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Suppliers and packagers for generic pharmaceutical drug: DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE
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DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| B Braun | ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER | dextrose; magnesium chloride; potassium chloride; potassium phosphate, dibasic; sodium acetate | INJECTABLE;INJECTION | 019873 | NDA | B. Braun Medical Inc. | 0264-7730-10 | 24 CONTAINER in 1 CASE (0264-7730-10) / 500 mL in 1 CONTAINER | 1993-06-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drugs: Dextrose, Magnesium Chloride, Potassium Chloride, Potassium Phosphate, Dibasic, and Sodium Acetate
Introduction
The procurement landscape for essential pharmaceutical ingredients such as Dextrose, Magnesium Chloride, Potassium Chloride, Potassium Phosphate, Dibasic, and Sodium Acetate encompasses a diverse array of global suppliers. These compounds are vital in various medical applications, ranging from intravenous fluids to electrolyte management. Ensuring a reliable supply chain involves understanding the key manufacturers, geographic distribution, quality certifications, and market dynamics. This article provides an in-depth analysis of leading suppliers for these critical pharmaceuticals, offering insights for healthcare providers, pharmaceutical companies, and procurement professionals seeking dependable sourcing options.
Overview of the Pharmaceuticals
Dextrose (Glucose)
A sugar used extensively in intravenous therapy, nutrition formulations, and as a carbohydrate source, Dextrose is produced through the hydrolysis of starches, primarily corn or wheat-based. The pharmaceutical-grade Dextrose must meet stringent purity standards such as USP, EP, or JP specifications.
Magnesium Chloride
Often used in electrolyte therapy, magnesium chloride is critical for managing hypomagnesemia and as a component in dialysis solutions. It exists as an anhydrous or hexahydrate form and requires high purity for pharmaceutical purposes.
Potassium Chloride
Commonly administered intravenously to correct hypokalemia, potassium chloride demands high-quality standards to prevent contaminations and ensure patient safety.
Potassium Phosphate, Dibasic
This compound functions in parenteral nutrition and electrolyte restoration, necessitating tight control of pH and purity levels during manufacturing.
Sodium Acetate
Used in dialysis, IV fluids, and pH regulation, sodium acetate’s supply chain involves strict compliance with pharmacopeial standards for safety and efficacy.
Global Market Overview and Key Suppliers
The supply chain for these pharmaceuticals is governed by leading chemical and pharmaceutical manufacturers, with key sourcing regions including North America, Europe, and Asia. The following sections detail prominent suppliers for each compound based on market share, quality standards, and reliability.
Suppliers for Dextrose
1. Roquette Frères (France)
A major player in the production of pharmaceutical-grade Dextrose, Roquette supplies globally with manufacturing facilities in France, the United States, and China. Their products conform to USP and EP standards, with a reputation for consistency and quality.
2. Archer Daniels Midland Company (USA)
ADM produces high-quality Dextrose from corn sources, adhering to Good Manufacturing Practices (GMP). Their extensive distribution network supports global supply requirements.
3. Ingredion Incorporated (USA)
Ingredion supplies pharmaceutical-grade Dextrose derived from maize, boasting multiple certifications including ISO 9001 and cGMP compliance.
4. CJ CheilJedang (South Korea)
A significant Asian supplier, CJ’s Dextrose products meet international standards, with sourcing that benefits from Korea’s robust manufacturing infrastructure.
Suppliers for Magnesium Chloride
1. Haifa Chemicals (Israel)
Specializing in mineral salts, Haifa produces pharmaceutical-grade magnesium chloride hexahydrate, with global distribution and adherence to pharmacopeial specifications.
2. Maruo Calcium Industrial Co., Ltd. (Japan)
Known for high-purity magnesium salts, their products are used extensively in medical and industrial applications.
3. Jordan Phosphate Mines Company (Jordan)
A key regional supplier, Jordan Phosphate Mines manufactures magnesium chloride as a byproduct from phosphate ore processing, ensuring competitive pricing for large-volume buyers.
4. Fosfa A/S (Denmark)
Purveyor of specialty salts, Fosfa supplies pharmaceutical-grade magnesium chloride with certifications supporting medical applications.
Suppliers for Potassium Chloride
1. AkzoNobel (The Netherlands)
Operating through its chemical division, AkzoNobel produces high-purity potassium chloride used in pharmaceutical applications, with rigorous quality standards.
2. Orocobre Limited (Australia)
This lithium and potassium producer offers potassium chloride suitable for IV formulations, with attention to purity and contaminant control.
3. Potash Corporation of Saskatchewan (Canada)
Now Nutrien Ltd., it supplies potassium chloride with established pharmaceutical-grade quality standards.
4. Intrepid Potash (USA)
A leading North American supplier, serving the pharmaceutical segment with high-purity potassium chloride products.
