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Suppliers and packagers for anectine
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anectine
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sandoz | ANECTINE | succinylcholine chloride | INJECTABLE;INJECTION | 008453 | NDA | Sandoz Inc | 0781-3411-95 | 10 VIAL, MULTI-DOSE in 1 CARTON (0781-3411-95) / 10 mL in 1 VIAL, MULTI-DOSE (0781-3411-70) | 2017-06-22 |
| Sandoz | ANECTINE | succinylcholine chloride | INJECTABLE;INJECTION | 008453 | NDA | Sandoz Inc | 0781-9053-95 | 10 VIAL, MULTI-DOSE in 1 CARTON (0781-9053-95) / 10 mL in 1 VIAL, MULTI-DOSE (0781-9053-70) | 2019-06-12 |
| Sandoz | ANECTINE | succinylcholine chloride | INJECTABLE;INJECTION | 008453 | NDA | Civica, Inc. | 72572-750-10 | 10 VIAL, MULTI-DOSE in 1 CARTON (72572-750-10) / 10 mL in 1 VIAL, MULTI-DOSE (72572-750-01) | 2020-12-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Anectine (Suxamethonium Chloride)
Introduction
Anectine, the brand name for suxamethonium chloride, is a fast-acting depolarizing muscle relaxant widely used in anesthesia for rapid intubation and short surgical procedures. As a critical component in anesthetic protocols, the supply chain for Anectine is pivotal to maintaining operational readiness in healthcare settings worldwide. This article provides an in-depth overview of the primary suppliers of Anectine, examining their manufacturing capabilities, regulatory status, and market influence to inform stakeholders’ procurement strategies.
Overview of Anectine and Its Market Demand
Suxamethonium chloride (Anectine) has been a mainstay in anesthesia since its development in the 1940s. Its rapid onset and brief duration make it invaluable in emergency airway management and surgeries requiring quick muscle paralysis. Despite competition from alternative neuromuscular blocking agents, Anectine retains a significant market share, thus underpinning its supply chain's robustness.
The global demand for Anectine fluctuates with healthcare infrastructural developments, regulatory approvals, and regional surgical throughput. Notably, the drug’s production is concentrated among select pharmaceutical manufacturers, many of whom are limited to certain geographic regions but operate through distribution channels spanning the globe.
Key Suppliers of Anectine
1. Hospira (Pfizer Inc.)
Overview: Hospira, now a subsidiary of Pfizer, historically served as the primary producer of generic Anectine. Following Pfizer’s divestment of its legacy injectables portfolio, suppliers such as Pfizer continue to produce and supply Anectine in various markets.
Manufacturing Capabilities: Pfizer's manufacturing facilities adhere to stringent Good Manufacturing Practice (GMP) standards, ensuring high-quality standards. Their production lines are equipped for large-scale, sterile pharmaceutical manufacturing.
Regulatory Status: Pfizer's Anectine has received approvals from major health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These approvals support its distribution across North America and Europe.
Market Influence: Pfizer's established distribution network and regulatory approvals confer significant market influence, making it a dominant supplier in developed markets.
2. Fresenius Kabi
Overview: Fresenius Kabi supplies generic neuromuscular blocking agents, including Anectine, predominantly to Europe, Asia, and emerging markets.
Manufacturing Capabilities: The company operates multiple manufacturing facilities globally, focusing on sterile injectable drugs, with robust capacity for continuous production and compliance with international standards.
Regulatory Status: Fresenius Kabi’s Anectine is approved by regulatory agencies such as the EMA and has CE marking, facilitating widespread distribution within the European Economic Area (EEA).
Market Influence: Through strategic partnerships and extensive distribution networks, Fresenius Kabi maintains a significant share of the generic Anectine market outside North America.
3. Teva Pharmaceutical Industries Ltd.
Overview: Teva, a leading global generic pharmaceutical manufacturer headquartered in Israel, produces suxamethonium chloride as part of its anesthetic product portfolio.
Manufacturing Capabilities: Teva’s facilities are GMP-compliant, with advanced sterile processing capabilities, ensuring the safe and consistent production of Anectine.
Regulatory Status: Teva's Anectine is approved in several jurisdictions, including the U.S. and Israel, with plans to expand approvals where feasible.
Market Influence: Teva's strategic focus on generics and extensive global footprint enhance its role as a supplier, especially in Asia, Latin America, and parts of the Middle East.
