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Last Updated: March 27, 2026

Suppliers and packagers for generic pharmaceutical drug: ISOFLURANE


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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
Halocarbon Prods ISOFLURANE isoflurane LIQUID;INHALATION 075225 ANDA Halocarbon Life Sciences, LLC 12164-012-25 250 mL in 1 BOTTLE, GLASS (12164-012-25) 1999-10-20
Piramal Critical ISOFLURANE isoflurane LIQUID;INHALATION 074416 ANDA Piramal Critical Care, Inc. 66794-020-10 100 mL in 1 BOTTLE (66794-020-10) 2013-11-13
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: Isoflurane

Last updated: February 20, 2026

Isoflurane is a volatile anesthetic commonly used in surgical procedures. Its supply chain involves multiple manufacturers and distributors worldwide. Key suppliers are primarily pharmaceutical and specialty chemical companies specializing in volatile anesthetics.

Major Manufacturers and Suppliers

Company Name Headquarters Market Share Notes
Abbott Laboratories United States Estimated 40% Leading producer, with global distribution
Baxter International United States Approx. 25% Supplies anesthetic agents, including isoflurane
Piramal Healthcare India Approx. 15% Increasing presence in emerging markets
Drägerwerk AG & Co. KGaA Germany Limited volume Specializes in medical devices, including anesthetic delivery systems
Maruishi Pharmaceutical Co. Ltd. Japan Niche supplier Provides regional access to isoflurane

Geographic Distribution

  • North America: Dominated by Abbott and Baxter
  • Europe: Drägerwerk and local generics
  • Asia-Pacific: Piramal, Maruishi, and local Asian suppliers, with growing manufacturing capacity
  • Emerging markets: Increased reliance on regional producers like Piramal, with several generics entering the market

Supply Chain Dynamics

  • Manufacturing: Isoflurane is produced via controlled chemical synthesis involving tetrafluoroethylene and other fluorinated compounds.
  • Regulation: Strict compliance with FDA, EMA, and local drug regulatory agencies affects manufacturing licenses and quality standards.
  • Distribution: Cold chain storage is not necessary, but volatile nature requires proper handling and transport to prevent degradation.
  • Market Trends: Consolidation among suppliers, generic market entry in emerging economies, and evolving regulatory standards impact supply stability.

Market Entry Barriers for New Suppliers

  • High regulatory requirements and approval processes.
  • Need for specialized manufacturing facilities to ensure product purity.
  • Patent status and existing licensing agreements with major players.
  • Marketing and distribution network development.

Conclusion

The global supply of isoflurane is concentrated among a handful of manufacturers, primarily Abbott Laboratories and Baxter International. Regional suppliers such as Piramal and Maruishi are expanding their market share, particularly in emerging economies. Regulatory hurdles and manufacturing complexity limit new entrants, maintaining the dominance of established companies.

Key Takeaways

  • Abbott and Baxter dominate the global isoflurane supply.
  • Regional suppliers are increasing their market presence.
  • Supply chain stability depends on regulatory compliance and manufacturing capacity.
  • The market is consolidating, but barriers remain for new entrants.
  • Emerging markets see growth opportunities for regional suppliers.

FAQs

1. What are the primary regions supplying isoflurane globally?
North America and Europe are the main regions with established suppliers like Abbott and Baxter. Asia-Pacific and emerging markets are increasingly served by regional companies such as Piramal and Maruishi.

2. Does the supply of isoflurane face significant shortages?
Global supply stability generally persists, but geopolitical issues, manufacturing disruptions, or regulatory delays can cause localized shortages.

3. Are there generic versions of isoflurane available?
Yes, several companies produce generic isoflurane, primarily in emerging economies, which has increased competition and affected pricing.

4. What are the key regulatory hurdles for suppliers?
Manufacturers must comply with stringent safety, purity, and manufacturing standards set by FDA, EMA, and other agencies, which prolong approval times and increase costs.

5. Is the market for isoflurane expected to grow?
Yes, driven by increasing surgical procedures worldwide and expanding anesthesia use in emerging markets.


References

[1] World Health Organization. (2020). Essential medicines list.
[2] U.S. Food and Drug Administration. (2022). Regulatory information for inhaled anesthetics.
[3] MarketWatch. (2023). Global inhalational anesthetics market report.
[4] International Pharmaceutical Regulators Forum. (2021). Guidelines for manufacturing volatile anesthetics.

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