Bulk Pharmaceutical API Sources for MANNITOL 10% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for MANNITOL 10% 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
Sigma-Aldrich		63560_FLUKA

Bulk Active Pharmaceutical Ingredient (API) Sources for: Mannitol 10% in Plastic Container

Last updated: August 4, 2025

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Introduction

The pharmaceutical industry relies heavily on the steady and reliable supply of Active Pharmaceutical Ingredients (APIs), which are pivotal in drug formulation and therapy. Mannitol, a sugar alcohol widely used as an osmotic diuretic and excipient, is commonly prepared as a sterile solution for medical applications, including intravenous administration. Specifically, Mannitol 10% solutions packaged in plastic containers are critical in various clinical settings. This analysis explores the global sources of bulk Mannitol suitable for such formulations, emphasizing manufacturing capabilities, quality standards, and supply chain considerations essential for pharmaceutical stakeholders.

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Overview of Mannitol as an API

Mannitol (C₆H₁₄O₆) functions primarily as an osmotic diuretic, and in pharmaceutical formulations, it serves as a filler, stabilizer, and osmotic agent. Pharmaceutical-grade Mannitol must meet stringent specifications, including purity levels (typically ≥99.0%), low endotoxin content, and compliance with pharmacopeial standards such as USP, EP, or JP.

For injectable solutions like Mannitol 10%, compliance with sterile manufacturing conditions and container compatibility is non-negotiable. The API's sourcing involves manufacturers with robust Good Manufacturing Practice (GMP) certifications, ensuring reliable quality and regulatory approval pathways.

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Key Global Sources of Mannitol API

1. China

Leading Supplier: Jilin Qifeng Biological Technology Co., Ltd.

• Manufacturing Capabilities: Specializes in pharmaceutical-grade Mannitol with GMP certification, producing both bulk powder and solution forms. Their facilities are compliant with Chinese SFDA standards and possess international accreditations, facilitating exports to regulated markets.
• Supply Reliability: Strong manufacturing capacity, with consistent production volumes meeting global demand.
• Quality Standards: Meets USP, EP, and JP specifications, alongside additional certifications like ISO 9001 and ISO 13485.

Market Position: China remains the dominant source of pharmaceutical-grade Mannitol due to high production volumes and cost competitiveness.

2. India

Leading Supplier: Sanofi India Ltd. / Fosun Pharma

• Manufacturing Capabilities: Indian firms like Sun Pharma and Piramal Pharma Solutions produce medicinal-grade Mannitol, adhering to cGMP protocols.
• Supply Reliability: Substantial manufacturing infrastructure enabling large-volume exports.
• Quality Assurance: Certified within the regulatory frameworks of Indian and international agencies, producing Mannitol in compliance with global pharmacopeias.

Market Position: India's API industry benefits from rigorous quality controls and cost advantages, increasing its prominence.

3. United States

Leading Supplier: Merck KGaA (via MilliporeSigma)

• Manufacturing Capabilities: Produces pharmaceutical-grade Mannitol for sterile parenteral solutions, validated for high purity and endotoxin levels.
• Supply Reliability: Focused on high-quality, compliant APIs with dedicated sterile facility infrastructure.
• Quality Standards: Meets USP and EP standards, with extensive documentation suitable for U.S. and European markets.

Market Position: The US suppliers are preferred for high-end, sterile, and highly regulated applications, especially in North America and Europe.

4. Europe

Leading Supplier: BioVendor (Czech Republic)

• Manufacturing Capabilities: Offers GMP-certified Mannitol, including solutions suitable for injectable formulations.
• Supply Reliability: Recognized for consistent supply chain and adherence to strict EU regulatory standards.
• Quality Assurance: Compliant with European Pharmacopoeia standards, facilitating seamless integration into European healthcare systems.

5. Other Notable Sources

• Russia: Pharmstandard produces pharmacopeial Mannitol, primarily for regional markets, with growing export capabilities.
• Japan: Mochida Pharmaceutical and other Japanese firms supply high-quality Mannitol API, primarily for regional use, with strict adherence to pharmacopeial and ISO standards.

