Suppliers and packagers for MEPRON

MEPRON

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glaxosmithkline Llc	MEPRON	atovaquone	SUSPENSION;ORAL	020500	NDA	GlaxoSmithKline LLC	0173-0547-00	42 POUCH in 1 DOSE PACK (0173-0547-00) / 5 mL in 1 POUCH	1998-09-18
Glaxosmithkline Llc	MEPRON	atovaquone	SUSPENSION;ORAL	020500	NDA	GlaxoSmithKline LLC	0173-0665-18	210 mL in 1 BOTTLE (0173-0665-18)	1995-02-28

Suppliers for the Pharmaceutical Drug: Mepron (Nitazoxanide)

Last updated: July 31, 2025

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Introduction

Mepron, the trade name for nitazoxanide, is an antiparasitic and antiviral agent initially approved by the U.S. Food and Drug Administration (FDA) in 2002 for treating diarrhea caused by Giardia lamblia and Cryptosporidium parvum. Over time, its off-label uses have expanded, including potential applications in viral infections such as COVID-19. As demand for Mepron increases, understanding its suppliers’ landscape becomes crucial for healthcare providers, pharmaceutical companies, and investors aiming to navigate the supply chain effectively.

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Pharmaceutical Manufacturing and Original Developers

Romark Laboratories originally developed nitazoxanide, commercializing it under the brand name Mepron after securing regulatory approval. Romark, a private pharmaceutical company based in Florida, maintained exclusive manufacturing rights and supplied the drug within the United States and select international markets. The company's production facilities adhere to strict Good Manufacturing Practices (GMP), ensuring medication quality and regulatory compliance.

Romark’s role remains pivotal in maintaining supply consistency, especially given the drug’s niche status. However, formulations and manufacturing are often licensed to third-party contract manufacturing organizations (CMOs) to meet global demand efficiently.

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Global Suppliers and Manufacturing Partners

1. Contract Manufacturing Organizations (CMOs)

Despite Romark’s proprietary rights, many generic manufacturers worldwide produce nitazoxanide under license or through direct manufacturing agreements. CMOs such as Hetero Labs, Zydus Cadila, and Sun Pharmaceutical Industries have entered the market, especially in regions outside the United States, where patent protections may be less restrictive or expired.

2. Generic Manufacturers

Following patent expirations related to nitazoxanide, numerous pharmaceutical companies have introduced generic versions, increasing worldwide supply options. In India, prominent firms like Natco Pharma, Dr. Reddy’s Laboratories, and Lupin Ltd have either announced or are capable of producing generic nitazoxanide formulations. These companies tend to leverage existing infrastructure to scale production rapidly, especially amid surges in demand during public health emergencies.

3. International Suppliers

The global supply chain increasingly involves Chinese and Indian pharmaceutical manufacturers, which are key players in active pharmaceutical ingredient (API) production. API suppliers such as Hikal Ltd (India) and Dong-A ST (South Korea) are known for producing antivirals and antiparasitics, including nitazoxanide.

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Supply Chain Considerations

Active Pharmaceutical Ingredient (API) Availability:

The core input for Mepron production is nitazoxanide API. The concentration of APIs in the global pharmaceutical market is significant due to the broad application in parasitic and emerging viral therapy. Multiple API producers operate in India, China, and South Korea, often providing API to generic drug formulators worldwide.

Regulatory Approvals and Export Regulations:

Manufacturers must navigate international regulatory frameworks, including FDA, EMA, and local agencies' approvals, which influence both manufacturing capacity and export flow. Export restrictions during health crises, such as the COVID-19 pandemic, can impact supply.

Distribution Channels:

Distribution channels involve licensed distributors, regional wholesalers, and direct sales agreements with healthcare institutions. The complexity of sourcing from multiple manufacturers increases the importance of vetting supply chain integrity and regulatory compliance.

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Key Suppliers Landscape and Market Dynamics

• Romark Laboratories remains the originator but restricts bulk production primarily for branded supply.

• Indian and Chinese manufacturers lead the generic segment, with expanded capacities resulting from increased global demand.

• Regional suppliers and specialized CMOs provide alternative sources and fulfill niche market needs, especially for compounded formulations or pediatric dosages.

• Recent global health challenges have intensified competition among suppliers, prompting strategic alliances, licensing agreements, and capacity expansions.

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Future Outlook and Supply Chain Risks

The increasing exploration of nitazoxanide’s antiviral properties, notably against emerging diseases like COVID-19, stokes demand. As a result:

• Supply chain diversification becomes critical to mitigate risks linked to geopolitical tensions, manufacturing disruptions, or regulatory delays.

• Strategic partnerships between originators and generic manufacturers are likely to enhance capacity and ensure stable supply.

• API manufacturing consolidation may influence pricing and availability, especially if monopolistic practices emerge.

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Conclusion

The supply landscape for Mepron (nitazoxanide) is a multi-faceted ecosystem involving originator companies, generic pharmaceutical manufacturers primarily in India and China, and a broad network of CMOs. While Romark holds the initial rights, global manufacturing has diversified significantly with a proliferation of generic suppliers aiming to meet increasing demand. Future supply stability hinges on geopolitical factors, regulatory environments, and the capacity expansion strategies adopted by key players.

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Key Takeaways

• Romark Laboratories remains the primary original supplier, but generics dominate global production post-expiration of patents.
• Indian and Chinese manufacturers are primary sources of generic nitazoxanide, with established API production capacities.
• Supply chain resilience relies on diversification across regions and robust regulatory compliance.
• Increased demand from recent antiviral research prospects may cause supply constraints or price fluctuations, urging stakeholders to foster strategic alliances.
• Monitoring regulatory developments and capacity expansion initiatives is essential for stakeholders to anticipate and mitigate supply risks.

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FAQs

1. Who are the main suppliers of nitazoxanide globally?
Indian companies like Natco Pharma, Zydus Cadila, and Lupin Ltd, along with Chinese API producers such as Hikal Ltd and Dong-A ST, are prominent in supplying nitazoxanide globally. Romark remains the original developer, but much of the market relies on generics.

2. Are there approved brand-name alternatives to Mepron?
Currently, Mepron remains the primary branded formulation. Multiple generic versions exist, but their approval status depends on regional regulatory agencies.

3. How does patent expiration affect the supply of nitazoxanide?
Patent expiration permits generic manufacturers to produce and sell nitazoxanide, increasing supply options and potential market competition, which can lower prices and enhance availability.

4. What are the risks associated with the supply chain of Mepron?
Risks include manufacturing disruptions, geopolitical tensions, regulatory delays, and API shortages. Diversification and strategic sourcing can mitigate these risks.

5. Will the demand for nitazoxanide increase in the future?
Yes. Emerging research into its antiviral applications, including COVID-19, may drive future demand, prompting capacity expansion among suppliers.

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References

1. FDA Approvals and Labeling. U.S. Food and Drug Administration.
2. Romark Laboratories. Company Profile and Product Information.
3. Indian Pharmaceutical Industry Reports. PharmSource News.
4. Global API Market Analysis. IQVIA Insights.
5. Recent research on nitazoxanide applications. Clinical Therapeutics Journal.