Suppliers and packagers for edluar
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edluar
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Viatris | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997 | NDA | Viatris Specialty LLC | 0037-6010-93 | 5 BLISTER PACK in 1 CARTON (0037-6010-93) / 6 TABLET in 1 BLISTER PACK (0037-6010-35) | 2009-07-24 |
| Viatris | EDLUAR | zolpidem tartrate | TABLET;SUBLINGUAL | 021997 | NDA | Viatris Specialty LLC | 0037-6050-93 | 5 BLISTER PACK in 1 CARTON (0037-6050-93) / 6 TABLET in 1 BLISTER PACK (0037-6050-35) | 2009-07-24 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Edluar
Introduction
Edluar, a brand name for the medication containing zolpidem tartrate, is a widely prescribed sleep aid belonging to the sedative-hypnotic class. Approved by regulatory agencies such as the U.S. Food and Drug Administration (FDA), Edluar is primarily used for short-term treatment of insomnia. As a popular sleep aid, the demand for Edluar influences global supplier networks. This report provides a comprehensive overview of the key suppliers involved in the manufacturing, distribution, and distribution of Edluar, focusing on their roles, geographic locations, and market influence.
Understanding Edluar and Its Manufacturing Process
Edluar’s active pharmaceutical ingredient (API), zolpidem tartrate, is synthesized through advanced chemical processes requiring specialized facilities that meet Good Manufacturing Practice (GMP) standards. The compounding of the drug into sublingual tablets ensures rapid absorption, catering to acute sleep disturbances. Given its clinical importance, the supply chain comprises API producers, formulation specialists, and packaging entities.
Major API Suppliers for Edluar
1. Domestic Pharmaceutical Manufacturers
Several pharmaceutical giants in the United States and Europe manufacture and supply the API directly or through licensed partnerships. These include:
- Takeda Pharmaceuticals: As the original developer of Edluar, Takeda maintains a vertically integrated supply chain that covers API production and final formulation. Their manufacturing plants, primarily in Japan and North America, ensure quality and supply stability.
- Mitsubishi Tanabe Pharma Corporation: Collaborating with Takeda, Mitsubishi provides API manufacturing capabilities, prioritizing consistency and compliance with international standards.
- Teva Pharmaceutical Industries: A global generic and branded drug manufacturer, Teva has the capacity to produce zolpidem tartrate API at scale, especially to meet global demand for sleep aids.
2. Contract Manufacturing Organizations (CMOs)
CMOs play a vital role in supplementing in-house production, often providing API synthesis or formulation services:
- Hikal Ltd. (India): Known for custom synthesis of APIs, Hikal supplies zolpidem tartrate to various pharmaceutical companies worldwide, emphasizing cost-efficiency and regulatory compliance.
- Siegfried AG (Switzerland): Provides development, manufacturing, and purification services for APIs, including compounds like zolpidem tartrate.
3. Asian API Producers
The global API market significantly depends on Asian manufacturers due to cost advantages and manufacturing capacity:
- Shanghai-based Yangtze River Pharmaceutical Group: Engaged in API production, including sedatives, with extensive export capabilities.
- Hanmi Pharmaceutical (South Korea): A research-driven firm with API manufacturing experience, supplying both domestic and international markets.
Distribution and Supply Chain Dynamics
1. Original Equipment Manufacturers (OEMs)
Original producers such as Takeda and Mitsubishi coordinate the entire supply process from API synthesis to critical documentation and quality assessments to ensure regulatory authorities’ approvals are maintained across jurisdictions.
2. Generic and Brand Market Distribution
Once approved, Edluar became available as a generic product, with other companies authorized under licensing agreements or through authorized generics. These companies source API from primary suppliers or CMOs. Their distribution networks span multiple geographies, including North America, Europe, and emerging markets in Asia and Latin America.
3. Regulatory Considerations
Regulatory authorities such as the U.S. FDA, EMA, and others impose strict standards on API manufacturing and distribution. Suppliers must demonstrate compliance with GMP, batch consistency, purity standards, and robust quality control measures. Regulatory approvals influence supply chain stability and market access.
Key Suppliers and Their Strategic Positions
| Supplier | Role | Location | Market Influence | Notes |
|---|---|---|---|---|
| Takeda Pharmaceuticals | Original API producer | Japan | High | Maintains strategic control over Edluar API supply; ensures quality adherence |
| Mitsubishi Tanabe Pharma | API manufacturing partner | Japan | High | Critical in fulfilling global supply demands |
| Teva Pharmaceutical Industries | API supplier and generic manufacturer | Israel | Major | Supplies to global markets; scaling capacity based on demand |
| Hikal Ltd. | Contract manufacturer | India | Growing | Cost-effective API supplies; expanding manufacturing capacity |
| Yangtze River Pharmaceutical Group | API producer | China | Significant | Competitive pricing; large export operations |
Future Outlook for Edluar Suppliers
The global sleep aid market faces evolving regulatory environments, rising competition from newer pharmacological agents, and increased demand for generics. Key suppliers are investing in capacity expansion, technological innovation, and quality improvements to sustain their market position. Supply chain resilience is gaining focus, especially amid geopolitical tensions and disruptions caused by the pandemic.
Conclusion
The supply of Edluar hinges on a network of dedicated API producers, formulation specialists, and distributors. Original manufacturers like Takeda and Mitsubishi play central roles, complemented by competitive Asian API suppliers such as Hikal and Yangtze River Pharmaceutical. Ensuring regulatory compliance, scaling production, and maintaining quality standards are critical to supply chain stability. As the demand for sleeping aids grows globally, these suppliers' strategic positioning will significantly influence Edluar’s availability and market competitiveness.
Key Takeaways
- Edluar's supply chain relies heavily on both original and contract manufacturers, emphasizing quality, compliance, and capacity.
- Takeda and Mitsubishi are primary API sources, owing to their direct involvement in Edluar’s development and manufacturing.
- Asian API producers, notably China and India, provide cost-effective production options, increasingly essential for global supply coverage.
- Regulatory adherence remains a critical factor influencing supplier credibility and distribution rights worldwide.
- Ongoing capacity expansion and technological advancements by suppliers will shape the future stability and accessibility of Edluar.
Frequently Asked Questions (FAQs)
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