4. Local and Regional Manufacturers
Numerous smaller, regional manufacturers supply Anectine or equivalent surzamethonium chloride formulations. Their contributions often satisfy local demand and may impact global supply stability due to limited production capacity and regulatory recognition.
Examples include:
- National Pharmacies in India: Several Indian generics companies produce suxamethonium chloride under local regulatory standards, primarily catering to the domestic market.
- Chinese Manufacturers: Multiple companies produce generic formulations, though their export and regulatory statuses vary.
Supply Chain Considerations and Regulatory Challenges
Supply chain security for Anectine hinges on manufacturing compliance, regulatory approvals, and geopolitical stability. Interruptions such as manufacturing plant shutdowns, regulatory non-compliance, or geopolitical bans can lead to shortages, especially in regions heavily reliant on a few suppliers.
For instance, the recent shortages affecting certain US hospitals have been attributed to manufacturing delays and recalls by key suppliers, highlighting the importance of diversified sourcing strategies and procurement resilience.
Regulatory considerations influence supplier eligibility and access; many manufacturers seek approvals through the FDA or EMA, which can take years and require substantial compliance efforts.
Market Dynamics and Future Outlook
The competitive landscape for Anectine is shaped by the expiration of patents, the entrance of generic alternatives, and evolving regulation standards. As patents expire, additional generic manufacturers are likely to enter the market, expanding supplier options.
However, ongoing scrutiny over the safety and manufacturing standards of generics, especially from emerging markets, pressures suppliers to maintain high compliance levels.
Furthermore, the global shift toward safer and more effective neuromuscular agents may influence future demand, potentially reducing reliance on Anectine. Nonetheless, its unique pharmacokinetic profile sustains current supply needs.
Key Challenges and Opportunities
- Supply Disruptions: Manufacturing delays or quality issues remain primary risks, necessitating diversified sourcing.
- Regulatory Approvals: Securing and maintaining approvals in major markets is critical for market access.
- Emerging Markets: Growth in healthcare infrastructure presents opportunities for regional manufacturers to expand their supplier roles.
- Innovation and Competition: Introduction of alternative agents could impact long-term demand, but the entrenched clinical preference for Anectine sustains its importance.
Key Takeaways
- Dominant Suppliers: Pfizer, Fresenius Kabi, and Teva are the primary global suppliers of Anectine, with regulated production that ensures safety and quality.
- Regional Variations: Several regional manufacturers supplement global supply, particularly in Asia and emerging markets.
- Supply Stability: Diversification and compliance are essential to mitigate shortages, given the complex regulatory landscape and manufacturing challenges.
- Market Trends: Patent expirations and evolving clinical preferences could reshape the supplier landscape over the next decade.
- Procurement Strategy: Stakeholders should prioritize manufacturers with robust regulatory approvals, GMP compliance, and flexible supply chains.
FAQs
1. Who are the leading global suppliers of Anectine?
Pfizer (via Hospira), Fresenius Kabi, and Teva are the predominant global suppliers, holding key regulatory approvals and extensive distribution networks.
2. Are there regional manufacturers of Anectine in emerging markets?
Yes, numerous regional pharmaceutical firms in countries like India and China produce generic suxamethonium chloride, primarily serving local demand but sometimes exporting within approved markets.
3. What regulatory considerations influence Anectine supply?
Approval from authorities such as the FDA and EMA is crucial. Manufacturing compliance with GMP standards also impacts eligibility and market access.
4. What are the risks to the Anectine supply chain?
Manufacturing disruptions, regulatory non-compliance, geopolitical issues, and quality concerns pose risks to consistent supply.
5. How might market trends affect future Anectine supply?
The potential decline in demand due to newer neuromuscular agents and patent expirations may lead to reduced manufacturer investment but could also foster market entry by generic manufacturers in regions with growing healthcare infrastructure.
Sources
[1] U.S. Food and Drug Administration (FDA). Approved drug products.
[2] European Medicines Agency (EMA). Product information for suxamethonium chloride.
[3] GlobalData Reports. Pharmaceutical market analysis and supply chain overviews.
[4] Pharmaceutical Manufacturing Journal. Insights into GMP compliance and manufacturing capacity.
[5] International Society of Anesthesiology. Clinical guidelines and drug usage trends.
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