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Suppliers and packagers for generic pharmaceutical drug: ivermectin
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ivermectin
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Padagis Israel | IVERMECTIN | ivermectin | CREAM;TOPICAL | 210225 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-102-84 | 1 TUBE in 1 CARTON (45802-102-84) / 45 g in 1 TUBE | 2024-01-08 |
| Padagis Israel | IVERMECTIN | ivermectin | CREAM;TOPICAL | 210225 | ANDA | Bryant Ranch Prepack | 71335-2946-1 | 1 TUBE in 1 CARTON (71335-2946-1) / 45 g in 1 TUBE | 2024-01-08 |
| Padagis Israel | IVERMECTIN | ivermectin | CREAM;TOPICAL | 210225 | ANDA | Bryant Ranch Prepack | 72162-2294-2 | 1 TUBE in 1 CARTON (72162-2294-2) / 45 g in 1 TUBE | 2024-01-08 |
| Teva Pharms Usa | IVERMECTIN | ivermectin | CREAM;TOPICAL | 210019 | ANDA | Actavis Pharma, Inc. | 0591-4052-89 | 1 TUBE in 1 CARTON (0591-4052-89) / 45 g in 1 TUBE | 2019-10-14 |
| Teva Pharms Usa | IVERMECTIN | ivermectin | CREAM;TOPICAL | 210019 | ANDA | Bryant Ranch Prepack | 63629-8754-1 | 1 TUBE in 1 CARTON (63629-8754-1) / 45 g in 1 TUBE | 2019-10-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ivermectin
Introduction
Ivermectin, a broad-spectrum antiparasitic agent, has garnered significant attention beyond its primary indications for managing certain parasitic infections. Its emergent off-label applications and potential for new therapeutic uses have heightened demand globally. Consequently, understanding the landscape of key suppliers is vital for stakeholders—including healthcare providers, pharmaceutical companies, and investors—seeking reliable procurement channels and market intelligence on ivermectin.
Overview of Ivermectin as a Pharmaceutical Product
Originally developed in the 1970s and widely commercialized over the following decades, ivermectin was awarded the Nobel Prize in Physiology or Medicine in 2015. Its foremost approved indications include onchocerciasis and lymphatic filariasis, managed predominantly through mass drug administration (MDA) programs by organizations such as the World Health Organization (WHO).
Recent developments—particularly during the COVID-19 pandemic—have propelled ivermectin into the spotlight as a candidate for repurposing, despite ongoing debates about efficacy and safety. This surge in demand has influenced supply dynamics, emphasizing the importance of multiple reputable suppliers capable of meeting increased global requirements.
Key Global Suppliers of Ivermectin
1. Merck & Co., Inc. (MSD)
- Market Role: The original developer of ivermectin, Merck exclusively licenses the drug for human use.
- Supply and Distribution: Merck manufactures and supplies ivermectin under the brand name Stromectol. The company also actively participates in global health initiatives, supplying ivermectin for neglected tropical diseases (NTDs) through donations and partnerships.
- Significance: As the patent holder and primary manufacturer, Merck remains a dominant supplier, especially in countries with established procurement contracts.
2. Cipla Limited
- Market Role: A leading Indian pharmaceutical manufacturer with significant production capacities for ivermectin.
- Supply Scope: Cipla produces both generic ivermectin tablets (e.g., 3 mg, 6 mg), catering to domestic and international markets, including Africa, Asia, and Latin America.
- Quality Assurance: Cipla complies with WHO-GMP standards and provides products approved by national regulators such as the US FDA, European EMA, and other stringent agencies.
3. Sun Pharmaceutical Industries Ltd.
- Market Role: An Indian multinational with an extensive portfolio of antiparasitic medications.
- Supply Capabilities: Offers generic formulations of ivermectin, with a widespread distribution network in emerging markets.
- Regulatory Status: Many formulations are approved by major agencies, allowing broad distribution.
4. Mylan N.V. (Now part of Viatris Inc.)
- Market Role: A significant player in the global generics market.
- Product Portfolio: Supplies ivermectin through various formulations, often in combination with other antiparasitic agents.
- Global Reach: Distributes to multiple markets, including North America, Europe, and developing nations.
5. Goldline Pharmaceuticals
- Regional Focus: Predominantly supplies in African, Middle Eastern, and South Asian markets.
- Market Position: Known for low-cost generic ivermectin formulations, often used in large-scale NTD programs.