Suppliers for Potassium Phosphate, Dibasic
1. Corrado Phosphate (Italy)
A specialized producer offering pharmaceutical-grade potassium phosphate dibasic, meeting USP and EP standards for injections and nutritional products.
2. Showa Pharmaceutical Industries (Japan)
Provides high-quality potassium phosphate solutions with global distribution capabilities aligned with pharmacopeial requirements.
3. STERIS Corporation (USA)
Offers bulk potassium phosphate, adhering to the strict purity and quality controls necessary for parenteral use.
4. Jiande Jinchang Chemical Co., Ltd. (China)
A regional supplier expanding globally, compliant with international standards for pharmaceutical-grade potassium phosphate.
Suppliers for Sodium Acetate
1. Anhui Huahong Pharmaceutical Co., Ltd. (China)
A leading manufacturer of pharmaceutical-grade sodium acetate, with extensive certifications for global markets.
2. Thermo Fisher Scientific (USA)
Supplies high-purity sodium acetate salt, primarily for research but also for pharmaceutical formulations.
3. Merck KGaA (Germany)
Provides pharmaceutical-grade sodium acetate with strict adherence to European standards and global certifications.
4. CIDEX (India)
Offers sodium acetate trihydrate suitable for medical use, with a focus on affordability without compromising quality.
Quality Certifications and Regulatory Compliance
Reliable suppliers adhere to regulatory standards such as the USP, EP, JP, and ISO certifications, along with Good Manufacturing Practice (GMP) compliance. Suppliers with strong quality control protocols mitigate risks associated with contamination, impurities, and inconsistent product performance, which is critical for pharmaceuticals.
Market Dynamics and Procurement Strategies
The global supply landscape is influenced by raw material availability, manufacturing capacity, geopolitical stability, and regulatory changes. Market consolidation is evident among large pharmaceutical ingredient producers, increasing bargaining power and influencing pricing trends.
Businesses should prioritize establishing relationships with suppliers holding recognized certifications and proven track records of quality consistency. Long-term contracts and diversified sourcing strategies mitigate risks related to supply disruptions, especially as geopolitical tensions and pandemic impacts continue to influence supply chains.
Conclusion
Sourcing pharmaceutical-grade Dextrose, Magnesium Chloride, Potassium Chloride, Potassium Phosphate, Dibasic, and Sodium Acetate requires careful vendor selection grounded in quality, regulatory compliance, and supply reliability. Leading global suppliers such as Roquette, ADM, Haifa Chemicals, and AkzoNobel offer dependable options backed by stringent certifications. Strategic procurement involves fostering supplier relationships, monitoring regulatory changes, and ensuring supply chain resilience to meet the evolving needs of healthcare providers and pharmaceutical firms.
Key Takeaways
- Global suppliers of these pharmaceuticals include prominent manufacturers from North America, Europe, and Asia, each with specific strengths in geographic reach and product quality.
- Consistent regulatory compliance and certifications (USP, EP, GMP) are non-negotiable indicators of supplier reliability.
- The ongoing consolidation among suppliers amplifies the importance of diversified sourcing strategies to reduce procurement risks.
- Raw material availability and geopolitical factors can impact supply stability; proactive planning is vital.
- Building partnerships with verified, certified suppliers enhances supply chain security and product quality assurance.
FAQs
1. What are the primary considerations when selecting suppliers for pharmaceutical-grade Dextrose and electrolytes?
Quality certifications (USP, EP, GMP), product purity, manufacturing capacity, compliance history, and logistical capabilities.
2. How do regional regulations influence supplier choice?
Regulatory frameworks vary across countries; suppliers must meet local and international standards to ensure product acceptance in target markets.
3. Can alternative sourcing regions provide comparable quality?
Yes, regions such as Asia and the Middle East have emerging manufacturers adhering to global standards, but due diligence on certifications and quality controls is essential.
4. What role do certifications like ISO 9001 and GMP play in supplier evaluation?
They demonstrate commitment to quality management systems and manufacturing practices, reducing risks of contamination and inconsistencies.
5. How should companies approach supply chain resilience for these pharmaceuticals?
Develop diversified supplier networks, establish long-term contracts, monitor geopolitical developments, and maintain safety stock levels to mitigate disruptions.
Sources
- [Pharmaceutical Ingredients Suppliers Directory], Pharmaceutical Technology, 2022.
- [Global Market for Injectables and Electrolytes], IMS Health Report, 2021.
- [Regulatory Standards for Pharmaceutical Compounds], U.S. Pharmacopeia, 2022.
- [Major Suppliers’ Certifications and Quality Standards], Company Reports, 2022.
- [Global Raw Material Supply Chain Trends], World Health Organization, 2022.
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