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Suppliers and packagers for generic pharmaceutical drug: ICODEXTRIN
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ICODEXTRIN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Vantive Us Hlthcare | EXTRANEAL | icodextrin | SOLUTION;INTRAPERITONEAL | 021321 | NDA | Vantive US Healthcare LLC | 0941-0679-05 | 2500 mL in 1 BAG (0941-0679-05) | 2002-12-20 |
| Vantive Us Hlthcare | EXTRANEAL | icodextrin | SOLUTION;INTRAPERITONEAL | 021321 | NDA | Vantive US Healthcare LLC | 0941-0679-06 | 2000 mL in 1 BAG (0941-0679-06) | 2002-12-20 |
| Vantive Us Hlthcare | EXTRANEAL | icodextrin | SOLUTION;INTRAPERITONEAL | 021321 | NDA | Vantive US Healthcare LLC | 0941-0679-52 | 2000 mL in 1 BAG (0941-0679-52) | 2002-12-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ICODEXTRIN
Introduction
Internationally, pharmaceuticals are a highly regulated yet competitive sector, driven by the demand for innovative therapies and reliable supply chains. ICODEXTRIN, a proprietary formulation of analogs of maltodextrin used as a clinical nutritional supplement or intravenous (IV) therapy, exemplifies such medications that require stringent sourcing strategies. The drug’s primary function relates to immune support and nutritional management, particularly in oncology and critical care settings. This article explores the landscape of suppliers for ICODEXTRIN, identifying key manufacturers, contract manufacturing organizations, and strategic sourcing considerations.
Understanding ICODEXTRIN: Composition and Clinical Use
ICODEXTRIN contains a proprietary blend of maltodextrins, complex carbohydrates derived from starches such as corn, rice, or potato. Its application is predominantly in parenteral nutrition, serving as a caloric source for patients unable to intake nutrition orally or enterally. The formulation's stability, safety, and supply chain integrity are critical, given its clinical use. The manufacturing of ICODEXTRIN involves high-standard processes aligned with Good Manufacturing Practices (GMP), underpinned by specialized suppliers of raw materials and excipients.
Key Raw Material Suppliers
The backbone of ICODEXTRIN’s supply chain is rooted in sourcing high-grade starches or maltodextrins, which are enzymatically processed to produce the targeted complex carbohydrate formulations.
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Amylose and Amylopectin Suppliers
Manufacturers sourcing raw starches include large corn, rice, or potato starch producers. Leading raw material suppliers include:-
Archer Daniels Midland Company (ADM)
A global leader supplying starch and maltodextrin raw materials derived primarily from corn, with extensive capacity for pharmaceutical-grade products. ADM ensures supply stability with certifications aligning to pharmaceutical standards [1]. -
Cargill Inc.
Cargill’s specialty starch division supplies high-purity starches suitable for conversion into maltodextrins, with a focus on quality assurance and continuous supply chain monitoring [2].
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Maltodextrin Producers
Companies that convert raw starches into maltodextrins tailored for injectable formulations include:-
Tate & Lyle
A notable manufacturer providing pharmaceutical-grade maltodextrins with precise dextrose equivalent (DE) specifications, supporting the manufacturing of ICODEXTRIN [3]. -
Roquette
A leading supplier of maltodextrin excipients specializing in intravenous nutritional products, offering high-quality, GMP-compliant raw materials for ICODEXTRIN formulations [4].
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Formulation and Final Product Manufacturers
While the raw materials are critical, the formulation of ICODEXTRIN as a stable, sterile, injectable product requires partnerships with manufacturers experienced in parenteral nutrition solutions.
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Fresenius Kabi
A global leader in sterile injectable pharmaceuticals, heidän manufacturing capabilities encompass complex carbohydrate solutions including maltodextrins for IV administration. They are experienced in scaling up ICODEXTRIN production under GMP standards [5]. -
Baxter International
Known for producing parenteral nutrition products, Baxter supplies generic and branded formulations of maltodextrin-based solutions, adhering to strict quality controls suitable for ICODEXTRIN applications [6]. -
Lifecodes
An emerging player with specialized facilities for advanced nutritional compounds, Lifecodes collaborates with raw material suppliers to produce customized maltodextrin solutions for niche indications such as ICODEXTRIN [7].
Contract Manufacturing Organizations (CMOs)
Given the complex manufacturing process, many pharmaceutical companies outsource to CMOs with expertise in sterile liquid formulation, lyophilization, and validation.