6. Other Notable Suppliers
- Aurobindo Pharma, *Casion Pharma, and Teva Pharmaceutical Industries** also produce generic ivermectin formulations, expanding supply options across different geographic regions.
Manufacturing and Quality Standards
Given ivermectin's widespread use in public health campaigns, manufacturers adhere to international quality standards, including Good Manufacturing Practices (GMP). Regulatory approval from agencies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and WHO prequalification enhances supplier credibility and mitigates risks of substandard products.
Emerging markets often rely on multiple sources, but global procurement increasingly emphasizes suppliers with verified compliance to international standards to assure safety and efficacy.
Supply Chain Considerations
The supply chain of ivermectin faces several challenges:
- Raw Material Availability: Formulation heavily depends on the active pharmaceutical ingredient (API). Fluctuations in API production capacity can impact overall supply.
- Regulatory Approvals: Variations in approval status across countries may influence procurement choices.
- Market Demand: The COVID-19 resurgence raised demand unexpectedly, leading to shortages and quality concerns.
- Geopolitical Factors: Export bans, import restrictions, and trade regulations can disrupt procurement channels.
To mitigate these issues, organizations often source from multiple suppliers and maintain buffer stocks, emphasizing the importance of diversified sourcing strategies.
Emerging Trends and Market Dynamics
- Increased Production: Several Indian API manufacturers have expanded capacity for ivermectin synthesis, responding to global demand.
- Generic Dominance: The market is predominantly driven by generic formulations, offering cost-effective options.
- Licensing & Partnerships: Patent expirations and licensing agreements facilitate broader manufacturing and distribution.
Regulatory and Ethical Considerations
- Quality Assurance: Procurement from certified suppliers adhering to WHO prequalification is critical to prevent substandard or falsified medicines.
- Intellectual Property: Limited patent protections enable multiple manufacturers to produce ivermectin generics.
- Public Health Policy: Governments and international organizations prioritize sourcing from reliable suppliers to ensure supply continuity during health crises.
Conclusion
Identifying reliable ivermectin suppliers necessitates evaluating manufacturing capacity, adherence to regulatory standards, and geopolitical stability. Leading multinational companies like Merck & Co. (via licensing) and prominent Indian generics manufacturers—such as Cipla, Sun, and Aurobindo—are pivotal players. Market dynamics continue to evolve, driven by global health needs and regulatory landscapes.
Key Takeaways
- Diverse Supply Sources: Reliance on multiple trusted manufacturers—both originators and generics—enhances supply security.
- Regulatory Compliance: Prioritize suppliers with WHO prequalification and approvals from major agencies.
- Market Trends: The expansion of Indian API manufacturers has increased global ivermectin supply capacity.
- Supply Chain Risks: Raw material availability, regulatory hurdles, and geopolitical factors influence procurement strategies.
- Public Health Focus: Ensuring quality and safety remains paramount in sourcing ivermectin, especially amid increased demand scenarios.
FAQs
1. Who are the leading global manufacturers of ivermectin?
Major suppliers include Merck & Co. (via licensing for human formulations), Indian pharmaceutical companies like Cipla, Sun Pharma, and Aurobindo Pharma, along with other generics manufacturers such as Mylan and Teva. These companies provide a broad range of formulations for international markets.
2. Are ivermectin formulations approved by major regulatory agencies?
Yes. While some formulations are approved by agencies like the US FDA and EMA, others comply with WHO prequalification standards. It’s essential for procurers to verify regulatory status based on their target markets.
3. How has the COVID-19 pandemic affected ivermectin supply?
Demand surged internationally as some advocacy groups promoted ivermectin for COVID-19, leading to supply shortages and quality concerns. This situation prompted increased production efforts by Indian API manufacturers and prompted regulatory scrutiny.
4. What should organizations consider when sourcing ivermectin?
Prioritize suppliers with proven regulatory compliance, high manufacturing standards, and stable supply histories. Diversifying suppliers reduces dependency on single sources and mitigates risks.
5. What are future market trends for ivermectin suppliers?
The market is expected to stabilize as production capacities expand, with ongoing regulatory evaluations influencing demand. The focus on quality assurance and international cooperation will remain critical in maintaining supply chains.
References
- World Health Organization. Prequalification of Medicinal Products. https://www.who.int/medicines/regulation/prequalification
- Merck & Co. Official Website. Stromectol Product Information.
- Indian Pharmaceutical Association. Indian Generic Market Report. (2022)
- US FDA. Drug Approvals and Regulatory Information.
- Studies on ivermectin production capacity and market trends (2022).
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