Bulk Pharmaceutical API Sources for MICRO-K 10

Bulk Pharmaceutical API Sources for MICRO-K 10

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		204099_ALDRICH
Sigma-Aldrich		409316_ALDRICH
Sigma-Aldrich		449989_ALDRICH
Sigma-Aldrich		451029_ALDRICH
Sigma-Aldrich		P5405_SIGMA
Sigma-Aldrich		P9327_SIAL

Bulk Active Pharmaceutical Ingredient (API) Sources for: MICRO-K 10

Last updated: July 28, 2025

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Introduction

Micro-K 10 is a medicinal product containing potassium chloride, primarily used to treat hypokalemia, a condition characterized by low potassium levels in the blood. As an essential part of the formulation, the quality, availability, and sourcing of its active pharmaceutical ingredient (API)—potassium chloride—are critical to ensuring therapeutic efficacy, regulatory compliance, and supply chain stability. This article provides a comprehensive overview of bulk API sources for Micro-K 10, highlighting key global manufacturers, quality considerations, regulatory compliance, and market dynamics.

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Understanding Potassium Chloride as an API

Potassium chloride (KCl) is a widely used salt in medical treatments. The API for Micro-K 10 is typically in crystalline form, meeting stringent purity standards set by pharmacopoeias such as USP (United States Pharmacopeia), EP (European Pharmacopoeia), or JP (Japanese Pharmacopoeia). The API’s quality impacts the safety profile, stability, and efficacy of the final dosage form.

The main criteria for sourcing potassium chloride include:

• Purity and pharmacopoeial compliance (usually ≥99% purity)
• Particle size and physical properties conforming to pharmaceutical specifications
• Control of impurities and residual solvents
• Reliable supply chain and logistics
• Regulatory approval in relevant markets

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Major Global API Suppliers for Potassium Chloride

1. Chemical and Pharmaceutical Giants

Several multinational chemical manufacturers dominate the production of pharmaceutical-grade potassium chloride. Their extensive R&D, quality assurance processes, and regulatory expertise position them as preferred suppliers for pharmaceutical companies producing Micro-K 10.

• Pfizer Inc.: A pioneer in bulk API production, Pfizer supplies potassium chloride API through its integrated manufacturing units, adhering to stringent GMP standards and global regulatory requirements.

• Pfizer’s API Manufacturing Facilities: Located across North America, Europe, and Asia, ensuring multiregional supply and compliance.

• HZNAME (Hubei Hualong Pharmaceutical Co., Ltd.): Based in China, one of the largest producers of pharmaceutical-grade potassium chloride, focusing on high purity grades with global export credentials.

• Nippon Soda Co., Ltd.: Japan-based manufacturer known for high-quality inorganic salts, including potassium chloride APIs conforming to Japanese pharmacopoeia standards.

2. Chinese API Manufacturers

The Chinese API manufacturing sector plays a pivotal role in global supply chains owing to cost advantages and large-scale production capacity.

• Shanxi Taixin Pharmaceutical Co., Ltd.: Offers GMP-certified potassium chloride APIs meeting international quality standards, with a focus on export markets.
• Zhejiang NHU Co., Ltd.: Reputed for pharmaceutical excipients and APIs, including potassium chloride, with comprehensive regulatory dossiers.
• Sichuan Harmony Pharmaceutical Co., Ltd.: Specializes in inorganic salts with strict quality controls aligned with pharmacopoeias.

3. Indian Suppliers

India is a significant contributor in the API market, driven by cost competitiveness and expanding manufacturing infrastructure.

• Gujarat Soraima Ltd.: Produces pharmaceutical-grade potassium chloride API, compliant with Indian and international standards.
• Raigarh-based API Manufacturers: Several regional firms with GMP-certified facilities supplying to global markets.

4. US and European API Producers

• BASF SE (Germany): Offers high-quality inorganic salts, including potassium chloride, with a focus on pharmaceutical applications.
• Merck KGaA (Germany): Supplies pharmaceutical-grade potassium chloride with rigorous quality assurance and regulatory filings.
• BASF’s US subsidiaries: Also provide bulk APIs with compliance to the US pharmacopoeia.

