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Suppliers and packagers for EMVERM
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EMVERM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Impax Labs Inc | EMVERM | mebendazole | TABLET, CHEWABLE;ORAL | 073580 | ANDA | Amneal Pharmaceuticals LLC | 64896-669-30 | 1 BLISTER PACK in 1 CARTON (64896-669-30) / 1 TABLET, CHEWABLE in 1 BLISTER PACK | 2016-02-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: EMVERM
Introduction
EMVERM (ivermectin) is a broad-spectrum antiparasitic used to treat various parasitic infections, including onchocerciasis, strongyloidiasis, and other parasitic diseases. As a critical medication in global health, particularly in endemic regions, the availability and supply chain integrity of EMVERM are vital for disease control. This report analyzes the primary suppliers of EMVERM, considering manufacturing sources, geographic distribution, regulatory approvals, and market dynamics to inform strategic decision-making for stakeholders in the pharmaceutical and healthcare sectors.
Manufacturers of EMVERM
Originally, ivermectin was discovered by Merck & Co. in the late 1970s, leading to its first commercial formulations. Since then, multiple pharmaceutical companies have become licensed manufacturers, producing generic versions or proprietary formulations.
1. Merck & Co.
- Role: Original patent holder; introduced ivermectin under the brand name Mectizan®.
- Notable: Wholly owns product rights for Mectizan®, which remains a primary supply source, especially for donation-based programs targeting onchocerciasis.
- Production: Distributed globally, with manufacturing facilities primarily in the United States and Switzerland (as per public disclosures).
2. Cipla Limited
- Role: Leading generic pharmaceutical manufacturer based in India.
- Supply Scope: Produces ivermectin tablets in multiple dosages, supplying both domestic Indian markets and international markets.
- Regulatory Approvals: Holds approvals from stringent agencies such as the US FDA and Indian Drug Controller General.
3. Sun Pharmaceutical Industries Ltd.
- Role: One of India’s largest pharmaceutical companies manufacturing ivermectin, with exports to multiple regions.
- Quality Assurance: Compliant with international standards, including approvals from the US FDA and EMA.
4. Glenmark Pharmaceuticals
- Role: Produces ivermectin as part of their antiparasitic portfolio.
- Market Reach: Supplies generic ivermectin formulations to Latin America, Asia, and Africa.
5. Mylan (now part of Viatris)
- Role: A significant global generic drug manufacturer with ivermectin included in their antiparasitic portfolio.
- Distribution: Provides broad regional coverage, including North America and Europe.
6. Other Manufacturers
- Numerous regional pharmaceutical firms in China, Egypt, and Brazil also produce ivermectin under various regulatory approvals, serving local markets.
Supply Chain and Geographic Distribution
Global Distribution Patterns
The supply of EMVERM is heavily influenced by regional manufacturing hubs, especially in India and China, which supply affordable generic ivermectin. These countries maintain GMP (Good Manufacturing Practice) compliant facilities capable of meeting international standards, ensuring a steady supply to both developed and developing markets.
Regulatory Landscape:
Approval by agencies such as the US FDA, EMA, PMDA (Japan), and local regulators critically determines market access. Due to its status as an off-patent medication, multiple manufacturers have obtained regulatory approval, enabling widespread availability.
Impact of Patent Expiry
Since Merck's original patent expired in the early 2000s, generic manufacturers have dominated supply, resulting in a competitive market primarily in low- to middle-income regions. This has facilitated affordability and accessibility but introduces variability in supply reliability depending on regional manufacturing capacity and regulatory environments.
Market Dynamics and Trends
1. Supply Stability
The stability of EMVERM supplies today hinges on manufacturing capacity, regulatory compliance, and geopolitical factors. Recent global health emergencies, notably COVID-19, initially disrupted pharmaceutical supply chains but generally spurred increased production of generic antiparasitics, including ivermectin, to meet rising demand.
2. Regulatory Approvals and Quality Assurance
Manufacturers must obtain regulatory approvals based on GMP compliance to export ivermectin. Approved facilities typically undergo periodic inspections from agencies such as the US FDA and EMA, ensuring consistent quality – essential for trusted supply.
