Bulk Pharmaceutical API Sources for MANNITOL 15%

Bulk Pharmaceutical API Sources for MANNITOL 15%

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		HctF@@IaWTfYn~jjj`@@
Sigma-Aldrich		M1902_SIGMA
Sigma-Aldrich		M4125_SIAL

Bulk Active Pharmaceutical Ingredient (API) Sources for Mannitol 15%

Last updated: July 30, 2025

Introduction

Mannitol, a sugar alcohol with pharmaceutical and industrial applications, is commonly used in intravenous therapy, as a carrier in pharmaceutical formulations, and as a diuretic in medical practice. Its 15% solution form is widely employed in medical settings for osmotic diuresis, reduction of intracranial pressure, and ocular surgeries. Ensuring reliable procurement of high-quality Mannitol APIs is critical for pharmaceutical manufacturers, hospitals, and research institutions. This article delineates key sources of bulk Mannitol 15% API, evaluates their credibility, geographic distribution, regulatory compliance, and supply reliability.

Overview of Mannitol API Market

The global Mannitol API market is characterized by a handful of large-scale producers, primarily based in China, India, and converting units in Europe and the United States. The supply chain involves complex manufacturing processes, including hydrogenation of D-glucose, purification, and crystallization, requiring strict adherence to Good Manufacturing Practices (GMP). Regulatory approval, such as from the FDA, EMA, or the Chinese NMPA, is fundamental for market acceptance, especially in pharmaceutical and clinical settings.

Major API Suppliers for Mannitol 15%

1. Anhui Fuer Food Additive Co., Ltd. (China)

Anhui Fuer is a prominent manufacturer offering bulk Mannitol API compliant with international pharmaceutical standards, including Pharmacopeia specifications. The company specializes in carbohydrate derivatives and supplies Mannitol with high purity (≥99%) for injectable and ophthalmic use.

• Strengths: Competitive pricing, extensive experience, GMP-certified manufacturing, and strict quality control.
• Certifications: ISO 9001, ISO 14001, with FDA and NMPA registration for certain export markets.
• Supply Reliability: Regular production runs with consistent quality; long-standing supplier with established logistics channels.

2. Roquette Frères (France)

A globally recognized leader in plant-based ingredients, Roquette manufactures pharmaceutical-grade Mannitol API for various formulations.

• Strengths: High-quality standards, extensive R&D, and global distribution network.
• Certifications: GMP, ISO, and adherence to EU and U.S. pharmacopeia standards.
• Supply Reliability: Reliable, large-scale production with dedicated supply chains for pharmaceuticals.

3. Merck KGaA (Germany)

Merck supplies Mannitol API as part of their broad portfolio of pharmaceutical excipients and active ingredients.

• Strengths: Proven quality, advanced purification processes, and compliance with international standards.
• Certifications: GMP, ISO, and regulatory approvals for key markets.
• Supply Reliability: High-volume production, with a focus on consistent delivery and safety.

4. Shanghai Sunway Biotech Co., Ltd. (China)

Specializing in carbohydrate-based APIs, Shanghai Sunway supplies Mannitol with a focus on pharmaceutical-grade applications.

• Strengths: Cost-effective, GMP-certified, and capable of custom specifications.
• Certifications: GMP, ISO 9001.
• Supply Reliability: Established manufacturing capacity, with a significant export record.

5. Wacker Chemie AG (Germany)

Known for specialty chemicals, Wacker offers pharmaceutical-grade Mannitol suitable for injectable use and parenteral formulations.

• Strengths: High purity standards, rigorous quality control, and compliance with global regulatory frameworks.
• Certifications: GMP, ISO 9001/ISO 14001.
• Supply Reliability: Stable global supply, backed by Wacker’s industrial infrastructure.

Regional Breakdown and Key Considerations

Asia-Pacific

Asia dominates Mannitol production, primarily through China and India owing to lower manufacturing costs and expanding capacities. Chinese suppliers like Anhui Fuer and Shanghai Sunway offer competitive prices and flexible OEM services. However, regulatory compliance and quality assurance are paramount given regional variability.

Europe

European suppliers such as Roquette and Wacker emphasize quality, regulatory compliance, and R&D, making their APIs preferable for highly regulated markets. Their products typically undergo extensive certification, enabling seamless integration into pharmaceutical formulations worldwide.

North America

North American procurement relies heavily on European suppliers, as domestic API production for Mannitol remains limited. Merck's presence offers an advantage through its regional distribution network, ensuring supply security aligned with FDA regulations.

Regulatory and Quality Considerations

Pharmaceutical applications demand APIs that meet pharmacopeia standards (USP, EP, JP). Suppliers with documented GMP compliance, validated manufacturing processes, and rigorous quality control systems are essential. Importantly, verification of Certificates of Analysis (CoA), stability data, and regulatory approvals enhances supply chain integrity.

Supply Chain Dynamics and Challenges

The supply of Mannitol API faces fluctuations due to raw material availability, geopolitical factors, and global disruptions such as pandemics. Suppliers with diversified manufacturing facilities and contingency strategies—such as inventory buffers—offer better supply security. Additionally, companies with certified quality management systems minimize the risk of regulatory non-compliance.

Conclusion

Securing a reliable source of Mannitol 15% API necessitates evaluating supplier authenticity, regulatory compliance, manufacturing capacity, and supply stability. Leading global suppliers like Roquette, Merck, and Wacker provide high-quality APIs suitable for pharmaceutical applications and possess robust supply chains. Chinese manufacturers, such as Anhui Fuer and Shanghai Sunway, offer competitively priced options with sufficient quality assurance for non-regulated or semi-regulated markets. Strategic procurement should balance cost, regulatory needs, and supply reliability to ensure continuous production and compliance.

Key Takeaways

• Leading pharmaceutical-grade Mannitol API suppliers include Roquette, Merck, and Wacker, known for high-quality standards and domestic or regional distribution.
• Chinese manufacturers like Anhui Fuer and Shanghai Sunway are key sources in the Asia-Pacific region, offering cost-effective options with GMP certifications.
• Regulatory compliance, such as GMP and pharmacopeia standards, is critical for API selection in pharmaceutical manufacturing.
• Supply chain resilience hinges on supplier diversification, regulatory adherence, and contingency planning amid global disruptions.
• Close communication, verified documentation, and comprehensive quality control are essential for securing a reliable Mannitol API supply.

FAQs

Q1: What factors should I consider when selecting a Mannitol API supplier?
A: Focus on GMP compliance, product purity (>99%), regulatory approvals (FDA, EMA, NMPA), manufacturing capacity, supply reliability, and price competitiveness.

Q2: Are Chinese Mannitol API suppliers suitable for pharmaceutical-grade applications?
A: Yes, many Chinese suppliers produce GMP-certified Mannitol API meeting international pharmacopeia standards, though verification of certifications is essential.

Q3: How does Mannitol API quality impact pharmaceutical formulations?
A: High-purity, well-regulated APIs ensure safety, efficacy, and regulatory compliance of finished pharmaceutical products.

Q4: What risks exist in the Mannitol API supply chain?
A: Risks include raw material shortages, geopolitical tensions, logistic disruptions, and non-compliance with regulatory standards.

Q5: How can I ensure the authenticity of API documentation?
A: Verify Certificates of Analysis, third-party testing results, and conduct supplier audits or inspections to confirm authenticity and quality.

References

[1] Market research reports on Mannitol API (2022).
[2] Regulatory guidelines for pharmaceutical APIs (FDA, EMA).
[3] Industry certifications and standards documentation.