Suppliers and packagers for iosat

iosat

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Anbex	IOSAT	potassium iodide	TABLET;ORAL	018664	NDA	Anbex Inc.	51803-001-01	14 TABLET in 1 PACKAGE (51803-001-01)	1982-10-14
Anbex	IOSAT	potassium iodide	TABLET;ORAL	018664	NDA	Anbex Inc.	51803-001-10	10 PACKAGE in 1 BAG (51803-001-10) / 14 TABLET in 1 PACKAGE (51803-001-01)	1982-10-14
Anbex	IOSAT	potassium iodide	TABLET;ORAL	018664	NDA	Anbex Inc.	51803-002-01	20 TABLET in 1 PACKAGE (51803-002-01)	2013-05-01
Anbex	IOSAT	potassium iodide	TABLET;ORAL	018664	NDA	Anbex Inc.	51803-002-02	14 TABLET in 1 PACKAGE (51803-002-02)	2013-05-01

Last updated: July 30, 2025

ppliers for the Pharmaceutical Drug: IOSAT

Introduction
IOSAT is a well-known pharmaceutical product containing potassium iodide, chiefly used for radiation emergency preparedness and thyroid protection. It plays a pivotal role in radiation exposure management by saturating the thyroid gland with stable iodine, thereby preventingRadioiodine uptake during nuclear incidents. Considering its strategic importance, understanding IOSAT’s supply chain, including primary suppliers, manufacturing sources, and distribution channels, is essential for stakeholders involved in health preparedness, government procurement, and pharmaceutical distribution. This article explores the key suppliers of IOSAT, their manufacturing capacities, and market dynamics influencing the drug’s availability.

Overview of IOSAT and Its Importance
IOSAT is a patented formulation of potassium iodide (KI) designed for rapid administration in radiation emergencies. The drug is primarily marketed by Pfizer, a global pharmaceutical leader, under the brand name IOSAT or Thryoid. Its significance surged during nuclear crises, such as the Fukushima disaster in 2011 and concerns regarding nuclear proliferation. The U.S. Food and Drug Administration (FDA) approves IOSAT as an over-the-counter drug, underscoring its critical role in emergency preparedness.

Manufacturers and Primary Suppliers of IOSAT

Pfizer Inc.
Pfizer is the principal manufacturer and supplier of IOSAT in the United States and globally. As a multinational pharmaceutical giant, Pfizer’s production capacity for potassium iodide formulations is extensive, with manufacturing sites situated in the U.S., Europe, and other regions. Pfizer’s supply chain for IOSAT involves multiple facilities certified under Good Manufacturing Practices (GMP), ensuring the drug’s quality and regulatory compliance. The company maintains a strategic stockpile of IOSAT to meet government and emergency needs, especially following U.S. government contracts.

Contract Manufacturing Organizations (CMOs)
While Pfizer directly produces IOSAT, its supply chain includes partnerships with select CMOs in the pharmaceutical sector that facilitate large-scale manufacturing, packaging, and distribution. These CMOs are chosen for capacity, compliance, and quality standards, allowing Pfizer to scale production rapidly during emergencies. Notably, CMOs such as Pfizer’s own manufacturing plants are situated in North America and Europe, with some specialized in sterile pharmaceutical compounding.

Raw Material Suppliers
The critical raw material for IOSAT is high-purity potassium iodide (KI). Global suppliers of pharmaceutical-grade KI include companies such as BASF, Evonik Industries, and Merck KGaA. These firms produce potassium iodide through chemical synthesis or extraction methods, adhering to strict quality standards. The availability and price of pharmaceutical-grade KI can influence IOSAT manufacturing capacity and costs.

Distribution Channels and Stockpiling
The U.S. government, through agencies such as the Strategic National Stockpile (SNS) managed by the CDC, procures and stocks IOSAT for emergency use. Pfizer supplies to government contracts, which are then distributed nationwide through authorized pharmacies and healthcare providers. International agencies and governments also procure IOSAT via Pfizer or authorized distributors, ensuring stockpiles in nuclear-sensitive regions.

