Bulk Pharmaceutical API Sources for ZYFLO CR

Bulk Pharmaceutical API Sources for ZYFLO CR

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246738
NovoSeek		60490
MolPort		MolPort-003-850-877

Bulk Active Pharmaceutical Ingredient (API) Sources for ZYFLO CR

Last updated: July 28, 2025

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Introduction

ZYFLO CR (zileuton extended-release tablets) is a prescription medication approved by the FDA primarily for managing asthma symptoms. Its active pharmaceutical ingredient (API), zileuton, serves as a selective inhibitor of 5-lipoxygenase, thus reducing leukotriene production and inflammation in airway tissues. Ensuring a consistent, high-quality API supply is critical for manufacturers seeking to produce ZYFLO CR, especially given the regulatory and efficacy standards associated with asthma therapeutics. This report explores the current landscape of API sourcing options for zileuton, analyzing key suppliers, regional considerations, supply chain stability, and regulatory compliance.

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Overview of API Supply Chain for Zileuton

The API supply chain for zileuton involves multiple stages, including chemical synthesis, purification, quality control, and packaging before integration into the final ZYFLO CR product. The complexity of API synthesis influences vendor selection, with pharmaceutical companies prioritizing suppliers capable of meeting strict Good Manufacturing Practices (GMP), institutional reliability, and consistent supply capacities.

Historically, the primary API manufacturing for zileuton has been concentrated in regions with advanced pharmaceutical industries, notably India and China, due to their extensive capabilities in bulk API production and cost competitiveness. Recently, there’s an increased emphasis on regulatory compliance, resulting in geopolitical considerations impacting sourcing strategies.

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Key API Suppliers for Zileuton

1. Indian Pharmaceutical Manufacturers

India remains the predominant source of zileuton API, driven by its robust pharmaceutical sector and cost-effective manufacturing. Several companies possess GMP certifications for zileuton API production:

• Suven Life Sciences
  A reputed API manufacturer with extensive experience in respiratory API synthesis. Suven's facilities adhere to USFDA, EMA, and ICH standards, securing their position as a reliable supplier for global markets. Their APIs are well-regarded for high purity and consistent supply.

• Hetero Labs
  Known for a broad portfolio, Hetero produces zileuton API with adherence to international quality standards. Their strategic focus on compliance and capacity ensures readiness for high-volume demand and possible supply chain disruptions.

• Lupin Limited
  Lupin's API division produces zileuton suitable for both domestic and export markets. Their extensive manufacturing facilities and ongoing investments in Quality Control (QC) contribute to product reliability.

2. Chinese API Manufacturers

Chinese API producers have expanded their role in respiratory API manufacturing, with many certified under international standards:

• Jiangsu Hengrui Medicine Co., Ltd.
  A leading Chinese pharmaceutical company with a history of API production for respiratory drugs, including zileuton. Their GMP-certified facilities and scalability make them a strategic choice.

• Qingdao Basi Pharmaceutical Co., Ltd.
  Focused on chemical synthesis, Basi provides zileuton API with competitive pricing, though due diligence regarding regulatory compliance remains essential for market approval.

3. Contract Manufacturing and Exporters

Third-party CMOs (Contract Manufacturing Organizations) often serve as intermediaries, sourcing APIs from primary suppliers and offering consolidations for pharmaceutical firms seeking reliable procurement channels. Examples include:

• MediChem (India)
  Offers sourcing, quality assurance, and supply chain solutions for zileuton API, often providing options for custom synthesis depending on specific purity and formulation requirements.

• APIs from Global Distributors
  Multiple international distributors, like Spectrum Chemical, ChemExpress, or chemSHIELD, source APIs globally, offering certified zileuton API stocks conforming to various regulatory standards.

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Regional Considerations and Supply Chain Dynamics

India and China: The Core API Suppliers

India and China dominate API production, owing to large-scale chemical manufacturing infrastructure and cost advantages. However, geopolitical tensions, import/export restrictions, and compliance with international regulatory standards influence supply stability.

Regulatory and Quality Compliance

Quality assurance is paramount; suppliers must possess certifications such as cGMP, USFDA, EMA, or PMDA approvals. Due diligence involves auditing suppliers' manufacturing practices, reviewing inspection reports, and validating stability data, especially for products destined for stringent markets like the U.S. and Europe.

Supply Chain Risks and Mitigation

The ongoing global disruptions, including the COVID-19 pandemic, have underscored vulnerabilities in API supply chains. Manufacturers are increasingly diversifying suppliers, establishing dual sourcing agreements, and maintaining safety stock inventories to mitigate risks.

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Emerging Trends and Future Outlook

• Vertical Integration and In-house API Production: Some pharmaceutical companies may aim to internalize API manufacturing to control quality and supply timelines better.

• Focus on Sustainable and Green Chemistry: Supply chain sustainability is gaining importance, with suppliers adopting environmentally friendly synthesis routes.

• Regulatory Harmonization: Greater focus on compliance with international standards can influence the selection of API suppliers, favoring those with recognized certifications.

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Conclusion

Securing a reliable, high-quality API source for zileuton (ZYFLO CR) requires navigating a complex landscape of regional providers, regulatory standards, and supply chain risks. Indian manufacturers like Suven Life Sciences, Hetero Labs, and Lupin are prominent global suppliers, complemented by Chinese firms such as Jiangsu Hengrui and Qingdao Basi. The decision to source from these providers hinges on regulatory compliance, manufacturing capacity, quality assurance, and geopolitical stability. As global supply chains evolve, manufacturers must adopt comprehensive sourcing strategies, including vendor audits, quality assurances, and risk management protocols, to ensure uninterrupted, compliant API supply for ZYFLO CR production.

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Key Takeaways

• Indian and Chinese pharmaceutical manufacturers dominate zileuton API supply, driven by cost efficiency and manufacturing capacity.
• Regulatory compliance (cGMP, USFDA, EMA) is the cornerstone of supplier selection for international markets.
• Diversification and strategic supplier relationships mitigate risks associated with geopolitical and pandemic-related disruptions.
• Ongoing industry trends favor sustainability, advanced quality controls, and supply chain transparency.
• Manufacturers should conduct thorough due diligence, including supplier audits and quality certification reviews, before establishing API procurement agreements.

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FAQs

1. What are the primary regions manufacturing API for ZYFLO CR?
India and China are the main regions, offering extensive GMP-compliant API production capabilities for zileuton, the active ingredient in ZYFLO CR.

2. How critical is regulatory compliance for API suppliers?
Regulatory compliance, including GMP certification and international approvals (USFDA, EMA), is essential to ensure product quality, safety, and market access.

3. What risks are associated with sourcing API from China or India?
Risks include regulatory differences, geopolitical tensions, quality variability, and supply chain disruptions, which can impact delivery timelines and compliance status.

4. How can manufacturers ensure the quality of their API sources?
Through supplier audits, review of certification documents, Stability and QC data assessments, and continuous supply chain monitoring.

5. Are there emerging alternatives to traditional API sourcing regions?
Yes, emerging markets and vertical integration strategies are increasing alternative sources; however, these are still developing compared to established Indian and Chinese manufacturers.

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Sources:
[1] U.S. Food and Drug Administration (FDA) Pharmaceuticals Data.
[2] European Medicines Agency (EMA) API manufacturing standards.
[3] Global API Market Reports (2022).
[4] Industry-Specific Supply Chain Analyses (2023).
[5] Company websites and regulatory filings for Suven Life Sciences, Hetero Labs, Lupin, Jiangsu Hengrui Medicine, Qingdao Basi Pharmaceutical.