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Suppliers and packagers for SORBITOL-MANNITOL IN PLASTIC CONTAINER
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SORBITOL-MANNITOL IN PLASTIC CONTAINER
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 |
ppliers for the Pharmaceutical Drug: Sorbitol-Mannitol in Plastic Container
Introduction
The pharmaceutical industry demands high-quality, reliable suppliers for excipients like sorbitol and mannitol, especially when packaged in plastic containers for oral and topical applications. These sugar alcohols serve as fillers, sweeteners, and stabilizers, making their purity and supply chain integrity crucial. This article evaluates key suppliers specializing in sorbitol and mannitol in plastic containers, emphasizing their global presence, quality standards, and supply capabilities.
Understanding Sorbitol and Mannitol in Pharmaceutical Context
Sorbitol is a sugar alcohol widely used as a sweetener, humectant, and excipient in tablets, syrups, and topical formulations. Mannitol is another sugar alcohol primarily used as an osmotic diuretic, excipient, and stabilizer. Both compounds must comply with pharmacopoeia standards (e.g., USP, EP) for pharmaceutical applications, underscoring the need for certified suppliers with documented quality assurance.
Packaging in plastic containers offers benefits of convenience, product stability, and ease of handling—particularly for powders and solutions. Suppliers must provide containers that are inert, contamination-free, and compatible with pharmaceutical standards.
Global Supplier Landscape
1. Roquette Frères (France)
Overview: Roquette is a leading global manufacturer of pharmaceutical excipients, including sorbitol and mannitol, with a robust portfolio of high-purity products. Their products are manufactured under strict GMP compliance and supplied in various packaging formats, including plastic.
Capabilities:
- cGMP-certified manufacturing facilities
- Multiple packaging options, including plastic bottles and drums
- Extensive regional distribution, including North America, Europe, and Asia
Relevance:
Roquette’s PEG-OS sorbitol and Branched Mannitol meet USP, EP, and JP standards, suitable for pharmaceutical formulations requiring packaged excipients in plastic containers.
2. SPI Pharma (United States)
Overview: SPI Pharma specializes in pharmaceutical-grade excipients, offering sorbitol and mannitol with high purity and consistent quality.
Capabilities:
- GMP-certified facilities
- Custom packaging options, including HDPE and PET plastic bottles and containers
- Supply chain flexibility to accommodate small or large orders
Relevance:
SPI Pharma’s focus on pharmaceutical applications ensures products are compatible with stringent safety and quality requirements, making them reliable suppliers for plastic-packaged excipients.
3. Merck KGaA (Germany)
Overview: Merck supplies a wide range of pharmaceutical excipients, including sorbitol and mannitol, sourced from high-quality standards in European markets.
Capabilities:
- Extensive experience in production of pharmaceutical excipients
- Packaging solutions tailored to client needs, including plastic containers
- Products verified for compliance with global pharmacopeias
Relevance:
Merck’s Emprove platform ensures high-quality, traceable excipients compatible with plastic packaging formats.
4. Tereos (France)
Overview: Tereos produces sorbitol and other sugar alcohols primarily for pharmaceutical and food industries.
Capabilities:
- Global manufacturing presence
- Offering pharmaceutical-grade sorbitol in various packaging forms, including plastic bottles and drums
Relevance:
Their products meet pharmaceutical standards with proven supply reliability, especially suited for large-volume applications.
5. Ingredion Incorporated (United States)
Overview: Ingredion provides a wide array of excipients, including sorbitol and mannitol, emphasizing purity and safety.
Capabilities:
- GMP certification and rigorous quality control
- Packaging options include plastic containers for ease of distribution and usage
Relevance:
Their pharmaceutical-grade products are compatible with sterile and non-sterile applications requiring plastic packaging.
Key Factors in Selecting Suppliers
- Regulatory Compliance: Suppliers must adhere to USP, EP, or JP standards, confirming high purity and safety profiles.
- Packaging Capabilities: Confirm the availability of sturdy, inert plastic containers such as HDPE or PET bottles, suitable for pharmaceutical use.
- Supply Chain Reliability: Ensuring consistent raw material availability and distribution channels.
- Quality Certification: Look for GMP, ISO, and other relevant certifications.
- Custom Packaging: Ability to provide tailored packaging sizes and types based on formulation needs.
Emerging Trends & Considerations
- Sustainability: Preference for eco-friendly packaging options to align with environmental regulations and corporate responsibility.
- Supply Chain Resilience: Diversification of suppliers to mitigate risks associated with geopolitical shifts or raw material shortages.
- Regulatory Vigilance: Keeping abreast of regulation updates impacting excipient sourcing and packaging standards globally.
Conclusion
Establishing partnerships with reputable suppliers of sorbitol and mannitol packaged in plastic containers is crucial for pharmaceutical manufacturers seeking quality, reliability, and compliance. Companies like Roquette, SPI Pharma, Merck KGaA, Tereos, and Ingredion stand out as prominent suppliers capable of meeting stringent pharmaceutical standards while providing flexible packaging solutions. Strategic sourcing, anchored in regulatory compliance and supply chain resilience, ensures uninterrupted production flows and sustained product quality.
Key Takeaways
- Leading suppliers such as Roquette and Merck provide high-quality sorbitol and mannitol in plastic containers, adhering to global pharmacopeial standards.
- Packaging in plastic containers offers convenience and product stability, but supplier compliance with inert and contamination-free packaging is essential.
- Quality certifications, regulatory adherence, and supply chain robustness are critical selection criteria.
- Emerging trends favor sustainable packaging and diversified supplier networks to mitigate risks.
- Maintaining up-to-date knowledge of regulations and supplier capabilities is vital for successful procurement in pharmaceutical applications.
FAQs
1. Are all pharmaceutical-grade sorbitol and mannitol suitable for plastic packaging?
Yes. Reputable suppliers ensure their pharmaceutical-grade sorbitol and mannitol are compatible with plastic packaging, provided the containers meet inertness and safety standards necessary for pharmaceutical applications.
2. What are the primary regulatory standards for pharmaceutical excipients in plastic containers?
Common standards include USP (United States Pharmacopeia), EP (European Pharmacopoeia), and JP (Japanese Pharmacopoeia). Suppliers must provide certificates of analysis verifying compliance.
3. How do suppliers ensure the quality of sorbitol and mannitol in plastic containers?
Through rigorous GMP-certified manufacturing processes, comprehensive quality control testing, and traceability measures aligned with international standards.
4. Can custom packaging solutions be accommodated?
Yes. Most leading suppliers offer tailored packaging options, including various sizes, types of plastic containers, and labeling to meet specific client requirements.
5. What are the considerations for choosing between different suppliers?
Key factors include regulatory compliance, quality assurance, packaging options, supply chain reliability, cost, and ability to meet delivery schedules.
References
[1] Roquette Frères. "Pharmaceutical Excipients," Roquette Corporate Website, 2023.
[2] SPI Pharma. "High Purity Excipients," SPI Pharma Product Catalog, 2023.
[3] Merck KGaA. "Pharmaceutical Excipients Portfolio," Merck Global Pharmaceutical Solutions, 2023.
[4] Tereos. "Sorbitol and Mannitol Products," Tereos Corporate Publications, 2023.
[5] Ingredion Incorporated. "Pharmaceutical Excipients," Ingredion Official Website, 2023.
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