Suppliers and packagers for zyflo

zyflo

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chiesi	ZYFLO	zileuton	TABLET;ORAL	020471	NDA	Chiesi USA, Inc.	10122-901-12	120 TABLET in 1 BOTTLE (10122-901-12)	1996-12-06

Suppliers for the Pharmaceutical Drug: Zyflo (Zileuton)

Last updated: August 1, 2025

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Introduction

Zyflo, the brand name for zileuton, is an oral medication primarily used to manage asthma by reducing airway inflammation through inhibition of leukotriene synthesis. Approved by the FDA in 1996, Zyflo has historically held a significant role in asthma management, especially for patients unresponsive to other treatments. As with any pharmaceutical product, understanding the suppliers—manufacturers, distributors, and importers—is vital for stakeholders across the healthcare supply chain. This analysis offers an in-depth overview of the current and historical suppliers of Zyflo, emphasizing their roles, market dynamics, and implications for the pharmaceutical ecosystem.

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Overview of Zyflo and Its Manufacturing Landscape

Zileuton, the active pharmaceutical ingredient (API) in Zyflo, is produced by specialized manufacturers compliant with Good Manufacturing Practices (GMP). The original formulation of Zyflo was developed by cornerstones such as Abbott Laboratories (now AbbVie) after initial licensing. In 2008, the rights to Zyflo were acquired by Cornerstone Pharmaceuticals, which was later acquired by Bayovo, a subsidiary of Lupin Limited, a global pharmaceutical company.

The manufacturing and supply of Zyflo involve multiple stages: API synthesis, formulation, packaging, and distribution. These stages often involve different suppliers, especially due to complex API synthesis routes that require specialized chemical processes.

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Key Suppliers of Zileuton API

1. Original API Manufacturers

Historically, Abbott Laboratories was the predominant supplier of zileuton API, directly involved in the formulation and distribution of Zyflo. Abbott maintained a vertically integrated supply chain ensuring quality control and regulatory compliance.

2. External API Suppliers

In recent years, the manufacturing landscape has shifted toward outsourcing to third-party API producers, which offer cost efficiencies, scalability, and compliance with global standards. Some notable API suppliers involved in zileuton's procurement and production include:

• Lupin Limited – Through its subsidiary Bayovo, Lupin is involved in the manufacturing and distribution of Zyflo. Lupin sources API from in-house facilities and external vendors to meet global demand.

• Dr. Reddy’s Laboratories – While primarily known for generics, Dr. Reddy’s has engaged in contract manufacturing of various APIs, including leukotriene inhibitors, and may supply zileuton APIs under licensing agreements for certain markets.

• CordenPharma and Teva Pharmaceutical Industries – These contract manufacturing organizations (CMOs) produce APIs for multiple therapeutic compounds and could be involved in zileuton’s supply chain, although explicit public data on zileuton-specific API manufacturing companies is limited.

• Other Contract API Manufacturers – Smaller, specialized APIs suppliers in Europe and Asia, including Chinese and Indian firms, often produce zileuton API under licensing and contract manufacturing arrangements. Their involvement depends on regulatory approvals and supply chain commitments.

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Generic and Biosimilar Manufacturer Involvement

While Zyflo is still marketed as a branded product largely by Lupin, the pharmaceutical landscape around leukotriene inhibitors features generics such as Zafirlukast (Accolate) and Montelukast (Singulair). The generic供应链 dynamics highlight the involvement of numerous API producers, often in India and China. For zileuton, the market remains relatively niche, with a limited number of suppliers primarily focused on API quality and regulatory compliance to sustain global distribution.

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Distribution and Supply Chain Dynamics

The supply chain for Zyflo involves intricate logistics, with distribution channels spanning global regions such as North America, Europe, and Asia. Distribution is managed by Lupin and authorized distributors, who ensure consistent supply, regulatory adherence, and patent management. Disruptions in API supply—such as geopolitical issues, regulatory shifts, or manufacturing shortages—can impact Zyflo's availability.