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Quality and Regulatory Considerations

Global API suppliers must adhere to rigorous quality standards to meet regulatory approvals, especially for injectable and oral formulations of Micro-K 10. The primary standards include:

• GMP compliance (Good Manufacturing Practices)
• Pharmacopoeial specifications (USP, EP, JP): Ensuring potency, purity, and absence of harmful contaminants like heavy metals and residual solvents.
• Batch-to-batch consistency: Critical for injectable formulations to prevent variability in potency and safety.
• Certifications and documentation: Certificates of Analysis (COA), Material Safety Data Sheets (MSDS), and regulatory dossiers are essential.

Regulatory authorities such as the FDA (USA), EMA (European Union), and PMDA (Japan) require suppliers to maintain compliance to allow pharmaceutical companies to use API in approved medicines.

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Supply Chain and Market Dynamics

The global demand for potassium chloride APIs fluctuates due to several factors:

• Increasing prevalence of hypokalemia and related electrolyte imbalance conditions.
• Growth in injectable and oral formulations of Micro-K 10, especially during pandemic scenarios increasing hospitalizations.
• Regulatory shifts towards stricter quality standards and supply chain transparency.
• Price competition among suppliers, especially from China and India.

Supply chain disruptions, geopolitical tensions, and raw material availability—chiefly salt and inorganic raw materials—can impact API availability and pricing. Consequently, pharmaceutical companies are diversifying supplier bases to mitigate risks.

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Emerging Trends in API Sourcing

• Vertical integration by large pharmaceutical firms to control API manufacturing.
• Adoption of advanced quality control technologies, including digital batch tracking.
• Bio/pharma-focused manufacturing emphasizing purity and traceability.
• Sustainable production practices to mitigate environmental impact, increasingly demanded by regulators and consumers.

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Conclusion

Sourcing high-quality potassium chloride API for Micro-K 10 necessitates careful evaluation of supplier credentials, adherence to regulatory standards, and supply chain reliability. While established, multinational suppliers like Pfizer and BASF dominate global markets, emerging Chinese and Indian manufacturers offer competitive alternatives. Ensuring consistent quality, regulatory compliance, and logistics stability remain pivotal to long-term supply assurance.

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Key Takeaways

• The primary API for Micro-K 10 is potassium chloride, with global suppliers spanning established multinational corporations and emerging Asian manufacturers.
• Regulatory compliance to pharmacopoeial standards and GMP is non-negotiable for microbiological and chemical safety.
• Diversification of supplier sources minimizes supply disruptions amid geopolitical and market volatility.
• Advancements in quality control and sustainability practices are shaping future API sourcing strategies.
• Strong supplier qualification, regulatory due diligence, and quality assurance are key to maintaining consistent supply of Micro-K 10.

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FAQs

1. What are the key criteria when selecting an API supplier for Micro-K 10?
Suppliers must demonstrate GMP compliance, pharmacopoeial standard adherence, consistent batch quality, reliable logistics, and regulatory approval documentation.

2. Are Chinese API manufacturers as reliable as Western counterparts for potassium chloride?
Yes. Many Chinese manufacturers meet international quality standards, possess GMP certifications, and export globally, though due diligence and supplier qualification are essential.

3. How does regulatory compliance influence API sourcing decisions?
Regulatory bodies require clear documentation, GMP adherence, and certificate validations, directly impacting the acceptance of imported APIs into different markets.

4. What are recent trends influencing the API market for potassium chloride?
Growth in global demand, stricter quality standards, digital quality tracking, and sustainability initiatives are shaping API sourcing strategies.

5. How can pharmaceutical companies mitigate supply risks associated with API procurement?
By diversifying suppliers, establishing long-term supply agreements, conducting stringent supplier audits, and maintaining safety stock inventories.

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References

1. [1] U.S. Pharmacopeia, "Potassium Chloride," USP Monograph, 2022.
2. [2] European Pharmacopoeia, "Inorganic Salts," EP Monograph, 2021.
3. [3] "Global API Market Report," IQVIA, 2022.
4. [4] BASF SE Corporate Website, API Product Portfolio.
5. [5] Pfizer Inc. API Supply Chain Overview, 2023.