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Suppliers and packagers for generic pharmaceutical drug: dextrose; potassium chloride
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dextrose; potassium chloride
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 | DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% | dextrose; potassium chloride | INJECTABLE;INJECTION | 212346 | ANDA | Fresenius Kabi USA, LLC | 63323-667-10 | 10 BAG in 1 CASE (63323-667-10) / 1000 mL in 1 BAG (63323-667-01) | 2021-04-23 |
| Fresenius Kabi Usa | DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% | dextrose; potassium chloride | INJECTABLE;INJECTION | 212346 | ANDA | Fresenius Kabi USA, LLC | 63323-669-10 | 10 BAG in 1 CASE (63323-669-10) / 1000 mL in 1 BAG (63323-669-01) | 2021-04-23 |
| Baxter Hlthcare | DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER | dextrose; potassium chloride | INJECTABLE;INJECTION | 017634 | NDA | Baxter Healthcare Company | 0338-0683-04 | 1000 mL in 1 BAG (0338-0683-04) | 1979-02-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drugs: Dextrose and Potassium Chloride
Introduction
Dextrose and potassium chloride are critical pharmaceutical ingredients with widespread medical applications. Dextrose, a form of glucose, serves as an energy source in intravenous therapies, while potassium chloride is essential for correcting electrolyte imbalances. The global supply chains for these substances involve a complex network of manufacturers, chemical producers, and distributors. Understanding the key suppliers in this market is vital for pharmaceutical companies, healthcare providers, and investors seeking supply stability, cost efficiency, and regulatory compliance.
Market Overview of Dextrose and Potassium Chloride
The demand for dextrose and potassium chloride is driven by diverse sectors, including hospitals, clinical laboratories, and pharmaceutical manufacturing. The global dextrose market was valued at approximately USD 2.8 billion in 2022, with an expected compound annual growth rate (CAGR) of around 4.5% through 2030 [1]. Similarly, potassium chloride, a vital mineral supplement, is produced in large volumes for both pharmaceutical and agricultural applications, with the pharmaceutical grade market expanding in tandem with healthcare needs.
The supply chain for these chemicals hinges on manufacturing scale, raw material availability, regulatory standards, and geopolitical stability. Key producing regions include North America, Europe, and Asia, with major players seeking compliance with Good Manufacturing Practices (GMP) and other regulatory protocols.
Leading Suppliers of Dextrose
1. Archer Daniels Midland Company (ADM)
ADM is a dominant supplier of dextrose globally, producing high-quality glucose monohydrate primarily derived from corn starch. With extensive manufacturing assets across North America, Europe, and Asia, ADM ensures reliable supply and compliance with international standards [2].
2. Cargill, Inc.
Another major global player, Cargill supplies dextrose monohydrate to pharmaceutical and food industries. Their product portfolio emphasizes purity and pharmaceutical-grade standards, backed by rigorous quality assurances and extensive global logistics networks [3].
3. Roquette Frères
A leading French manufacturer specializing in specialty starches and derivatives, Roquette produces pharmaceutical-grade dextrose. Their focus on innovation and adherence to GMP standards grants them a competitive edge in supplying high-purity glucose for injectable or oral applications [4].
4. Ingredion Incorporated
Ingredion offers dextrose monohydrate with certifications suitable for pharmaceutical use. Their manufacturing facilities in North America, South America, and Asia support a broad geographic reach and consistent supply [5].
Leading Suppliers of Potassium Chloride
1. AkzoNobel (formerly part of Orica)
As a key producer, AkzoNobel supplies pharmaceutical-grade potassium chloride, primarily sourced from regional mining and salt production facilities. Their adherence to strict GMP standards and global distribution channels make them a primary supplier [6].
2. Nunthorpe Holdings Ltd.
Based in the UK, Nunthorpe Holdings is a significant specialty chemical supplier of potassium chloride for pharmaceutical applications. They emphasize quality control, compliance with pharmacopeias, and reliable global supply chains [7].
3. The Potash Corporation of Saskatchewan ( Nutrien Ltd. )
Nutrien is one of the world's largest potash producers, offering potassium chloride that meets pharmaceutical standards. Their extensive mining capacity and distribution infrastructure ensure consistent supply for pharmaceutical needs [8].
4. Olin Corporation
Olin supplies pharmaceutical-grade potassium chloride, leveraging its chlor-alkali production facilities to ensure product purity and consistency. Their global logistics and compliance with regulatory standards position them as a key player [9].
