Suppliers and packagers for generic pharmaceutical drug: ISOFLURANE

ISOFLURANE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	FORANE	isoflurane	LIQUID;INHALATION	017624	NDA	Baxter Healthcare Corporation	10019-360-40	6 BOTTLE, GLASS in 1 PACKAGE (10019-360-40) / 100 mL in 1 BOTTLE, GLASS	1979-12-18
Baxter Hlthcare	FORANE	isoflurane	LIQUID;INHALATION	017624	NDA	Baxter Healthcare Corporation	10019-360-60	6 BOTTLE, GLASS in 1 PACKAGE (10019-360-60) / 250 mL in 1 BOTTLE, GLASS	1979-12-18
Halocarbon Prods	ISOFLURANE	isoflurane	LIQUID;INHALATION	075225	ANDA	Halocarbon Life Sciences, LLC	12164-012-10	100 mL in 1 BOTTLE, GLASS (12164-012-10)	1999-10-20

Suppliers for the Pharmaceutical Drug: Isoflurane

Last updated: July 27, 2025

Introduction

Isoflurane, a volatile inhalational anesthetic agent, is widely used in surgical procedures to induce and maintain anesthesia. As a highly regulated pharmaceutical, the sourcing and supply chain integrity are critical to ensure consistent availability, safety, and compliance with international standards. This article examines key suppliers of isoflurane, considering market dynamics, manufacturing capabilities, geographic distribution, and regulatory considerations vital for stakeholders in the healthcare and pharmaceutical sectors.

Market Overview

The global market for inhalational anesthetics, including isoflurane, is characterized by a limited number of specialized manufacturers primarily concentrated in North America, Europe, and Asia. The consolidation reflects stringent regulatory requirements, high manufacturing expertise, and safety standards necessary to produce inhalational anesthetics. The demand for isoflurane hinges on anesthesia practices globally, with an increasing shift towards safer, vaporization-based agents compared to older agents like halothane.

Major Suppliers of Isoflurane

1. Abbott Laboratories (AbbVie)

Abbott Laboratories, now operating as AbbVie post-2013, has historically been a significant producer of isoflurane. Its product, Forane®, is one of the most globally recognized brands. Abbott's manufacturing facilities in the United States and Europe adhere to Good Manufacturing Practices (GMP), ensuring high-quality standards.

AbbVi e’s extensive distribution network facilitates supply across North America, Europe, Asia, and other regions. Their strategic global presence makes them a pivotal player in the isoflurane supply chain, especially for hospitals and surgical centers seeking reliable procurement sources.

2. Hikma Pharmaceuticals

Hikma Pharmaceuticals, headquartered in London with manufacturing plants in the Middle East and North Africa, has become a critical supplier of isoflurane, particularly in emerging markets. Their product line includes Isoflurane Hikma, fulfilling regional demand in Africa, the Middle East, and parts of Asia.

Hikma's manufacturing facilities are GMP-compliant, with a focus on affordable, high-quality anesthetic agents. Their strategic positioning enables them to fill supply gaps in developing regions, often competing on price and accessibility.

3. Piramal Enterprises

India-based Piramal Enterprises is a leading manufacturer of pharmaceutical commodities, including inhaled anesthetics like isoflurane. Their facilities are situated in key pharmaceutical hubs such as Gujarat, ensuring adherence to international standards and efficient export capabilities.

Piramal supplies to various emerging markets in Asia, Africa, and Latin America, often serving as a cost-effective alternative to Western suppliers. Their focus on quality and regulatory compliance has expanded their global footprint.

4. Jiangsu Hengrui Medicine Co., Ltd.

This Chinese pharmaceutical company has rapidly expanded its portfolio into anesthetic agents, including isoflurane. Jiangsu Hengrui’s infrastructure emphasizes research and development, with GMP-certified manufacturing plants producing high-purity isoflurane for domestic and export markets.

Their ascendancy reflects China's broader goal of becoming a major global supplier of pharmaceutical ingredients, with a focus on competitive pricing and regulatory compliance, including CE marking and other certifications.

5. Patheon (Thermo Fisher Scientific)

Part of Thermo Fisher Scientific, Patheon operates several manufacturing sites globally, with capabilities for producing inhalational anesthetic agents such as isoflurane under strict GMP conditions. While primarily a contract manufacturing organization (CMO), their role often involves custom formulations and licensing agreements with brand-name producers.

