs including Mannitol, with a focus on quality and supply reliability for global markets.

Manufacturing & Quality Standards:
Fosun's API manufacturing facilities are GMP-certified, with ongoing efforts to align with international standards like ISO and USFDA.

Supply Capabilities:
Established export channels, capable of delivering large quantities, including ready-to-use solutions or bulk APIs for pharmaceutical formulation.

Certifications:

• GMP certification in China
• Demonstration of adherence to international quality standards

Application Suitability:
Fitted for large-volume production of Mannitol solutions, including those packaged in plastic containers for medical use.

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Considerations for Sourcing Mannitol API

Regulatory Compliance:
Choosing suppliers with certifications such as USP, EP, JP, or Food Chemical Codex ensures meeting pharmaceutical quality standards necessary for injectable solutions.

Quality Control & Purity:
High purity specifications (>99%) with Certificate of Analysis (CoA) documentation are critical, particularly for injectable formulations.

Supply Security:
Availability of bulk quantities, reliable delivery timelines, and contingency plans are vital, given the critical medical applications.

Cost and Lead Times:
Balancing quality with price point considerations; Chinese suppliers may offer more competitive pricing but require thorough quality validation.

Environmental and Ethical Standards:
Sustainability practices and adherence to environmental regulations are emerging concerns for global manufacturers.

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Regulatory and Validation Aspects

For pharmaceutical use, the API source must support validation processes, including batch consistency, stability testing, and documentation for regulatory submissions. Suppliers with global GMP certifications streamline registration processes in various jurisdictions.

Key Points:

• Confirm supplier GMP certification before procurement.
• Obtain comprehensive COAs and stability data.
• Conduct supplier audits or third-party audits for compliance verification.

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Conclusion

Securing high-quality Mannitol API suitable for 15% solutions in plastic containers involves evaluating multiple suppliers with proven manufacturing expertise and GMP compliance. Roquette Frères and Sigma-Aldrich stand out for their rigorous quality control and global reach. Indian manufacturers like Roha Pharma offer budget-friendly alternatives, while Chinese firms such as Fubi Pharmaceuticals and Fosun Pharma balance cost with growing international compliance.

An optimal sourcing strategy integrates supplier reliability, quality assurance, regulatory compliance, and logistical capacity to ensure uninterrupted supply and product integrity for medical applications.

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Key Takeaways

• Prioritize suppliers with GMP certification and USP/EP compliance for injectable Mannitol applications.
• Ensure the candidate supplier can deliver large-scale, consistent batches suitable for plastic container formulations.
• Verify traceability and purity levels through detailed Certificates of Analysis.
• Consider geographic diversification to mitigate supply chain disruptions.
• Maintain thorough validation processes when introducing new API sources to adhere to regulatory standards.

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FAQs

1. What are the critical quality attributes to evaluate in Mannitol API for injectable solutions?
   Purity (>99%), batch-to-batch consistency, low moisture content, and compliance with pharmacopoeia standards such as USP or EP.

2. Which regions are leading in Mannitol API manufacturing for pharmaceuticals?
   The United States, Europe, and India lead in pharmaceutical-grade API production, with increasing contributions from China.

3. How does the choice of API supplier impact regulatory approval?
   Suppliers with validated GMP compliance and comprehensive documentation facilitate smoother registration and reduce regulatory risks.

4. Can Mannitol API suppliers provide custom formulations for specific pharmaceutical needs?
   Yes, many reputable manufacturers offer tailored grades and formulations, including solutions suitable for plastic containers.

5. What factors influence the cost of Mannitol API?
   Raw material costs, manufacturing scale, purity requirements, certification standards, and geopolitical factors all impact pricing.

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Sources
[1] Roquette Frères. Product datasheet.
[2] Sigma-Aldrich. Mannitol specifications and certifications.
[3] Chinese GMP and export standards.
[4] Indian Pharmaceutical Excipients Market Report.
[5] Regulatory guidelines: USP and EP monographs.