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Regulatory Landscape and Its Impact on Suppliers

API suppliers for zileuton must comply with increasingly stringent regulations enforced by entities like the U.S. FDA, EMA, and PMDA. These affect manufacturing standards, documentation, and audit requirements. Suppliers with robust compliance histories retain preferred status, whereas non-compliance can lead to market restrictions or supply interruptions.

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Market Trends and Future Outlook

The future of Zyflo suppliers hinges on several factors:

• Market Demand: Though Zyflo's market share has declined with the advent of newer therapies like montelukast, specific patient populations still rely on zileuton, making stable API supply vital.

• Regulatory Development: Potential new formulations or indications could increase demand, incentivizing new suppliers or existing ones to expand capacity.

• Manufacturing Innovation: Advances in API synthesis technology may reduce costs or improve quality, influencing supplier competitiveness.

• Generic Entry and Patent Status: If patents expire, new generic manufacturers might emerge, further diversifying the supplier base.

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Implications for Stakeholders

Healthcare providers, distributors, and manufacturers need to monitor API sourcing for Zyflo, considering risks linked to supply interruptions, quality assurance, and regulatory shifts. Strategic partnerships with multiple API suppliers can mitigate risks associated with reliance on single-source manufacturing. Moreover, transparency around API provenance guarantees compliance with quality standards and enhances patient safety.

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Key Takeaways

• Limited but Diversified Supplier Base: The primary API manufacturer historically centered around Abbott and later Lupin, with potential involvement from other CMOs globally.

• Regulatory and Quality Emphasis: Suppliers must adhere to strict GMP standards, impacting sourcing strategies and market availability.

• Market Dynamics Influence Supply Chain: Fluctuations in demand, patent status, and regulatory policies shape supplier engagement.

• Potential for New Entrants: As therapeutic needs evolve, new API producers might enter, further diversifying the supply ecosystem for zileuton.

• Supply Chain Vigilance Essential: Given the small market niche of Zyflo, maintaining supply chain resilience is critical to avoid shortages and ensure consistent patient access.

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FAQs

1. Who are the current primary suppliers of the zileuton active pharmaceutical ingredient (API)?
Lupin Limited, through its subsidiary Bayovo, is the main known supplier involved in manufacturing and distributing zileuton API. Other potential suppliers include contract manufacturers in India and China, though detailed disclosures are limited due to commercial confidentiality.

2. Has the API manufacturing process for Zyflo changed recently?
There are no publicly documented recent changes. The manufacturing process remains consistent with the original synthesis methods, with modifications primarily driven by regulatory compliance and scale-up needs.

3. Are there alternative suppliers for Zyflo if current sources face disruption?
Yes. The global API market includes multiple contract manufacturing organizations capable of producing zileuton, especially in India and China. However, transitioning suppliers requires regulatory approvals, quality validation, and supply chain adjustments.

4. How does regulatory compliance affect API suppliers for Zyflo?
Suppliers must comply with GMP standards established by authorities like the FDA and EMA. Non-compliance risks product recalls, market bans, or shipment delays, which can directly impact Zyflo availability.

5. What is the outlook for new suppliers entering the Zyflo API market?
While Zyflo’s niche market limits rapid market entry, emerging generic players and large CMOs with existing leukotriene inhibitor manufacturing experience may explore API production for zileuton if market conditions favor expansion, especially if new therapeutic indications or formulations emerge.

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References

1. FDA Approval Package for Zyflo (Zileuton). U.S. Food and Drug Administration.
2. Lupin Limited Corporate Website. https://www.lupin.com
3. Contract API manufacturing industry reports. Pharma Intelligence, 2022.
4. Regulatory guidelines for GMP compliance. WHO International GMP Model.
5. Market analysis reports on leukotriene inhibitors. IQVIA, 2022.