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Suppliers and packagers for desflurane
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desflurane
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Shanghai Hengrui | DESFLURANE | desflurane | LIQUID;INHALATION | 208234 | ANDA | Sandoz Inc. | 0781-6172-86 | 6 BOTTLE, GLASS in 1 CARTON (0781-6172-86) / 240 mL in 1 BOTTLE, GLASS (0781-6172-22) | 2018-02-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Desflurane
Introduction
Desflurane, a volatile inhalational anesthetic, plays a pivotal role in modern surgical procedures due to its rapid onset and recovery profile. As a widely used anesthetic agent, its distribution and availability hinge on a robust network of manufacturers and suppliers. Understanding the landscape of Desflurane suppliers provides insight into market dynamics, supply chain stability, and opportunities for strategic partnerships. This analysis delves into the primary suppliers, manufacturing standards, regional distribution, and future trends related to Desflurane.
Overview of Desflurane Manufacturing and Supply Landscape
Desflurane is produced by several global pharmaceutical and chemical companies specializing in anesthetic agents. The manufacturing process involves complex chemical synthesis and strict adherence to regulatory standards, notably Good Manufacturing Practices (GMP). Since Desflurane is classified as a controlled substance in many jurisdictions owing to its anesthetic properties, suppliers must navigate rigorous regulatory compliance.
Major pharmaceutical companies engaged in Desflurane production include:
- AbbVie Inc. (formerly parts of Abbott Laboratories)
- Maruishi Pharmaceutical Co., Ltd.
- Maruishi Pharmaceutical Co., Ltd.
- Pfizer Inc. (through its partnership arrangements)
- Jiangsu Hengrui Medicine Co., Ltd.
- Piramal Critical Care, Inc.
Additionally, specialized chemical manufacturers produce intermediate chemicals that are further refined into Desflurane.
Leading Suppliers and Manufacturers
AbbVie Inc.
AbbVie remains the primary supplier of Desflurane globally. Its product, Suprane, is widely distributed across North America, Europe, and parts of Asia. The company's manufacturing facilities comply with stringent regulatory standards, ensuring high-purity product supply.
Maruishi Pharmaceutical Co., Ltd.
Japanese-based Maruishi is a significant regional supplier, predominantly serving the Asian market. Its Desflurane formulations meet Japanese Pharmacopoeia standards and are exported regionally.
Jiangsu Hengrui Medicine Co., Ltd.
This Chinese pharmaceutical firm has expanded its portfolio to include volatile anesthetics, including Desflurane. Hengrui’s competitive pricing and extensive regional presence make it a notable supplier in Asia.
Piramal Critical Care
Piramal manufactures and markets a range of anesthetic agents, with Desflurane being a key product in their portfolio. Their focus on advanced manufacturing processes allows consistency in supply quality.
Other Notable Chemical Suppliers
Apart from pharmaceutical firms, chemical manufacturers such as Merck KGaA and Synergetic Chemical produce the requisite high-purity chemicals and solvents used in Desflurane synthesis.
Regional Distribution and Market Dynamics
North America
The US market is predominantly supplied by AbbVie, with regulatory approval from the Food and Drug Administration (FDA). Suppliers here benefit from established distribution networks and strict quality control standards.
Europe
European markets primarily rely on AbbVie and other regional players. The European Medicines Agency (EMA) mandates compliance with EU regulations, which influence supplier choices.
Asia-Pacific
Asia features a more diverse supplier landscape, with significant contributions from Maruishi, Jiangsu Hengrui, and local distributors emphasizing affordability and regional manufacturing capacity. Chinese manufacturers are increasingly gaining market share owing to cost advantages and expanding production capabilities.
Regulatory and Quality Considerations
As a controlled substance, Desflurane’s supply chain is heavily regulated. Suppliers must acquire and maintain licenses from agencies like the FDA, EMA, and respective national authorities. Adherence to GMP ensures product safety, efficacy, and consistency.
Certification of manufacturing facilities, validated sourcing of chemical precursors, and rigorous quality testing are prerequisites for supplier credibility. Recent trends indicate increasing scrutiny of supply chains, especially in light of global crises impacting pharmaceutical manufacturing.
Supply Chain Challenges and Trends
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Regulatory Standoff and Licensing: Suppliers need ongoing regulatory approvals, which can delay production in response to policy shifts.
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Pricing Pressures: Geographic market competition drives pricing dynamics, affecting profitability and supplier margins.
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Manufacturing Consolidation: A trend toward consolidation among pharmaceutical manufacturers adds complexity but can improve supply chain resilience.
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Global Supply Disruptions: The COVID-19 pandemic highlighted vulnerabilities, prompting companies to diversify sourcing and bolster inventories.
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Environmental and Safety Regulations: Evolving standards concerning ozone depletion potential and global warming influence chemical manufacturing practices.
Future Outlook
The demand for Desflurane is expected to grow in tandem with rising global surgical volumes. However, competition from alternative anesthetics like Sevoflurane and Isoflurane, along with emerging anesthetic modalities, could influence demand dynamics.
Manufacturers focusing on sustainable production, regulatory compliance, and regional market expansion will shape the supply landscape. Innovations in chemical synthesis and packaging may also improve supply chain efficiency and product stability.
Key Takeaways
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Dominant Suppliers: AbbVie leads the market globally, with regional players such as Maruishi and Jiangsu Hengrui filling local needs.
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Regulatory Compliance: Strict adherence to GMP and licensing standards is essential for supplier credibility and market access.
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Regional Variance: North America and Europe predominantly rely on established multinational companies, while Asia exhibits a diverse supplier base with growing regional manufacturing capacity.
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Supply Chain Risks: Disruptions due to regulatory changes, geopolitical factors, and global crises necessitate strategic sourcing and inventory management.
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Market Opportunities: Opportunities exist for new entrants focusing on sustainably produced Desflurane or regional manufacturing to capture emerging markets.
FAQs
1. Who are the main global suppliers of Desflurane?
AbbVie Inc. is the primary global supplier, with regional manufacturers like Maruishi (Japan), Jiangsu Hengrui (China), and Piramal Critical Care (India) also active in the market.
2. What regulatory standards do Desflurane suppliers need to meet?
Suppliers must comply with GMP, obtain necessary health authority licenses (FDA, EMA, local agencies), and adhere to controls related to controlled substances classification.
3. Are there regional differences in Desflurane sourcing?
Yes. North America and Europe rely on established multinational suppliers, while Asia sources from regional manufacturers, often offering lower prices and shorter supply chains.
4. How might supply chain disruptions affect Desflurane availability?
Disruptions can stem from regulatory changes, manufacturing delays, or geopolitical issues, potentially causing shortages or price volatility.
5. What trends are influencing the future of Desflurane supply?
Increased adherence to environmental standards, supply chain resilience strategies, and regional manufacturing expansion are key trends shaping the market outlook.
References
[1] Pharmaceutical supplier focus and market reports.
[2] Regulatory guidelines for anesthetic agents.
[3] Global market analyses on inhalational anesthetics.
[4] Company websites and corporate disclosures.
[5] Industry publications on pharmaceutical manufacturing and supply chain dynamics.
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