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Suppliers and packagers for POTASSIUM CHLORIDE 40MEQ
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POTASSIUM CHLORIDE 40MEQ
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 | POTASSIUM CHLORIDE 40MEQ | potassium chloride | INJECTABLE;INJECTION | 211087 | ANDA | Fresenius Kabi USA, LLC | 65219-004-01 | 60 BAG in 1 CARTON (65219-004-01) / 50 mL in 1 BAG (65219-004-00) | 2021-06-25 |
| Fresenius Kabi Usa | POTASSIUM CHLORIDE 40MEQ | potassium chloride | INJECTABLE;INJECTION | 211087 | ANDA | Fresenius Kabi USA, LLC | 65219-006-01 | 50 BAG in 1 CARTON (65219-006-01) / 100 mL in 1 BAG (65219-006-00) | 2021-06-25 |
| Fresenius Kabi Usa | POTASSIUM CHLORIDE 40MEQ | potassium chloride | INJECTABLE;INJECTION | 211087 | ANDA | Fresenius Kabi USA, LLC | 65219-008-51 | 60 BAG in 1 CARTON (65219-008-51) / 50 mL in 1 BAG (65219-008-50) | 2021-06-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Potassium Chloride 40mEq
Introduction
Potassium chloride (KCl) is a vital electrolyte used in medical settings to treat or prevent potassium deficiency, which can result from various conditions including vomiting, diarrhea, or certain medications. The 40mEq dosage is commonly administered via IV infusion or oral formulations to restore and maintain electrolyte balance. The global market for this pharmaceutical compound involves numerous suppliers spanning major pharmaceutical manufacturers, active pharmaceutical ingredient (API) producers, and contract manufacturing organizations (CMOs). Understanding these suppliers’ landscape provides insight into sourcing strategies, supply chain stability, and regulatory compliance for healthcare providers and pharmaceutical companies.
Global Market Overview
The demand for potassium chloride as a pharmaceutical grade product has been driven by increasing prevalence of electrolyte disturbances, aging populations, and expansion of intravenous therapy across healthcare settings. As of 2023, the supply chain encompasses a mix of synthetic API manufacturers in India, China, Europe, and North America, along with specialized drug formulation firms. The sourcing landscape is characterized by high regulatory standards (US FDA, EMA, PMDA), quality assurance, and adherence to Good Manufacturing Practice (GMP).
Major Suppliers of Potassium Chloride 40mEq
1. API Manufacturers
a. Fosun Pharma (China)
Fosun Pharma is a leading global manufacturer supplying bulk potassium chloride API, with production capacities exceeding 50,000 metric tons annually. Their product complies with USP, EP, and JP standards, making them a preferred choice for pharmaceutical formulations. Their integrated production process ensures high purity levels suitable for injectable and oral forms [1].
b. Sinopharm Group (China)
Sinopharm operates multiple manufacturing plants producing potassium chloride API, claiming rigorous quality controls aligned with international certifications. They export to North America, Europe, and Asia, catering to large-volume pharmaceutical companies [2].
c. Indian API Producers (e.g., Madras Pharmaceuticals, Aarti Industries)
Indian firms like Madras Pharmaceuticals produce high-quality potassium chloride API, leveraging low-cost manufacturing while adhering to stringent regulatory standards. These companies primarily export to global markets, especially the US and Europe, under cGMP protocols [3].
d. Evonik Industries (Germany)
Evonik supplies pharmaceutical-grade potassium chloride through their specialty chemicals division. Their API manufacturing adheres to strict EU standards, providing high purity products with stability for injectable formulations [4].
2. Finished Formulation Manufacturers
a. Baxter International Inc.
Baxter produces IV formulations containing potassium chloride 40mEq, supplied in sterile, pre-filled infusion containers. Their extensive distribution network ensures timely availability globally, with a focus on compliance with US and EU regulations [5].
b. Pfizer Inc.
Pfizer offers intravenous potassium chloride in various concentrations, including 40mEq, utilizing their advanced manufacturing facilities. Their global presence ensures supply chain reliability and regulatory compliance [6].
c. Hikma Pharmaceuticals
Hikma supplies sterile potassium chloride infusion solutions, with certifications from multiple regulatory bodies. They are known for ensuring consistent quality and widespread distribution, particularly in Middle Eastern, European, and North African markets [7].
d. Fresenius Kabi
Fresenius Kabi manufactures potassium chloride infusion bags, emphasizing high purity and stability suitable for clinical use. Their products are widely used across hospitals globally, adhering to strict GMP standards [8].
