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Suppliers and packagers for MANNITOL 25%
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MANNITOL 25%
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | MANNITOL 25% | mannitol | INJECTABLE;INJECTION | 080677 | ANDA | Fresenius Kabi USA, LLC | 63323-024-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-024-25) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-024-01) | 2000-03-19 |
| Fresenius Kabi Usa | MANNITOL 25% | mannitol | INJECTABLE;INJECTION | 080677 | ANDA | ProPharma Distribution | 84549-024-25 | 50 mL in 1 VIAL, SINGLE-DOSE (84549-024-25) | 2000-03-19 |
| Hospira | MANNITOL 25% | mannitol | INJECTABLE;INJECTION | 016269 | NDA | Henry Schein, Inc. | 0404-9905-50 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9905-50) / 50 mL in 1 VIAL, SINGLE-DOSE | 2022-01-12 |
| Hospira | MANNITOL 25% | mannitol | INJECTABLE;INJECTION | 016269 | NDA | Hospira, Inc. | 0409-4031-01 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4031-01) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-4031-16) | 2004-11-30 |
| Hospira | MANNITOL 25% | mannitol | INJECTABLE;INJECTION | 016269 | NDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1468-1 | 50 mL in 1 VIAL, SINGLE-DOSE (51662-1468-1) | 2019-12-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Mannitol 25%
Introduction
Mannitol 25% is a widely used pharmaceutical excipient and active pharmaceutical ingredient (API), primarily recognized for its osmotic diuretic and neuroprotective properties. It serves in various medical applications, including intracranial pressure reduction, renal failure management, and as a component in intravenous solutions. A robust supply chain for Mannitol 25% is critical for pharmaceutical manufacturers, hospitals, and medical institutions worldwide. This report delineates the leading suppliers, market dynamics, regulatory landscape, and strategic considerations for sourcing Mannitol 25%.
Overview of Mannitol 25%
Mannitol is a sugar alcohol derived through the hydrogenation of mannose or from raw materials like starch and molasses. When formulated as a 25% solution, it provides a clear, sterilizable solution suitable for intravenous administration. It is manufactured under strict Good Manufacturing Practice (GMP) standards, ensuring high purity, stability, and bioavailability.
The global demand for Mannitol 25% is driven largely by hospitals, dialysis centers, and pharmaceutical companies producing infusion solutions. The compound's production requires specialized plants capable of handling chemical synthesis and sterilization processes, creating potential bottlenecks and competitive barriers in supply.
Leading Global Suppliers of Mannitol 25%
1. Roquette Company
Overview:
Roquette, a French global leader in plant-based ingredients, is one of the most prominent suppliers of pharmaceutical-grade Mannitol. Their product offerings include Mannitol for pharmaceutical, food, cosmetic, and industrial applications.
Capabilities & Market Position:
Roquette’s Mannitol is produced in high-quality GMP-compliant facilities, offering consistent batches. The company emphasizes sustainability and product purity, and its global footprint includes manufacturing sites in Europe, Asia, and North America, facilitating reliable supply chains for customers worldwide.
Certifications & Regulatory Compliance:
Roquette’s Mannitol 25% solutions are approved by major regulatory agencies, including the FDA and EMA, ensuring compliance with pharmacopoeial standards.
2. Merck KGaA (Euriso-top)
Overview:
Merck Group, through its Euriso-top division, supplies pharmaceutical and industrial-grade Mannitol. Their supply chain encompasses both bulk powder and solution forms, including 25% solutions.
Capabilities & Market Position:
Merck’s manufacturing processes focus on purity and process safety, meeting stringent quality standards. Their extensive distribution network supports the continuous supply of Mannitol with flexible packaging options.
Regulatory & Quality Assurance:
Euriso-top products adhere to pharmacopeial standards (USP, EP, JP), with regulatory approvals in the US, Europe, and emerging markets.
3. Roha Group / Avra Laboratories
Overview:
Indian-based Roha Group, in collaboration with Avra Laboratories, supplies Mannitol, emphasizing affordability without compromising quality. They offer pharmaceutical-grade Mannitol solutions, including 25% formulations, targeting developing markets.
Capabilities & Market Position:
With a focus on cost-effective manufacturing, the company supplies Mannitol across Asia, Africa, and parts of Latin America, with the ability to customize formulations according to customer requirements.
Regulatory Status:
Their products are often compliant with local pharmacopeia and international standards, including cGMP certifications.
4. SPI Pharma
Overview:
SPI Pharma provides pharmaceutical excipients, including Mannitol solutions, with a focus on Asia-Pacific markets and North America.
Capabilities & Market Position:
Their manufacturing facilities emphasize quality, safety, and innovation, supporting the production of sterile solutions suitable for infusion.
5. Other Notable Suppliers
- Applications in Pharma: Thermo Fisher Scientific, Sigma-Aldrich (a part of Merck), and FMC Biopolymer also produce pharmaceutical-grade Mannitol, but primarily as bulk powder rather than solutions.
