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Suppliers and packagers for generic pharmaceutical drug: MANNITOL; SORBITOL
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MANNITOL; SORBITOL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Otsuka Icu Medcl | SORBITOL-MANNITOL IN PLASTIC CONTAINER | mannitol; sorbitol | SOLUTION;IRRIGATION | 018316 | NDA | ICU Medical Inc. | 0990-7981-08 | 4 POUCH in 1 CASE (0990-7981-08) / 1 BAG in 1 POUCH / 3000 mL in 1 BAG | 2019-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Pharmaceutical Drugs Mannitol and Sorbitol
Introduction
The global pharmaceutical industry relies heavily on reliable suppliers of excipients such as mannitol and sorbitol, which are critical for various medicinal and formulation applications. Mannitol, a sugar alcohol used as a cryoprotectant and diuretic, and sorbitol, also a sugar alcohol, serve as excipients, fillers, and sweeteners in drug formulations, particularly in chewable tablets, syrups, and injectable products. Their commercial importance continues to grow, emphasizing the need to identify and assess key suppliers that meet quality, regulatory, and supply chain requirements.
Market Overview
The demand for mannitol and sorbitol reflects their extensive use in pharmaceuticals, cosmetics, food, and medical devices. The Pharmaceutical excipients market was valued at USD 6.09 billion in 2021, with sugar alcohols constituting a significant sub-segment due to their functional benefits and safety profile. The industry demands high purity, consistent quality, and compliance with standards such as USP, EP, JP, and FDA regulations.
Leading Mannitol Suppliers
1. Roquette Frères
Overview: A top global supplier, Roquette specializes in plant-based pharmaceutical excipients, including Mannitol (Pearlitol®). Their manufacturing facilities in France and the USA produce pharmaceutical-grade mannitol compliant with international pharmacopeias.
Strengths:
- Extensive R&D capabilities.
- Proven regulatory track record.
- Robust global distribution network.
- Product purity levels ≥99.5%.
Applications: Used as a bulking agent, diuretic, and excipient in tablets, capsules, and injectable formulations.
2. SPI Pharma (Part of Symrise AG)
Overview: SPI Pharma supplies pharmaceutical-grade mannitol focused on compression and freeze-dried applications, with manufacturing in the USA and Europe.
Strengths:
- Expertise in formulation support.
- ISO-certified facilities.
- Diversified portfolio including spray-dried mannitol.
3. Merck KGaA (MilliporeSigma in North America)
Overview: Merck offers pharmaceutical-grade mannitol, including its grade for injectable and tablet use, adhering to strict quality standards.
Strengths:
- Global presence.
- Extensive regulatory compliance.
- Scientific support services.
4. Fisher Scientific (Thermo Fisher Scientific)
Overview:
Provides pharmaceutical-grade mannitol suitable for research, development, and manufacturing, ensuring high purity and quality control.
Key Sorbitol Suppliers
1. Roquette Frères
Overview:
As a leader in sorbitol production, Roquette supplies both pharmaceutical and food-grade sorbitol, with multiple manufacturing sites in Europe, the USA, and Asia.
Strengths:
- High-quality product range.
- Consistently compliant with pharmacopeial standards.
- Innovative formulations for sustained-release and mucoadhesive applications.
2. Cargill
Overview:
Cargill produces pharmaceutical-grade sorbitol used in confectionery, medical, and pharmaceutical sectors. Their production facilities include plants in the USA, Brazil, and Europe.
Strengths:
- Supply reliability.
- Extensive R&D for custom sorbitol grades.
- Strict quality assurance programs.
3. Archer Daniels Midland (ADM)
Overview:
ADM provides sorbitol with high purity, suitable for injectables, syrups, and topical formulations, with manufacturing facilities across North America and Europe.
Strengths:
- Global logistics capabilities.
- Proven compliance with GMP standards.
- Focus on sustainable practices.
4. Merck KGaA (MilliporeSigma)
Overview:
Supplies pharmaceutical-grade sorbitol, tailored for medicinal and research applications, ensuring high purity and stability.
Emerging and Regional Suppliers
Several regional players focus on niche markets or offer cost-effective solutions, including:
- DOW Chemicals (now part of Dow Inc.) – supplies sorbitol derivatives and high-purity products.
- JRS Pharma – specialized in pharmaceutical and nutraceutical excipients.
- Shandong Mingshui Sucrose – a Chinese manufacturer providing competitive sorbitol grades.
While these suppliers may not have the same global footprint as the industry leaders, they are increasingly vital in regions with growing pharmaceutical manufacturing capacities.
Regulatory and Quality Considerations
Suppliers must demonstrate compliance with pharmacopeial standards such as USP, EP, JP, or other regional standards, alongside Good Manufacturing Practices (GMP) certification. Product documentation should include Certificates of Analysis (CoA), stability data, and regulatory dossiers, especially for injectable and parenteral applications.
Supply Chain and Risk Management
Disruptions in raw material sourcing, geopolitical issues, or logistical challenges can impact the supply of mannitol and sorbitol. Leading suppliers mitigate these risks through diversified manufacturing locations, strategic inventory management, and quality assurance protocols. The ongoing demand surge emphasizes the importance of reliable, long-term supplier relationships.
Conclusion
The pharmaceutical sector's dependence on high-quality mannitol and sorbitol necessitates sourcing from established, compliant suppliers. Roquette Frères emerges as a prominent global leader, offering extensive product ranges with tailored specifications. Merck, Cargill, and Archer Daniels Midland stand as robust alternatives, prioritizing quality, consistency, and supply security. Regional suppliers can address localized needs but should align with global regulatory standards for integrated supply chain resilience.
Key Takeaways
- Global leaders such as Roquette and Merck dominate the supply of pharmaceutical-grade mannitol and sorbitol, backed by extensive R&D, quality control, and regulatory compliance.
- Quality certification (GMP, ISO, pharmacopeial compliance) remains non-negotiable for pharmaceutical applications.
- Supply chain complexity mandates sourcing diversification, especially during unprecedented market disruptions.
- Emerging regional suppliers can offer cost-effective solutions but require thorough vetting for compliance and quality.
- Strategic partnerships facilitate supply stability and support formulation innovation.
FAQs
1. How do I select a reliable supplier for pharmaceutical-grade mannitol or sorbitol?
Assess their compliance with GMP and pharmacopeial standards, review their quality assurance processes, verify their regulatory track record, and evaluate supply chain stability and certifications.
2. Are all sorbitol and mannitol products suitable for injectable formulations?
No. Only products manufactured under strict GMP conditions, with high purity levels and documented compliance, are suitable for injectable applications.
3. What are the environmental and sustainability considerations for suppliers?
Leading suppliers adopt sustainable practices, including responsible sourcing, waste reduction, and energy-efficient manufacturing, aligning with global sustainability standards.
4. How does regional regulation influence supplier choice?
Suppliers must meet regional regulatory requirements; for instance, approvals from FDA (USA), EMA (Europe), or PMDA (Japan) are critical for market access.
5. Can regional suppliers match global suppliers in quality and compliance?
While some regional suppliers are improving standards, global leaders generally have more extensive compliance frameworks. Due diligence is essential to ensure they meet or exceed regulatory standards.
Sources:
- MarketWatch. "Pharmaceutical Excipients Market Size & Share."
- Roquette official website. Product and regulatory information.
- MilliporeSigma (Merck KGaA). Product specifications.
- Cargill official website. Product portfolio and certifications.
- ADM official communications. Supply chain and quality assurance.
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