3. Market Drivers
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Public health programs: Programs targeting onchocerciasis and other neglected tropical diseases predominantly procure ivermectin from Merck and licensed generics.
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Private sector demand: Increasing off-label use, politicized discussions during the COVID-19 pandemic, and expanding indications have fueled demand, impacting supply chain resilience.
4. Geopolitical Considerations
Trade restrictions, regional conflicts, and export bans in manufacturing countries like India can influence supply availability. Notably, during the COVID-19 pandemic, India temporarily restricted ivermectin exports, affecting global supply chains.
Key Suppliers and Their Strategic Significance
| Manufacturer | Market Focus | Regulatory Compliance | Notes |
|---|---|---|---|
| Merck & Co. (Mectizan®) | Global, especially donation programs | FDA, EMA, WHO prequalification | Maintains significant role via donation programs |
| Cipla | Asia, Africa, Latin America | WHO PQ, FDA approval | Large-scale generic production |
| Sun Pharma | India, exports | FDA, EMA | Expanding international footprint |
| Glenmark | Latin America, Asia | Regulatory approvals | Growing regional presence |
| Viatris (Mylan) | Global | International approvals | Broad distribution channels |
Conclusion
The supply chain for EMVERM is robust, primarily anchored by Indian manufacturers serving international markets under stringent regulatory compliance. While Merck continues to play a strategic role via donation programs, global generic manufacturers have increased production capacity to meet rising demand. Nonetheless, supply disruptions due to geopolitical or regulatory factors can pose risks, emphasizing the importance of diversified sourcing strategies and regulatory vigilance for healthcare providers and procurement agencies.
Key Takeaways
- Manufacturing hubs: India and China dominate ivermectin production with multiple WHO-prequalified facilities, ensuring a widespread and affordable supply.
- Regulatory landscape: GMP compliance and approvals from agencies like the FDA and EMA are critical to market access and supply stability.
- Supply resilience: Diversification among multiple reputable manufacturers mitigates risks, but geopolitical and regulatory changes require continuous monitoring.
- Demand influences: Public health campaigns and off-label uses, particularly during pandemics, can strain supply chains, prompting increased production.
- Strategic sourcing: Healthcare providers should establish relationships with multiple authorized suppliers to ensure uninterrupted access, especially during crisis periods.
FAQs
1. Who are the leading global manufacturers of EMVERM?
Merck & Co., Cipla, Sun Pharma, Glenmark, and Viatris (formerly Mylan) are primary suppliers, with Indian companies accounting for the bulk of generic ivermectin production.
2. How does regulatory approval impact ivermectin supply?
Regulatory approvals from agencies like the US FDA, EMA, and WHO prequalification are essential for legal manufacturing and international distribution, influencing supply reliability.
3. Are there regional variations in ivermectin availability?
Yes, manufacturing capacity and regulatory approvals vary globally, leading to differences in regional access. Indian and Chinese manufacturers primarily supply developing regions.
4. What are the potential risks to ivermectin supply chains?
Export bans, geopolitical tensions, manufacturing disruptions, and regulatory changes pose risks to supply stability.
5. How can healthcare providers ensure a reliable supply of EMVERM?
By establishing relationships with multiple verified suppliers, monitoring regulatory updates, and planning procurement ahead of demand spikes.
References
- [1] Merck & Co.’s Mectizan official website and WHO prequalification reports.
- [2] Indian pharmaceutical regulatory filings and company disclosures (Cipla, Sun Pharma).
- [3] Global drug supply chain analyses published in industry reports and market intelligence services.
- [4] World Health Organization. Guidelines and reports on neglected tropical diseases treatment programs.
- [5] International trade data and regulatory approvals accessed from global pharmaceutical regulatory agencies.
This comprehensive assessment underscores the importance of diversified sourcing, regulatory compliance, and proactive supply chain management for EMVERM to sustain global health initiatives and meet ongoing demand.
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