Other Potential Suppliers and Market Dynamics

While Pfizer remains the dominant manufacturer, the global demand for potassium iodide during nuclear emergencies, coupled with increased emphasis on preparedness, has spurred interest from other pharmaceutical firms. Currently, the market is constrained due to regulatory barriers, manufacturing complexity, and quality standards. However, burgeoning producers in China, India, and Europe are exploring similar formulations, which could diversify the supply landscape in the future.

Regulatory and Patent Considerations
The patent for IOSAT is held by Pfizer, securing exclusivity in many markets. During patent exclusivity, generic versions or competing formulations face regulatory hurdles. However, in many jurisdictions, generic potassium iodide formulations are available, often marketed under different brand names. These alternatives, while chemically equivalent, may not be formally approved or marketed as IOSAT, impacting supply reliability.

Supply Chain Challenges and Market Factors

• Regulatory Barriers: Certification under authoritative bodies such as the FDA, EMA, or WHO is critical, limiting the number of qualified suppliers.
• Raw Material Scarcity: Disruptions in KI supply chains can impede manufacturing, especially amid global geopolitical tensions affecting raw material trade.
• Market Demand Surges: Emergency situations, policy changes, or enhanced preparedness initiatives translate into spikes in demand, challenging supply stability.
• Manufacturing Capacity Limits: The complexity of pharmaceutical-grade KI production constrains rapid scale-up, especially without prior stockpile agreements.

Conclusion
Pfizer remains the primary and most reliable supplier of IOSAT, supported by a network of manufacturing facilities, CMOs, and raw material providers. While alternative suppliers exist globally, their regulatory approval status and manufacturing capacity limit widespread availability. Stakeholders should monitor ongoing developments in raw material sourcing, regulatory changes, and geopolitical influences that could impact IOSAT’s supply chain stability. Strategic procurement and inventory management are crucial to ensuring readiness for radiation emergencies.

Key Takeaways

• Pfizer dominates the IOSAT supply chain, with extensive manufacturing capacity and established distribution channels.
• Raw material sourcing for potassium iodide significantly influences production, with major suppliers including BASF and Merck.
• Regulatory compliance and quality standards act as barriers to entry for new suppliers, limiting market competition.
• Global demand fluctuations and supply chain disruptions pose ongoing challenges; proactive stockpiling remains essential.
• Emerging producers in Asia and Europe may diversify the supply landscape, but regulatory hurdles must be navigated.

FAQs

1. Who is the primary manufacturer of IOSAT?
   Pfizer Inc. is the exclusive manufacturer and primary supplier of IOSAT worldwide, leveraging its extensive pharmaceutical manufacturing infrastructure.

2. Can other companies supply potassium iodide as an alternative to IOSAT?
   Yes, generic potassium iodide formulations are available from multiple pharmaceutical producers, but these are not marketed under the IOSAT brand and may lack FDA approval or the same regulatory clearance.

3. What raw materials are used in IOSAT production?
   The key raw material is pharmaceutical-grade potassium iodide, supplied by chemical manufacturing companies like BASF, Merck, and Evonik Industries.

4. Are there geopolitical factors affecting IOSAT supply?
   Yes, trade restrictions, raw material sourcing, and geopolitical tensions can impact supply chains, particularly for raw materials and manufacturing components.

5. What strategies can stakeholders employ to ensure steady IOSAT availability?
   Maintaining strategic stockpiles, diversifying procurement sources, engaging in government procurement programs, and monitoring regulatory approvals are essential strategies.

References
[1] U.S. Food and Drug Administration. “Potassium Iodide (KI) Tablets.” FDA.gov, https://www.fda.gov.
[2] Pfizer. “About Pfizer: Products and Pipeline.” Pfizer.com, https://www.pfizer.com.
[3] Strategic National Stockpile. “Radiation Emergency Preparedness.” CDC.gov, https://www.cdc.gov.
[4] European Medicines Agency. “Regulatory Guidelines for Potassium Iodide.” EMA.europa.eu, https://www.ema.europa.eu.
[5] Market analysis reports on pharmaceutical raw materials, 2022.