Regional Suppliers and Emerging Markets
Beyond the leading multinationals, regional suppliers in China, India, and Eastern Europe are gaining prominence. Notably:
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China’s Chengdu Chemical & Pharmaceutical Industries Group produces bulk pharmaceutical-grade dextrose and potassium chloride, and exports globally under GMP compliance.
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India’s Gujarat State Fertilizers & Chemicals Limited (GSFC) manufactures potassium chloride for pharmaceutical use, with increasing export capacity.
These emerging suppliers often offer cost advantages and are integrating into global supply chains, though quality assurance and regulatory compliance remain priorities.
Regulatory Considerations and Quality Standards
Suppliers must meet regulatory requirements such as USP (United States Pharmacopeia), EP (European Pharmacopoeia), and JP (Japanese Pharmacopoeia). Compliance ensures pharmaceutical safety, efficacy, and international market access. Major suppliers invest heavily in GMP-certified manufacturing, rigorous quality testing, and traceability measures.
Supply Chain Dynamics
The supply of dextrose and potassium chloride hinges on raw material availability (e.g., corn starch, salt, potash), manufacturing capacity, and geopolitical stability. Recent disruptions, including global logistics challenges and raw material shortages, influence supplier reliability. Strategic sourcing and diversification are key to mitigating risks.
Sustainability and Future Outlook
Sustainable sourcing practices are increasingly important. Suppliers are adopting greener extraction and manufacturing methods, reducing carbon footprints, and ensuring ethical sourcing. The demand for pharmaceutical-grade dextrose and potassium chloride is projected to grow, emphasizing the need for resilient, compliant supply chains.
Key Takeaways
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Major global suppliers of pharmaceutical-grade dextrose include ADM, Cargill, Roquette, and Ingredion, with established GMP compliance and extensive distribution networks.
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Leading suppliers of potassium chloride encompass AkzoNobel, Nutrien, Olin, and Nunthorpe Holdings, offering high-purity products aligned with international standards.
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Regional emerging suppliers in China and India present cost-effective options but require thorough quality and regulatory vetting.
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Supply chain resilience depends on raw material access, regulatory compliance, and geopolitical stability. Diversification remains critical.
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Sustainability initiatives are influencing supplier strategies, aligning with global environmental, social, and governance (ESG) standards.
FAQs
Q1: What factors should pharmaceutical companies consider when selecting a supplier for dextrose and potassium chloride?
A1: Companies should evaluate product purity, GMP and other regulatory certifications, supply stability, lead times, cost, and sustainability practices. Ensuring traceability and compliance with pharmacopeias is critical.
Q2: How do regional geopolitical issues impact the supply of these chemicals?
A2: Political instability, trade restrictions, and tariffs can disrupt supply, increase costs, or delay shipments. Diversifying suppliers across regions mitigates these risks.
Q3: Are there any emerging suppliers offering competitive advantages?
A3: Yes, suppliers in China and India are expanding capacity, offering cost-effective products. However, stringent quality assurance and regulatory compliance are vital for safe pharmaceutical applications.
Q4: What are the key regulatory standards these suppliers must meet?
A4: Suppliers need to meet standards such as USP, EP, JP, and comply with Good Manufacturing Practices (GMP) to ensure pharmaceutical-grade quality.
Q5: What sustainability trends are influencing supplier choices?
A5: Increasing emphasis on environmentally friendly manufacturing, reduced carbon emissions, and ethical sourcing influence procurement decisions. Suppliers adopting green practices may offer competitive advantages.
References
- [MarketWatch, "Global Dextrose Market Size & Forecast," 2022]
- [ADM Corporate Website, Product Portfolio]
- [Cargill Annual Report, 2022]
- [Roquette Official Website, Product Standards]
- [Ingredion Incorporated, Sustainability Report 2022]
- [AkzoNobel, Specialty Chemicals Division]
- [Nunthorpe Holdings, Product Certification Details]
- [Nutrien Ltd., Market Office Data]
- [Olin Corporation, Chemical Manufacturing Overview]
In conclusion, securing reliable supplies of pharmaceutical-grade dextrose and potassium chloride requires comprehensive understanding of the leading suppliers, regional influences, regulatory standards, and evolving market dynamics. Strategic sourcing, adherence to quality standards, and sustainability commitments are paramount to maintaining an efficient and compliant supply chain in the pharmaceutical sector.
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