Suppliers and packagers for IMPAVIDO

IMPAVIDO

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Knight Theraps	IMPAVIDO	miltefosine	CAPSULE;ORAL	204684	NDA	Profounda, Inc.	69051-300-01	2 BLISTER PACK in 1 CARTON (69051-300-01) / 14 CAPSULE in 1 BLISTER PACK	2015-10-29

Suppliers for the Pharmaceutical Drug: IMPAVIDO (IVERMATIN)

Last updated: August 5, 2025

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Introduction

IMPAVIDO, the branded formulation of ivermectin, is an antiparasitic medication predominantly used in the treatment of diseases such as onchocerciasis (river blindness), strongyloidiasis, and other parasitic infections. The drug gained renewed interest amid emerging discussions around its potential use in combating various infectious diseases, although its primary indications remain parasitic conditions. Understanding the current landscape of suppliers for IMPAVIDO is critical for stakeholders including healthcare providers, pharmaceutical distributors, and policymakers looking to ensure drug availability and supply chain resilience.

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Overview of IMPAVIDO Manufacturing and Supply Chain

IMPAVIDO is marketed by Viamet Pharmaceuticals, which holds the patent rights for the drug's specific formulation. The production involves multiple stages including active pharmaceutical ingredient (API) synthesis, formulation, packaging, and distribution. The API, ivermectin, is also produced by various generic manufacturers, with some licensed to produce the branded IMPAVIDO formulation under licensing agreements.

The global supply network involves a combination of proprietary manufacturers and authorized generic producers operating across multiple regions. The supply chain's complexity underscores the importance of understanding who the key suppliers are to gauge availability, regional access, and price stability.

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Primary Suppliers of IMPAVIDO

1. Viamet Pharmaceuticals

Viamet is the primary developer and marketer of IMPAVIDO. Their manufacturing facilities are located in the United States, with robust quality control processes adhering to Good Manufacturing Practices (GMP). Viamet retains exclusive licensing rights for IMPAVIDO in certain jurisdictions, specifically targeting onchocerciasis and strongyloidiasis treatment markets[1].

2. Contract Manufacturing Organizations (CMOs)

Viamet collaborates with several CMOs to produce the API and formulate IMPAVIDO for different markets. Notably:

• Pharmaceutical Manufacturing Facilities in North America and Europe: These facilities follow regulatory standards mandated by agencies such as the FDA and EMA and produce both API and finished dosage forms.
• Asian Manufacturers: Several Indonesian and Indian pharmaceutical companies have received licensing agreements to manufacture ivermectin formulations, including branded IMPAVIDO, for regional markets.

3. Generic Manufacturers

Although IMPAVIDO is a branded medication, numerous generic producers manufacture ivermectin-based formulations that are bioequivalent but marketed under different names. Some of these include:

• Macleods Pharmaceuticals (India): Produces ivermectin tablets used in regions where IMPAVIDO is not directly available.
• GSK (GlaxoSmithKline): Historically involved in ivermectin production, though primarily for other indications.
• Sun Pharmaceutical Industries: Holds licenses for ivermectin formulations, often supplied under generic branding.

While these generics are not branded as IMPAVIDO, they form the backbone of ivermectin supply across diverse markets and regions, especially in low to middle-income countries.

4. Regional Distributors and Suppliers

In endemic regions such as sub-Saharan Africa, Latin America, and Southeast Asia, multiple authorized distributors source ivermectin from licensed manufacturers to meet local demand. These regional distributors are integral for maintaining adequate supply levels in regions where IMPAVIDO is primarily used. Notable distributors include:

• Cipla Limited (India)
• Gydle Pharma (Bangladesh)
• Lupin Ltd (India)

These companies often operate under licensing agreements and fulfill government procurement needs.

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Regulatory and Licensing Dynamics

The supply landscape for IMPAVIDO is influenced heavily by regulatory approvals and licensing agreements. Viamet's exclusive rights limit direct competition under the IMPAVIDO brand but permit licensed generic manufacturing in certain territories, impacting overall supply diversity. Regulatory approvals from agencies like the FDA, EMA, WHO, and local health authorities authorize manufacturing and distribution, reinforcing supply chain integrity.

Furthermore, during public health crises like the COVID-19 pandemic, some manufacturers sought emergency use authorizations (EUAs) to distribute ivermectin-based formulations, including IMPAVIDO, although such measures are subject to regulatory scrutiny and vary across jurisdictions[2].

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Potential Supply Challenges and Market Dynamics

Despite a relatively robust supply network, certain factors threaten the consistent availability of IMPAVIDO:

• Manufacturing Capacity Constraints: Limited capacity among licensed manufacturers can lead to shortages.
• Regulatory Hurdles: Delays in approvals or manufacturing licenses in specific regions impact access.
• Patent and Licensing Limitations: Exclusive licensing agreements restrict generic competition in key markets, affecting price and availability.
• Global Demand Fluctuations: Rising demand driven by off-label use or misinformation can strain supply sources.
• Supply Chain Disruptions: Logistics issues, geopolitical factors, and raw material shortages can hamper production.

Efforts by organizations like the WHO and global health initiatives aim to mitigate these challenges by fostering licensing agreements and supporting local manufacturing capabilities.

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Emerging Trends and Future Outlook

The future supply dynamics for IMPAVIDO hinge on several factors:

• Expansion of licensing agreements in developing countries to increase regional manufacturing.
• Development of alternative formulations and biosimilars to augment supply.
• Increased regulatory harmonization to streamline approval processes.
• Potential inclusion in mass drug administration (MDA) programs for neglected tropical diseases, which could boost volume requirements.

Viamet and partners are actively working to expand manufacturing capacity and licensing frameworks, aiming to secure a stable supply chain capable of meeting global demands.

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Key Takeaways

• Multiple layers of manufacturing—from Viamet's proprietary facilities to licensed generic producers—compose IMPAVIDO’s supply chain.
• Regional distributors and generic manufacturers play a crucial role in ensuring access, especially in low-income and endemic areas.
• Regulatory licensing and approvals significantly influence supply availability; delays can cause shortages.
• Emerging supply risks, such as capacity constraints and logistical disruptions, necessitate strategic planning.
• Market expansion efforts by Viamet and partner organizations aim to diversify and stabilize supplies amid rising global health needs.

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FAQs

1. Who are the main manufacturers of IMPAVIDO?
Viamet Pharmaceuticals is the primary producer and marketer of IMPAVIDO. Licensed generic manufacturers, mainly in India and Indonesia, also produce ivermectin formulations for regional markets.

2. Is IMPAVIDO available as a generic?
While IMPAVIDO is a branded product, generic ivermectin formulations are widely available in various markets. However, they are marketed under different names, not as IMPAVIDO itself.

3. How does licensing affect the availability of IMPAVIDO?
Licensing agreements restrict manufacturing rights to certain companies and regions, which can influence supply consistency and pricing in various markets.

4. What are the key risks to IMPAVIDO supply?
Manufacturing capacity limitations, regulatory delays, geopolitical factors, and logistical issues pose risks to consistent availability.

5. Are there efforts to expand global IMPAVIDO supply?
Yes, Viamet collaborates with manufacturing partners and engages in licensing agreements to increase production capacity and ensure broader distribution, especially in underserved regions.

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References

[1] Viamet Pharmaceuticals. (2022). IMPAVIDO (ivermectin) product information.
[2] World Health Organization. (2021). Position statement on ivermectin use for COVID-19.