- Emerging Suppliers: Several Chinese and Southeast Asian manufacturers are increasingly entering the market, offering competitive pricing but varying in regulatory compliance and quality assurance.
Market Dynamics and Supply Chain Considerations
Factors Influencing Supply
- Production Complexity: Manufacturing Mannitol 25% involves precise control of sterilization, purification, and formulation processes. Only specialized facilities can consistently produce high-purity solutions.
- Regulatory Compliance: Suppliers must meet stringent standards such as USP, EP, and FDA requirements, limiting the pool of reliable manufacturers.
- Raw Material Availability: The availability of raw materials like mannose or starch derivatives influences manufacturing capacity and costs.
- Global Demand Fluctuations: The COVID-19 pandemic underscored dependence on stable supply chains for critical pharmaceuticals, prompting increased scrutiny of supplier reliability.
- Pricing & Contracting: Competitive pricing strategies depend on scale, production efficiency, and regional market conditions. Long-term procurement agreements can secure priority access.
Risks and Mitigations
- Supply Disruptions: Dependency on limited suppliers poses risks. Establishing multiple sourcing arrangements mitigates this concern.
- Regulatory Changes: Variations in regulations across regions can impact approval and importation. Continuous compliance monitoring is essential.
- Quality Variability: Certifying suppliers against international standards reduces quality-related risks.
Regulatory and Quality Standards
Suppliers must adhere to several regulatory frameworks, including:
- United States Pharmacopeia (USP): Ensures pharmaceutical purity and consistency.
- European Pharmacopoeia (EP): Sets standards for European market compliance.
- Japanese Pharmacopoeia (JP): Relevant for Asian markets.
- FDA Approvals: Critical for suppliers serving US-based healthcare providers.
Manufacturers also maintain GMP certifications, ISO standards, and undergo regular audits to ensure product integrity and safety.
Strategic Sourcing Considerations
- Regional Diversification: Sourcing from multiple regions reduces geopolitical risks.
- Supplier Certifications: Preference for suppliers with recognized GMP, ISO, and pharmacopoeial certifications.
- Pricing & Lead Times: Negotiating flexible contracts with multiple suppliers can optimize costs and ensure timely delivery.
- Quality Assurance: Implementing rigorous testing standards upon receipt maintains supply chain integrity.
Conclusion
The supply of Mannitol 25% hinges on a select cadre of high-quality, regulatory-compliant manufacturers. Roquette and Merck emerge as industry leaders, with established global footprints, superior quality standards, and reliable regulatory approval. Suppliers like Roha Labs expand viability in emerging markets, offering cost-effective options. Understanding market dynamics, diversifying sourcing, and maintaining stringent quality checks are pivotal for stakeholders seeking a resilient supply chain for Mannitol 25%.
Key Takeaways
- Leading Suppliers: Roquette and Merck KGaA are the premier global providers of pharmaceutical-grade Mannitol 25%, offering reliable quality and regulatory compliance.
- Supply Chain Risks: Concentration of supply can cause disruptions; diversification and strategic procurement mitigate this risk.
- Regulatory Standards: Certifications like USP, EP, and GMP are non-negotiable for procurement, especially for international markets.
- Market Dynamics: Price fluctuations and raw material availability influence supply stability. Long-term contracts with diversified suppliers are advisable.
- Emerging Markets: Indian and Asian suppliers are increasingly pivotal, offering competitive pricing but require rigorous qualification processes.
FAQs
1. Who are the top global manufacturers of Mannitol 25% for pharmaceuticals?
Roquette and Merck KGaA are the foremost global manufacturers, providing high-purity, GMP-compliant Mannitol solutions suitable for intravenous use.
2. What are the primary factors to consider when sourcing Mannitol 25%?
Regulatory compliance, product quality, manufacturing capacity, supply chain reliability, and cost are critical factors.
3. How does the regulatory landscape impact Mannitol supply?
Regulatory standards like USP and EP ensure product quality and safety, affecting supplier selection and approval processes in different regions.
4. Are there regional suppliers that serve emerging markets?
Yes, Indian and Southeast Asian suppliers such as Roha Group and Avra Laboratories offer affordable options, though due diligence on quality and regulatory compliance is essential.
5. What risks should companies be aware of when sourcing Mannitol 25%?
Potential risks include supply disruptions, quality variability, regulatory hurdles, and raw material shortages; strategic planning and supplier diversification are key mitigation strategies.
Sources
[1] Roquette official website, Pharma-grade Mannitol overview.
[2] Merck KGaA Euriso-top, Pharmaceutical excipients catalog.
[3] Industry reports on pharmaceutical excipient suppliers.
[4] US Pharmacopeia (USP) standards documentation.
[5] WHO, "Guidelines on quality assurance of pharmaceuticals," 2022.
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