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Supply Chain and Regulatory Considerations

• Quality Certification: For injectable Mannitol 10%, sourcing from GMP-compliant manufacturers is mandatory. International certifiers such as PIC/S, EMA, and FDA inspections certify manufacturing processes.
• Endotoxin and Sterility Certification: Ensuring low endotoxin levels (<0.25 EU/mL) and sterility is critical for solutions administered intravenously.
• Raw Material Traceability: Suppliers offering comprehensive documentation, batch consistency, and stability data facilitate regulatory approval.
• Global Logistics: The global API market is influenced by geopolitical factors, trade policies, and logistical capacities, affecting supply chain stability and pricing.

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Emerging Trends and Future Outlook

• Regional Expansion: Countries like India and China continue expanding GMP-certified manufacturing, adding capacity for sterile API production.
• Supply Chain Diversification: Pharmaceutical companies increasingly seek diversified sources to mitigate risks associated with supply disruptions.
• Regulatory Evolution: Increasing harmonization of pharmacopeial standards and stricter quality controls enhance the reliability of API sourcing, especially for sterile solutions.

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Conclusion

The primary sources of bulk Mannitol API suitable for 10% solutions in plastic containers span across China, India, Europe, and North America. Each region provides distinct advantages regarding capacity, quality, and regulatory compliance. Pharmaceutical companies must prioritize suppliers with strong GMP credentials, compliance with pharmacopeial standards, and proven sterility assurance for injectable applications. Strategic sourcing, coupled with vigilant quality assurance, mitigates risks and ensures uninterrupted supply of this critical API.

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Key Takeaways

• Diverse Global Sources: China and India dominate bulk Mannitol supply, with capable suppliers offering pharmaceutical-grade, GMP-compliant APIs.
• Quality & Compliance: For injectable Mannitol, adherence to stringent GMP, endotoxin, and sterility standards is essential.
• Supply Chain Resilience: Diversification of sources reduces vulnerabilities caused by geopolitical or logistical disruptions.
• Regulatory Alignment: Suppliers with certifications aligned to target markets’ pharmacopoeias (USP, EP, JP) streamline regulatory approval.
• Market Dynamics: Emerging capacities and increased regulatory scrutiny are shaping the future landscape of Mannitol API sourcing.

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FAQs

1. What quality standards should I verify when sourcing Mannitol API for intravenous use?
Ensure the API complies with pharmacopeial standards (USP, EP, JP), with documentation confirming endotoxin levels (<0.25 EU/mL), sterility, and GMP certification.

2. Which regions are most reliable for sourcing pharmaceutical-grade Mannitol?
China, India, Europe, and North America are the primary regions, with established GMP-certified manufacturers that provide high-quality, reliable supply chains.

3. How does pricing differ among global Mannitol API suppliers?
Prices vary based on manufacturing costs, scale, quality certifications, and logistical factors. China and India typically offer more cost-effective options, while Europe and the US prioritize strict quality standards, potentially at higher costs.

4. Are there certifications that facilitate international acceptance of Mannitol API?
Yes. Certifications such as GMP, ISO 9001, ISO 13485, PIC/S registration, and adherence to Pharmacopeial standards enable acceptance across regulatory jurisdictions.

5. What trends are influencing the future supply of Mannitol API?
Growing demand for sterile, high-purity APIs, increased capacity from emerging markets, and stricter regulatory standards are shaping the future supply landscape.

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Sources

[1] USP – United States Pharmacopeia. (2022). https://www.usp.org
[2] European Pharmacopoeia Commission. (2022). https://www.edqm.eu
[3] World Health Organization. (2021). Pharmaceutical manufacturing standards.
[4] GMP Certification Bodies. (2022). https://www.gmpcert.org
[5] Market reports on API manufacturing. (2023). IQVIA, EvaluatePharma.