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Suppliers and packagers for elimite
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elimite
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Usa | ELIMITE | permethrin | CREAM;TOPICAL | 019855 | NDA | Aurobindo Pharma Limited | 59651-834-60 | 1 TUBE in 1 CARTON (59651-834-60) / 60 g in 1 TUBE | 2024-01-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: ELIMITE
Introduction
ELIMITE, a topical medication primarily containing permethrin as its active ingredient, is widely prescribed for the treatment of scabies and lice infestations. As a prescription medication, its supply chain encompasses a diverse array of manufacturers, distributors, and licensed pharmacies worldwide. This article provides an in-depth analysis of key suppliers for ELIMITE, exploring the landscape of authorized manufacturers, distribution channels, and market Avenues, with implications for industry stakeholders seeking reliable supply sources.
Overview of ELIMITE and Market Significance
ELIMITE (permethrin) is a well-established antiparasitic agent, with a history spanning several decades [1]. Its efficacy, safety profile, and ease of topical application have cemented its position in dermatological therapeutics. Market demand persists due to ongoing incidences of scabies and pediculosis, ensuring a steady need for quality supply sources.
Key Suppliers and Manufacturers of ELIMITE
1. Valeant Pharmaceuticals International (Part of Bausch Health Companies)
Historically, Valeant was the primary manufacturer of ELIMITE in North America, offering both 5% permethrin cream and other formulations. The company’s manufacturing facilities adhere to stringent FDA standards, ensuring compliance and quality. Recent restructuring has affected supply channels, prompting stakeholders to monitor ongoing production viability [2].
2. Glenmark Pharmaceuticals
Glenmark is a leading Indian pharmaceutical company that manufactures permethrin-based products, including ELIMITE or equivalent formulations marketed under different brand names. Its global manufacturing footprint and adherence to international quality standards position it as a significant supplier in emerging markets [3].
3. Teva Pharmaceutical Industries
Teva supplies permethrin-based products in various regions, often through licensing agreements or generic formulations. While not exclusively manufacturing ELIMITE, their portfolio includes permethrin topical creams and lotions, often equivalent to branded products at lower costs. Their extensive distribution network makes them a critical supplier for markets seeking affordable options [4].
4. Mylan (a subsidiary of Viatris)
Mylan, now part of Viatris, produces generic dermatological formulations, including permethrin creams. Their global manufacturing sites in the United States and India ensure consistent supply and adherence to regulatory standards, making them a reliable source in multiple markets [5].
5. Localized and Regional Manufacturers
Numerous regional pharmaceutical firms in Europe, Asia, and Latin America manufacture permethrin-based agents. These companies often produce generic variants conforming to local regulatory standards, contributing substantially to localized supply chains. Notable examples include Famar in Greece and Kinex Pharmaceuticals in India [6].
Regulatory and Patent Considerations
Originally branded as ELIMITE by Valeant, the patent protection for permethrin formulations has long expired, enabling generic manufacturers to produce equivalent products. This has led to increased competition and diversified suppliers worldwide. Regulatory approval processes differ among countries, impacting supplier credibility and availability.
Distribution Channels and Supply Chain Dynamics
The supply of ELIMITE primarily involves licensed pharmaceutical wholesalers, hospital procurement, and retail pharmacy chains. Distributors with regional licenses often source from licensed manufacturers like Glenmark or Viatris. Supply chain disruptions have occasionally occurred due to manufacturing delays, regulatory changes, or raw material shortages, underscoring the importance of identifying multiple reliable suppliers.
Market Trends and Emerging Suppliers
- Genericization and Market Entry: The expiration of patents has facilitated a surge in generic permethrin products, expanding the supplier base [7].
- Manufacturing Innovations: Companies investing in scalable, compliant manufacturing facilities have increased supply stability.
- E-commerce and Online Pharmacies: Growing reliance on online platforms has expanded access to permethrin products from authorized regional suppliers, though regulatory oversight remains crucial.
Implications for Stakeholders
- Healthcare Providers: Need to verify product authenticity and supplier reliability, especially given proliferation of generic options.
- Pharmaceutical Distributors: Should establish relationships with reputable manufacturers such as Mylan, Teva, and regional producers to mitigate supply risks.
- Regulatory Agencies: Must monitor market entries and verify compliance to ensure patient safety.
- Investors and Business Professionals: Opportunities lie in partnering with or investing in regional manufacturing hubs with capacity to meet local and global demand.
Conclusion
The supply landscape for ELIMITE (permethrin) is characterized by multiple key suppliers, including legacy manufacturers like Valeant, and numerous generic producers across Asia, India, and Europe. The expiration of patent protections has democratized supply, fostering competition but also emphasizing the importance of rigorous quality control. Stakeholders must navigate regional regulations, ensure product authenticity, and develop diversified sourcing strategies to sustain reliable access to this essential drug.
Key Takeaways
- Major suppliers include Valeant (Bausch Health), Glenmark, Teva, and Viatris (Mylan), alongside regional manufacturers.
- Generic proliferation has expanded supply options, but quality verification remains critical.
- Supply chain stability depends on diversified sourcing, regulatory compliance, and manufacturing capacity.
- Regional and emerging markets benefit from local producers, increasingly integral to local distribution.
- Stakeholders should prioritize establishing partnerships with reputable manufacturers to mitigate supply disruptions.
FAQs
Q1: Who are the leading global manufacturers of ELIMITE?
A1: The primary global manufacturers historically included Valeant (now Bausch Health), Glenmark, Teva, and Viatris (formerly Mylan). Numerous regional producers also manufacture permethrin formulations.
Q2: Can I find ELIMITE from generic suppliers?
A2: Yes. Patent expirations have enabled many generic manufacturers to produce permethrin creams, often at lower costs, provided they comply with regional regulatory standards.
Q3: Are regional suppliers reliable for ELIMITE?
A3: Reliability depends on regulatory compliance, manufacturing quality, and supply chain stability. Reputable regional producers in India, Europe, and Asia often meet international standards, but verification is essential.
Q4: How has patent expiration affected ELIMITE's supply landscape?
A4: Patent expiration has increased the number of manufacturers and supply sources, leading to greater competition and affordability but also amplifying the importance of quality control.
Q5: What are the risks associated with sourcing ELIMITE from multiple suppliers?
A5: Risks include variability in product quality, regulatory non-compliance, supply disruptions, and counterfeit products. Due diligence and ongoing quality assurance are vital.
Sources
[1] U.S. Food and Drug Administration (FDA). Permethrin Topical (Elimite).
[2] Bausch Health Annual Report. 2022.
[3] Glenmark Pharmaceuticals Official Website. Product Portfolio.
[4] Teva Pharmaceutical Industries. Permethrin Products Overview.
[5] Viatris (formerly Mylan). Product Portfolio.
[6] Regional pharmaceutical regulatory agencies.
[7] Market Analysis Reports on Permethrin and Generic Drugs, 2021-2023.
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