This integration ensures consistent supply for clients requiring OEM or generic market access, especially within North America and Europe.

Emerging and Niche Suppliers

Beyond established giants, smaller regional manufacturers are increasing their foothold by leveraging advances in synthesis methods and regulatory approval pathways. Countries like South Korea, Brazil, and Germany are witnessing burgeoning local manufacturers aiming to meet domestic demand and export requirements. These suppliers often focus on cost-competitiveness while maintaining compliance with stringent safety standards.

Regulatory Considerations

Suppliers must navigate complex regulatory landscapes owing to the classified nature of inhalational anesthetics. The approval of isoflurane requires adherence to the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national agencies' standards. Regulatory compliance impacts supplier selection, emphasizing track record, GMP certification, and quality assurance protocols.

Supply Chain Risks and Opportunities

Supply chain disruptions, such as manufacturing shortages or logistical bottlenecks, can compromise isoflurane availability. A concentration of production in specific regions poses geopolitical and environmental risks. Diversifying suppliers, including regional manufacturers, mitigates such risks.

Opportunities lie in innovations to enhance manufacturing efficiency, reduce costs, and expand regional manufacturing bases, especially as global anesthesia demand grows alongside healthcare infrastructure development.

Conclusion

The primary suppliers of isoflurane—Abbott Laboratories, Hikma Pharmaceuticals, Piramal Enterprises, Jiangsu Hengrui Medicine, and Patheon—constitute a robust, albeit concentrated, supply chain. Their combined manufacturing scales, regulatory adherence, and geographic distribution underpin global access to this critical anesthetic agent.

Stakeholders must engage with suppliers demonstrating high compliance, reliable supply track records, and strategic regional presence. Emphasizing diversification and quality assurance will fortify supply resilience in a market sensitive to regulatory and geopolitical shifts.

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Key Takeaways

• Dominant players include Abbott (AbbVie), Hikma Pharmaceuticals, Piramal Enterprises, Jiangsu Hengrui, and Patheon, offering extensive geographic coverage and manufacturing expertise.
• Regulatory compliance remains a crucial criterion, with GMP certification and adherence to global standards dictating supplier credibility.
• Regional diversification mitigates risks associated with supply disruptions, emphasizing the importance of engaging with regional manufacturers in emerging markets.
• Innovation and capacity expansion present growth avenues, aligning with rising global demand for safe and effective anesthetic agents.
• Supply chain resilience depends on balancing cost, quality, and geopolitical considerations, especially amid global health crises and market fluctuations.

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FAQs

1. Who are the top global suppliers of isoflurane?
The leading suppliers are Abbott Laboratories (AbbVie), Hikma Pharmaceuticals, Piramal Enterprises, Jiangsu Hengrui Medicine, and Thermo Fisher Scientific’s Patheon division.

2. What are some regulatory challenges suppliers of isoflurane face?
Suppliers must meet stringent GMP standards set by authorities like the FDA and EMA, ensure product purity, and obtain necessary approvals for international distribution, which can delay or restrict market access.

3. How does regional manufacturing affect isoflurane supply security?
Regional production enhances supply resilience by reducing dependence on distant suppliers, minimizing logistical disruptions, and complying with local regulations, though it requires maintaining high quality standards.

4. Are there emerging markets for isoflurane manufacturing?
Yes, countries like China, India, South Korea, and Brazil are increasing their production capacity, driven by growing healthcare infrastructure and government support for pharmaceutical self-sufficiency.

5. What risks could impact future isoflurane supplies?
Manufacturing shortages, geopolitical tensions, environmental disasters, and regulatory changes pose risks. Supply chain diversification and technological innovations are strategies to mitigate these risks.

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References

[1] MarketsandMarkets. Inhalational Anesthetics Market by Product, Application, Route of Administration, and Region — Global Forecast to 2025.
[2] Abbott Laboratories. Forane® (Isoflurane) Product Information.
[3] Hikma Pharmaceuticals. Product Portfolio & Global Operations Overview.
[4] Piramal Enterprises. Pharmaceutical Manufacturing Capabilities.
[5] Jiangsu Hengrui Medicine Co., Ltd. Corporate Reports and GMP Certifications.