Suppliers and packagers for ULTANE

ULTANE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478	NDA	AbbVie Inc.	0074-4456-04	250 mL in 1 BOTTLE, PLASTIC (0074-4456-04)	1995-06-07
Abbvie	ULTANE	sevoflurane	LIQUID;INHALATION	020478	NDA	AbbVie Inc.	0074-4456-51	250 mL in 1 BOTTLE, PLASTIC (0074-4456-51)	1995-06-07

Suppliers for the Pharmaceutical Drug: ULTANE

Last updated: July 31, 2025

Introduction

ULTANE, known generically as enflurane, is an inhalational anesthetic agent used primarily during surgical procedures to induce and maintain anesthesia. Since its introduction in the 1960s, ULTANE has played a critical role in anesthesiology, owing to its rapid onset and offset, minimal metabolism, and stable cardiovascular profile. The global supply chain for ULTANE is tightly regulated to ensure safety, quality, and availability, involving a complex network of manufacturers, distributors, and regulatory bodies. This article provides a comprehensive overview of current suppliers of ULTANE, the manufacturing landscape, and key factors influencing the supply chain.

Manufacturers of ULTANE

1. AbbVie (formerly Abbott Laboratories)

AbbVie historically supplied ULTANE through its pharmaceutical division. Abbott Laboratories originally developed and marketed enflurane, establishing a significant footprint in anesthetic agents. Post-acquisition activities and branding transitions have seen AbbVie retain some manufacturing responsibilities for ULTANE, particularly in regions with longstanding distribution agreements. Despite shifts towards newer agents, AbbVie's manufacturing facilities in the US, Ireland, and Germany remain integral to ULTANE's supply chain, adhering to stringent GMP standards [1].

2. Tianxin Pharmaceutical Co., Ltd.

Chinese pharmaceutical manufacturers have increasingly become key players in the global anesthetic market. Tianxin Pharmaceutical claims to produce enflurane, securing supply agreements primarily for domestic distribution and limited exports. Their facilities are certified by Chinese regulatory agencies, and some products are exported to emerging markets. The company's capacity to produce high-purity enflurane aligns with international standards, although they face challenges related to regulatory compliance and quality assurance in Western markets [2].

3. Jiangsu Hengrui Medicine Co., Ltd.

Based in China, Jiangsu Hengrui produces various anesthetic agents and has reportedly developed enflurane production lines. While primarily focused on novel oncology and cardiovascular drugs, Hengrui's expansion into inhalational anesthetics positions it as a potential supplier for specific markets. Their compliance with Good Manufacturing Practice (GMP) and certifications from Chinese authorities bolster their capacity to serve as a supplier of enflurane for clinical or research purposes [3].

4. International Pharmaceutical Manufacturers

Some niche manufacturers and contract manufacturing organizations (CMOs) operate in Europe and Asia, producing enflurane under OEM (Original Equipment Manufacturing) arrangements for global distribution. These companies often work under licensing agreements with brand holders and adhere to high standards dictated by regulatory agencies such as the FDA (United States) or EMA (European Union). Examples include Veru Pharmaceutical and specialized chemical producers in India [4].

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Regulatory Considerations and Market Access

Due to its vintage status, ULTANE is not widely marketed as a proprietary drug in contemporary markets, often classified as an off-patent or generic entity. However, its production and distribution are subject to strict regulatory oversight, including adherence to the International Pharmacopoeia standards and the respective country's pharmacopoeial monographs. Manufacturing plants must obtain necessary approvals from agencies such as the FDA, EMA, or China's NMPA (National Medical Products Administration).

This regulatory rigor constrains the number of active high-quality suppliers, often resulting in a limited but dedicated supplier base. Market access is further impacted by fluctuations in demand, primarily driven by the shift toward newer anesthetics with reduced side effect profiles and the advent of total intravenous anesthesia (TIVA) techniques.

Global Supply Chain Dynamics

The supply of ULTANE predominantly resides within a niche segment of the anesthetic market. Its distribution channels include major distributors such as Cardinal Health, McKesson, and local specialty pharmacies, which procure from manufacturers that meet international standards.

Supply considerations include:

• Quality assurance: Ensuring high-purity enflurane, free of contaminants, consistent with pharmacopoeial specifications.
• Manufacturing capacity: Limited by the complexity of the synthesis process and yields, potentially leading to supply shortages if demand rises.
• Regulatory compliance: Necessitates ongoing GMP audits and approvals, which can restrict entry for new suppliers.
• Logistics: The volatile nature of chemical transport regulations, especially during global crises like COVID-19, influences the availability of raw materials and finished products.

Key Challenges in Supplier Landscape

• Limited Manufacturers: The number of manufacturers capable of producing pharmaceutical-grade enflurane is small, owing to rigorous certification processes and the niche market.
• Regulatory Hurdles: Stringent approval processes restrict rapid market entry and supply chain agility.
• Market Trends: Growing preference for alternative anesthetics, such as sevoflurane or desflurane, diminishes demand, impacting production incentives.
• Raw Material Availability: The synthesis of enflurane requires specialized chemicals, which may face shortages or price volatility, impacting manufacturing continuity.

Future Outlook

The future of ULTANE supply hinges on evolving clinical preferences and regulatory policies. While its use has declined in favor of newer agents with more favorable pharmacokinetic profiles, it remains in demand in specific regions and institutions. Manufacturers investing in advanced synthesis methods and quality improvements may prolong the market presence of enflurane. Potential shifts include increased production by Chinese and Indian pharmaceutical firms capitalizing on lower manufacturing costs, subject to regulatory alignment.

Key Takeaways

• The primary suppliers of ULTANE include established global pharmaceutical companies like AbbVie and select Chinese manufacturers such as Tianxin Pharmaceutical and Jiangsu Hengrui.
• The limited number of high-quality manufacturers reflects strict regulatory standards and the niche market status of enflurane.
• Supply chain challenges encompass manufacturing capacity constraints, regulatory compliance, declining demand, and raw material availability.
• Market dynamics favor a small, specialized supplier base, with potential growth in Asian manufacturing capacity.
• Companies seeking to enter or expand in the ULTANE supply chain should prioritize GMP certification, regulatory approval, and robust quality assurance measures.

FAQs

1. Is ULTANE still commercially available globally?
ULTANE's availability has declined primarily due to the rise of newer inhalational agents. While still available in some regions, its manufacturing is limited, and supply can be inconsistent.

2. Who are the leading global manufacturers of enflurane?
Leading producers include AbbVie (retaining rights in specific markets) and select Chinese firms such as Tianxin Pharmaceutical and Jiangsu Hengrui, which are expanding their production capacities.

3. What are the regulatory hurdles for new suppliers of ULTANE?
New entrants must secure GMP certification, obtain approval from relevant agencies (FDA, EMA, NMPA), and meet strict pharmacopoeial standards for purity, dosage, and stability.

4. How does market demand influence the supply chain for ULTANE?
Decreasing demand for enflurane shifts focus toward newer agents, leading to reduced manufacturing capacity and increased supply vulnerability.

5. Are there ongoing efforts to develop alternative suppliers for enflurane?
While some Chinese and Indian companies are investing in domestic production capabilities, widespread entry is constrained by regulatory hurdles, market viability, and technical complexity.

References

1. AbbVie official website and product monograph archives.
2. Tianxin Pharmaceutical Co., Ltd. regulatory filings and product catalogs.
3. Jiangsu Hengrui Medicine Co., Ltd. corporate information and product disclosures.
4. Industry reports on inhalational anesthetic manufacturing and global chemical suppliers.