Last updated: August 3, 2025
Introduction
Mannitol 10% in plastic containers is a widely used pharmaceutical agent primarily employed as a diuretic, osmotic agent, and excipient in various medical formulations. Its applications extend from reducing intracranial pressure to serving as a stabilizer in drug formulations. Given its extensive use, securing reliable suppliers with high-quality standards and consistent supply chains is critical for pharmaceutical companies, hospitals, and compounding pharmacies.
Overview of Mannitol 10% in Plastic Containers
Mannitol is a sugar alcohol with cryoprotective and osmotic properties. The 10% concentration in plastic containers—typically polyethylene or polypropylene—facilitates ease of handling, sterilization, and administration. Manufacturers often source this formulation from specialized pharmaceutical-grade raw materials and employ stringent quality control measures to meet pharmacopeial standards such as USP, EP, or JP.
Key Attributes of Suppliers
- Regulatory Compliance: Good Manufacturing Practice (GMP) adherence, ISO certifications, and compliance with pharmacopeial standards.
- Quality Assurance: Use of high-purity raw materials, reliable sterilization processes, and validated filling procedures.
- Supply Capacity: Ability to meet varying order quantities promptly.
- Distribution Network: Global reach and efficient logistics to minimize lead times.
- Pricing and Contract Flexibility: Competitive pricing models and adaptable contractual terms.
Major Global Suppliers
1. Fresenius Kabi
- Overview: A leading global provider specializing in infusion solutions and injectable drugs.
- Product Portfolio: Offers Mannitol 10% in sterile, pre-filled plastic containers.
- Certifications: GMP, ISO 13485, and other regulatory compliances.
- Strengths: Extensive manufacturing capacity, robust supply chain, and comprehensive quality management.
2. Baxter International Inc.
- Overview: A multinational healthcare company with a focus on sterile pharmaceutical solutions.
- Product Offerings: Mannitol solutions available in various concentrations within plastic containers suitable for infusion.
- Compliance: Meets global regulatory standards including FDA and EU standards.
- Strengths: Strong distribution channels and established reputation for high-quality products.
3. Hospira (A Pfizer Company)
- Overview: Specializes in sterile injectable drugs, including Mannitol formulations.
- Product Features: Pre-filled plastic container options with high sterility assurance.
- Regulatory Compliance: Fully compliant with global regulations, including PED and GMP.
- Strengths: Proven reliability and extensive product testing protocols.
4. B. Braun Melsungen AG
- Overview: A prominent provider of infusion therapy products.
- Product Line: Mannitol 10% solutions in plastic containers manufactured under strict quality guidelines.
- Certifications: GMP, ISO, and adherence to pharmacopeial standards.
- Strengths: Innovation in container technology and consistent product quality.
5. Sigma-Tau (Part of Stevanato Group)
- Overview: Manufactures high-quality sterile solutions, including Mannitol.
- Specialties: Focus on container design optimized for stability and safety.
- Certifications: GMP, ISO 9001.
- Strengths: Flexible manufacturing options and integrated supply chain.
Regional Suppliers and Considerations
Apart from global giants, regional manufacturers often serve local markets with competitive pricing and tailored supply agreements. Examples include:
- Fresenius Kabi India: Supplies Mannitol in plastic containers suitable for the Indian subcontinent.
- Hengshui Longliqi Pharmaceutical Co., Ltd. (China): Produces Mannitol solutions with a focus on Asian markets.
- Medreich (India): Offers affordable Mannitol formulations compliant with international standards.
When selecting regional suppliers, ensure they hold relevant certifications such as WHO-GMP, ISO 9001, and regional regulatory approvals (e.g., CDSCO in India).
Criteria for Selecting a Supplier
- Regulatory Status: Confirm approvals from relevant agencies (FDA, EMA, PMDA, etc.).
- Manufacturing Quality: Audit manufacturing facilities or review third-party audit reports.
- Traceability: Ensure batch traceability and robust documentation.
- Stability Data: Review shelf-life, storage, and container compatibility.
- Customer Service: Evaluate responsiveness, technical support, and supply chain resilience.
Emerging Trends and Supply Chain Considerations
- Consolidation of Suppliers: Many pharmaceutical companies are consolidating supplier lists for quality assurance and reduced complexity.
- Container Technologies: Advances in container materials (e.g., stability-enhanced plastics) improve drug stability.
- Supply Chain Disruptions: Recent global events emphasize the need for diversified sourcing and contingency planning.
Conclusion
The procurement of Mannitol 10% in plastic containers necessitates due diligence in selecting suppliers that uphold strict quality standards and can ensure steady supply. Industry leaders such as Fresenius Kabi, Baxter, Hospira, B. Braun, and Stevanato Group offer reliable options globally. Regional manufacturers complement these offerings with localized solutions, often at more competitive prices, provided they meet regulatory and quality thresholds.
Key Takeaways
- Choose suppliers with proven GMP compliance, extensive regulatory approvals, and proven manufacturing excellence.
- Evaluate supplier capabilities regarding supply capacity, distribution networks, and contingency planning.
- Consider emerging container technologies that enhance product stability and safety.
- Conduct thorough audits or reviews of manufacturing facilities and quality documentation.
- Diversify suppliers to mitigate risks posed by global supply chain disruptions.
FAQs
1. How can I verify the quality standards of a Mannitol supplier?
Verify regulatory certifications (GMP, ISO), review batch testing reports, demand third-party audit reports, and confirm compliance with pharmacopeial standards (USP, EP, JP).
2. Are regional suppliers suitable for pharmaceutical-grade Mannitol?
Yes, provided they meet international quality requirements, hold proper certifications, and have a proven track record in producing sterile solutions under GMP conditions.
3. What are the key factors influencing the price of Mannitol 10% in plastic containers?
Raw material costs, manufacturing scale, container technology, regulatory compliance, supply chain efficiency, and contractual terms significantly influence pricing.
4. Can Mannitol formulations in plastic containers be customized?
Yes, manufacturers often offer customization options such as container size, closure systems, and sterile fill volumes to meet specific clinical or institutional needs.
5. How has supply chain stability impacted Mannitol availability recently?
Global disruptions, including those caused by COVID-19, have occasionally led to shortages; hence, diversified sourcing and inventory management are vital.
Sources:
- USP Expert Committee. United States Pharmacopeia Monograph for Mannitol. USP 41. 2018.
- European Pharmacopoeia. Mannitol Monograph. EP 10.0.
- B. Braun. Product Catalog – Infusion Solutions.
- Fresenius Kabi. Product Data Sheets.
- Baxter International. Sterile Injectable Solutions.
