Suppliers and packagers for POTASSIUM IODIDE

POTASSIUM IODIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mission Pharmacal	POTASSIUM IODIDE	potassium iodide	SOLUTION;ORAL	206211	ANDA	Mission Pharmacal Company	0178-0314-30	1 BOTTLE, DROPPER in 1 CARTON (0178-0314-30) / 30 mL in 1 BOTTLE, DROPPER	2016-05-15

Suppliers for the Pharmaceutical Drug: Potassium Iodide

Last updated: July 29, 2025

Introduction

Potassium Iodide (KI) is an essential pharmaceutical compound used primarily for thyroid protection in nuclear emergencies, as an iodine deficiency remedy, and in various medical applications. Due to its critical role in radiation emergencies and widespread medical use, demand for high-quality, reliable suppliers is robust. This article offers a comprehensive review of prominent suppliers, analyzing their manufacturing capabilities, regulatory compliance, and market positioning, to guide pharmaceutical companies, healthcare providers, and emergency preparedness agencies in sourcing.

Global Manufacturing Landscape

Leading Producers of Potassium Iodide

Major suppliers of pharmaceutical-grade potassium iodide are concentrated in North America, Europe, and Asia, with several longstanding pharmaceutical and chemical manufacturers maintaining significant inventories.

1. Merck KGaA (Germany)

Merck, a global leader in healthcare and life sciences, supplies pharmaceutical-grade potassium iodide, renowned for compliance with international standards such as USP, EP, and JP. Their manufacturing processes emphasize strict quality control, ensuring purity levels exceeding 99%. Merck’s global distribution network makes it a prime supplier for international markets seeking reliable, high-purity potassium iodide.

2. Sigma-Aldrich (Merck Group) (USA/Germany)

Sigma-Aldrich, a subsidiary of Merck, offers pharmaceutical-grade potassium iodide for both research and pharmaceutical use. Their products comply with USP and EP standards, boasting consistent batch quality. Their extensive distribution infrastructure ensures timely supply for hospitals, clinics, and emergency agencies.

3. AkzoNobel (Netherlands)

While primarily known for chemicals, AkzoNobel produces pharmaceutical-grade potassium iodide, mainly targeted for medical applications. Their facilities meet rigorous quality standards applicable to pharmaceutical ingredients, and they emphasize sustainable manufacturing processes.

4. Baxter International (USA)

Baxter sources potassium iodide for medical formulations, especially for injection-grade applications. Their supply chain focuses on reliability and adherence to Good Manufacturing Practices (GMP), making them a significant contributor to pharmaceutical-grade potassium iodide supplies in North America.

Regional and Emerging Suppliers

5. Jiangsu Nuohua Pharmaceutical (China)

A prominent Chinese manufacturer, Jiangsu Nuohua supplies pharmaceutical-grade potassium iodide, increasingly recognized for cost competitiveness and increasing global export volume. They adhere to CN-GMP standards and are certified for ISO 9001, serving Asian, African, and Latin American markets.

6. Hubei Yitai Pharmaceutical (China)

This Chinese manufacturer offers high-purity potassium iodide for medical and emergency use. Their manufacturing processes align with international standards, and they focus on expanding their global footprint.

Specialized Suppliers

Some companies focus on niche markets such as nuclear safety responders and bulk chemical distributors. These include:

• ROCOLUSA: Offers bulk potassium iodide for emergency preparedness kits, emphasizing rapid shipping and regulatory compliance.
• Fisher Scientific: Supplies USP-grade potassium iodide in various packaging sizes, catering primarily to hospitals and laboratories.

Regulatory and Quality Considerations

Ensuring the purity, stability, and compliance of potassium iodide is critical for pharmaceutical applications. Suppliers must meet strict regulatory standards, including:

• United States Pharmacopeia (USP) Standards
• European Pharmacopoeia (EP)
• Japanese Pharmacopoeia (JP)
• ISO Certification

Leading suppliers invest heavily in quality assurance processes, including:

• Batch testing for purity and contaminant levels
• GMP certified manufacturing facilities
• Consistent documentation and traceability

Supply Chain and Sourcing Strategies

Given the criticality of potassium iodide, especially in nuclear emergencies, organizations should prioritize suppliers with:

• Proven regulatory compliance
• Robust quality management systems
• Capable logistic networks for emergency redistribution
• Proven track record of supply continuity during crises

Diversifying suppliers across regions minimizes risk of disruption due to geopolitical issues, natural disasters, or manufacturing shutdowns.

Market Trends & Future Outlook

The demand for pharmaceutical-grade potassium iodide is expected to grow steadily due to increased preparedness for radiological incidents and expanded medical use. Notably:

• Governments worldwide stockpile potassium iodide, influencing procurement trends.
• The rising incidence of iodine deficiency diseases sustains steady demand in developing nations.
• Supply chain pressures from geopolitical tensions, especially involving China, could impact availability.

Investment in manufacturing capacity expansion and regulatory standard harmonization remains vital for suppliers to meet future needs.

Conclusion

A reliable supply of pharmaceutical-grade potassium iodide hinges on choosing suppliers adhering to high regulatory standards, ensuring product purity, and maintaining robust logistical capabilities. Established players like Merck and Sigma-Aldrich dominate the global market, supported by extensive quality controls and regulatory compliance, while emerging Chinese manufacturers present cost-effective alternatives with expanding international reach. Strategic sourcing, supplier diversification, and adherence to regulatory standards are essential to maintain supply security in both medical emergencies and routine applications.

Key Takeaways

• Major global suppliers include Merck KGaA, Sigma-Aldrich, Baxter, and Chinese manufacturers such as Jiangsu Nuohua Pharmaceutical.
• Quality compliance with USP, EP, and JP standards remains critical for pharmaceutical-grade potassium iodide.
• Supply chain resilience benefits from diversified sourcing and partnerships with suppliers capable of rapid, large-volume distributions.
• Emerging markets and geopolitical factors may influence supply and pricing, requiring proactive procurement strategies.
• Future demand growth supports investment in manufacturing capacity and regulatory harmonization to ensure availability.

FAQs

Q1: What are the primary applications of pharmaceutical-grade potassium iodide?
A1: It is used for thyroid protection in nuclear emergencies, iodine deficiency treatment, and as an adjunct in certain medical conditions like hyperthyroidism.

Q2: What standards should I look for in sourcing pharmaceutical potassium iodide?
A2: Ensure the supplier complies with pharmacopoeia standards such as USP, EP, or JP, and maintains GMP certification.

Q3: Which regions dominate the production of pharmaceutical-grade potassium iodide?
A3: North America, Europe, and China are the primary manufacturing hubs, with China emerging as a significant supplier in recent years.

Q4: What are the risks associated with sourcing potassium iodide internationally?
A4: Risks include supply chain disruptions, regulatory differences, quality variability, and geopolitical tensions affecting trade.

Q5: How can organizations ensure the quality of potassium iodide from new suppliers?
A5: Verify certifications, review batch testing reports, conduct supplier audits, and establish quality agreements detailing testing and compliance requirements.

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Sources:

[1] US Pharmacopeia (USP) Standards.
[2] European Pharmacopoeia (EP).
[3] Japanese Pharmacopoeia (JP).
[4] Merck KGaA Corporate Website.
[5] Sigma-Aldrich Product Catalog.
[6] GlobalData and industry procurement reports.