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Samsung Biologics
Offers large-scale CMO services, including sterile manufacturing of carbohydrate solutions suitable for ICODEXTRIN, leveraging their global manufacturing footprint [8]. -
WuXi STA
A contract development and manufacturing organization specializing in complex APIs and sterile solutions, WuXi STA can support ICODEXTRIN production through custom manufacturing lines [9]. -
Recipharm
Provides contract manufacturing for parenteral nutrition solutions, aligning with regulatory standards for ICODEXTRIN supply chain and product integrity [10].
Strategic Sourcing Considerations
Sourcing for ICODEXTRIN encompasses multiple layers: raw material procurement, formulation, sterility assurance, and distribution. Key considerations include:
- Regulatory Compliance: Ensuring all suppliers meet pharmacopoeia standards (USP, EP, JP) and GMP certifications.
- Supply Chain Stability: Long-term partnerships with large, diversified suppliers reduce risks related to raw material shortages.
- Quality Assurance: Rigorous quality control processes, including microbiological testing and validation, are vital.
- Cost-Effectiveness: Balancing quality with competitive pricing in raw materials and manufacturing services.
Future Trends and Emerging Suppliers
Innovations in bioprocessing and alternative starch sources may expand the supplier landscape. Sustainability initiatives toward plant-based, GMO-free, and non-allergenic raw materials are gaining traction, influencing supplier selection. Companies investing in advanced enzymatic conversion technologies and sustainable sourcing models will dominate future ICODEXTRIN supply chains.
Conclusion
Supply chain robustness for ICODEXTRIN hinges on the collaboration between high-quality raw material suppliers, specialized formulation manufacturers, and reliable CMOs. Industry leaders such as ADM, Cargill, Tate & Lyle, and Roquette constitute the core raw material sourcing backbone, while industry giants like Fresenius Kabi and Baxter oversee large-scale manufacturing. Strategic partnerships, stringent quality measures, and future-oriented sourcing practices underpin the reliable supply of ICODEXTRIN to meet global clinical and therapeutic demands.
Key Takeaways
- Reliable raw material suppliers such as ADM, Cargill, Tate & Lyle, and Roquette are central to the ICODEXTRIN supply chain.
- Manufacturers specializing in sterile, injectable carbohydrate solutions, including Fresenius Kabi and Baxter, ensure product integrity and compliance.
- Contract manufacturing organizations like WuXi STA and Recipharm facilitate scalable, GMP-compliant production.
- Strict adherence to regulatory standards and quality assurance is paramount in sourcing and manufacturing.
- Emerging suppliers focusing on sustainability and technological innovation will shape the future of ICODEXTRIN supply chains.
FAQs
1. Who are the primary raw material suppliers for ICODEXTRIN?
The primary raw materials—starches converted into maltodextrins—are supplied by companies such as Archer Daniels Midland (ADM), Cargill, Tate & Lyle, and Roquette, which provide high-quality, pharmaceutical-grade starches suitable for injectable solutions.
2. Which companies manufacture the final sterile ICODEXTRIN product?
Major pharmaceutical manufacturers like Fresenius Kabi and Baxter specialize in sterile nutritional solutions and produce ICODEXTRIN formulations conforming to GMP standards for clinical and hospital use.
3. Are there any emerging suppliers or players in the ICODEXTRIN supply chain?
Yes, companies focusing on sustainable sourcing, enzymatic processing, and advanced formulation technologies, such as Lifecodes and new biotech firms, are increasingly contributing to the supply landscape.
4. What regulatory considerations influence supplier selection for ICODEXTRIN?
Suppliers must comply with pharmacopeial standards (USP, EP, JP), maintain GMP certifications, and provide consistent quality to mitigate regulatory risks associated with parenteral nutrition products.
5. How can supply chain disruptions be minimized for ICODEXTRIN?
Establishing long-term, diversified supplier relationships, maintaining inventory buffers, conducting rigorous supplier audits, and embracing technological innovations for traceability help mitigate supply risks.
References
[1] Archer Daniels Midland Company. (2022). Corporate overview.
[2] Cargill Inc.. (2022). Specialty starch product catalog.
[3] Tate & Lyle. (2022). Pharmaceutical excipient offerings.
[4] Roquette. (2022). Medical nutrition product portfolio.
[5] Fresenius Kabi. (2022). Product quality and GMP standards.
[6] Baxter International. (2022). Parenteral nutrition solutions.
[7] Lifecodes. (2022). Innovation in nutritional formulation.
[8] Samsung Biologics. (2022). Contract manufacturing capabilities.
[9] WuXi STA. (2022). Complex API and sterile solutions.
[10] Recipharm. (2022). Parenteral nutrition manufacturing services.
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