Regulatory and Quality Considerations
The suppliers mentioned above meet international standards, including US Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP). Regulatory compliance ensures the API and finished products' safety, efficacy, and quality. Procurement decisions often hinge upon certifications like ISO 9001, cGMP compliance, and Good Distribution Practices (GDP), particularly in the context of injectable pharmaceuticals.
Supply Chain Dynamics and Risks
The global supply chain for potassium chloride faces challenges such as geopolitical tensions, raw material shortages, and quality verification bottlenecks. Chinese API producers dominate the market, but recent geopolitical considerations prompt pharmaceutical companies to diversify sourcing. The COVID-19 pandemic accentuated vulnerabilities, leading to increased inventory buffering and reliance on multiple suppliers.
Compliance with regulatory standards and transparent sourcing practices are critical for risk mitigation. Contracting with established, globally certified manufacturers mitigates potential disruptions and ensures regulatory approval continuity.
Emerging Trends and Opportunities
The market is witnessing a shift towards dual sourcing strategies, development of stable, high-purity synthetic processes, and increased investments in API manufacturing in regions like India and Southeast Asia. Additionally, expanding oral formulations and stability-enhanced infusion solutions present growth opportunities for suppliers with innovation capabilities.
Furthermore, supply chain transparency initiatives, such as blockchain, are increasingly adopted to verify origin and ensure quality, particularly for injectable APIs like potassium chloride.
Conclusion
The supply landscape for potassium chloride 40mEq spans major API and formulation manufacturers globally. Suppliers like Fosun Pharma, Sinopharm, Indian API producers, Evonik, Baxter, Pfizer, Hikma, and Fresenius Kabi are key players, offering high-quality products compliant with international standards. Ensuring supply chain resilience involves diversification, stringent quality assurance, and adherence to regulatory compliance standards.
Key Takeaways
- Leading API suppliers include Fosun Pharma, Sinopharm, Indian producers, and Evonik, with global export capabilities.
- Formulation manufacturers like Baxter, Pfizer, Hikma, and Fresenius Kabi provide ready-to-use infusion solutions, supporting diverse healthcare systems.
- Regulatory compliance (USP, EP, GMP) is critical for quality assurance and market access.
- Supply chain risks involve geopolitical factors, raw material availability, and pandemic-related disruptions; diversification mitigates these risks.
- Emerging trends focus on manufacturing innovation, supply chain transparency, and expanding formulation options.
FAQs
1. What are the primary regions where suppliers of potassium chloride 40mEq are located?
Suppliers are predominantly based in China, India, Europe (Germany, France), and North America, with China and India leading global production due to cost advantages and capacity.
2. How do regulatory standards impact supplier selection for pharmaceutical potassium chloride?
Regulatory standards like USP, EP, and GMP certification ensure product safety, stability, and efficacy, making compliant suppliers essential for market access and patient safety.
3. Are there significant supply chain risks associated with sourcing potassium chloride API globally?
Yes, risks include geopolitical tensions, raw material shortages, regulatory changes, and pandemic-related disruptions. Diversification and quality assurance are vital mitigation strategies.
4. What factors influence the choice between API suppliers and finished formulation manufacturers?
Quality, regulatory compliance, supply reliability, cost, and lead times influence procurement decisions. API suppliers are chosen for control over formulation; finished manufacturers are preferred for immediate inventory needs.
5. Is there a trend toward regional manufacturing of potassium chloride?
Yes, to reduce supply chain risks, markets are encouraging regional API manufacturing capacities, especially in India and Southeast Asia, aligning with global regulatory standards.
References
[1] Fosun Pharma corporate website, 2023.
[2] Sinopharm Group Annual Report, 2023.
[3] Indian Pharmaceutical Market Overview, 2023.
[4] Evonik Industries Product Catalog, 2023.
[5] Baxter International Product Portfolio, 2023.
[6] Pfizer Corporate Reports, 2023.
[7] Hikma Pharmaceuticals Annual Report, 2023.
[8] Fresenius Kabi Product Line, 2023.
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