Bulk Pharmaceutical API Sources for ACCOLATE

Bulk Pharmaceutical API Sources for ACCOLATE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-850-873
Vitas-M Laboratory		STK646780
Amadis Chemical		A801752
AKos Consulting & Solutions		AKOS005577888
CAPOT		18223

Bulk Active Pharmaceutical Ingredient (API) Sources for ACCOLATE

Last updated: July 30, 2025

Introduction

Accolate, generically known as zafirlukast, is a leukotriene receptor antagonist primarily indicated for the management of asthma. As a niche pharmaceutical product, the sourcing of its active pharmaceutical ingredient (API)—zafirlukast—requires strategic considerations due to the complexity of synthesis, regulatory compliance, and global manufacturing practices. This article provides a comprehensive overview of bulk API sources for zafirlukast, emphasizing key manufacturing regions, supplier profiles, and regulatory standards to guide pharmaceutical companies and stakeholders in procurement and supply chain management.

Overview of Zafirlukast as an API

Zafirlukast is chemically characterized as a leukotriene receptor antagonist with a complex molecular structure, necessitating precise synthetic pathways. The API's synthesis involves multi-step reactions that demand high-quality raw materials and advanced manufacturing capabilities, often limiting production to specialized facilities with Good Manufacturing Practice (GMP) certifications.

Global Manufacturing Regions for Zafirlukast API

The sourcing landscape for zafirlukast API predominantly revolves around strategic regions known for specialty pharmaceutical API production:

1. India

India is a pivotal hub for API manufacturing owing to its extensive chemical industry, cost advantages, and a mature pharmaceutical ecosystem. Major Indian API producers possess robust GMP compliance and export capabilities, supporting global demand for zafirlukast. Notable companies include:

• Shilpa Medicare Ltd.: A WHO-GMP certified manufacturer with experience in leukotriene receptor antagonist APIs.
• A Isomeric Labs: Offering custom synthesis of complex APIs, including zafirlukast, with regulatory support for international markets.
• Divi's Laboratories: Known for high-purity APIs, they offer custom manufacturing for niche products like zafirlukast, adhering to global quality standards.

2. China

Chinese API manufacturers have significantly expanded their capabilities across high-value APIs. They provide bulk zafirlukast APIs often at competitive prices, with certifications aligning with international quality standards. Leading Chinese producers include:

• Baiyunshan Pharmaceutical: Engaged in complex API synthesis, with certifications for export markets.
• Hengli Chemical: Specializes in leukotriene receptor antagonists and other respiratory APIs, with extensive R&D and manufacturing infrastructures.

3. Europe

European API producers prioritize regulatory compliance, transparency, and high-quality standards. While typically catering to European markets, some suppliers offer APIs for export. Notable firms include:

• UCB Pharma: Based in Belgium, UCB has been involved in neuropsychiatric and respiratory APIs, including zafirlukast, emphasizing GMP compliance.
• Glenmark Pharmaceuticals (Europe division): Offers high-quality APIs, sometimes sourced from partner manufacturers, with a focus on the European regulatory environment.

4. United States

Although the U.S. market for zafirlukast API is smaller due to regulatory and patent considerations, certain US-based CDMOs (Contract Development and Manufacturing Organizations) provide manufacturing and sourcing solutions, mainly for clinical trial supply or within strategic partnerships.

Key Considerations for API Sourcing

When sourcing zafirlukast API, companies must evaluate the following critical factors:

• Regulatory Compliance: Ensure suppliers hold GMP certifications aligned with the target market (e.g., USFDA, EMA, CDSCO).
• Quality Assurance: Confirm quality control protocols, impurity profiles, and batch consistency.
• Supply Chain Reliability: Assess production capacity, lead times, and logistical robustness to prevent disruptions.
• Cost Structure: Balance price competitiveness with quality and regulatory adherence, especially in price-sensitive markets.
• Intellectual Property: Verify patent rights, especially considering zafirlukast patent status, to avoid infringement issues.

Emerging Trends in API Sourcing for Zafirlukast

Recent developments indicate increasing reliance on integrated regional supply chains, with Indian and Chinese manufacturers expanding their capacities for complex APIs like zafirlukast. Additionally, pharmaceutical companies explore strategic alliances with low-cost, high-quality suppliers to secure dependable APIs amid global supply chain disruptions.

Innovation in synthesis methods, such as green chemistry alternatives, is also influencing API sourcing, promising reduced environmental impact and potentially lower production costs.

Regulatory Landscape and Certification Standards

Sourcing from a compliant supplier is essential. Certificates of GMP, ISO certifications, and validated documentation are standard requisites. Regulatory bodies like the USFDA, EMA, and CDSCO maintain strict oversight, with many suppliers undergoing annual audits and compliance checks.

Conclusion

The procurement landscape for zafirlukast API is characterized by a dichotomy of regions—India and China as cost-competitive sources, and Europe and the US emphasizing regulatory rigor and quality assurance. For pharmaceutical companies, balancing these factors with supply reliability and regulatory compliance is paramount. Strategic collaborations and due diligence are vital to ensuring a resilient API supply chain for Accolate.

---

Key Takeaways

• India and China dominate the bulk API supply for zafirlukast, driven by cost efficiency and manufacturing capabilities.
• European and US suppliers focus on high-quality standards, often catering to regulated markets with stringent compliance requirements.
• Assessing vendors against GMP certification, quality control measures, and supply capacity is essential for risk mitigation.
• Emerging green chemistry processes could influence future API sourcing, driving sustainable manufacturing practices.
• Long-term contracts and strategic partnerships enhance supply security for APIs critical to respiratory disease management.

---

FAQs

1. Are there generic APIs available for zafirlukast, and how do they compare in quality?
Generic APIs for zafirlukast are produced mainly in India and China, matching international quality standards when sourced from GMP-compliant manufacturers. Regulatory approval depends on supplier certification, validation, and impurity profiles matching reference standards.

2. How can companies verify the authenticity and quality of zafirlukast APIs from overseas suppliers?
Verification involves reviewing GMP certification, conducting audits, requesting Certificates of Analysis (CoA), and performing third-party laboratory testing to confirm purity, potency, and impurity levels.

3. What are the key regulatory considerations when importing zafirlukast APIs?
Regulatory considerations include compliance with local authority registration (e.g., USFDA, EMA), adherence to Good Manufacturing Practices, and maintaining comprehensive documentation for traceability and audit readiness.

4. What impact has global supply chain disruption had on API sourcing for zafirlukast?
Disruptions have prompted companies to diversify supplier bases, increase inventory buffers, and explore regional manufacturing alliances to mitigate risks associated with geopolitical tensions and logistical challenges.

5. Is there potential for in-house synthesis of zafirlukast for larger pharmaceutical firms?
In-house synthesis is feasible but complex, requiring specialized expertise and infrastructure. Many firms prefer outsourcing to specialized manufacturers to reduce costs and minimize technical risks, unless high-volume production justifies internal capacity development.

---

Sources:

[1] U.S. Food and Drug Administration (FDA). Guidance for Industry: Good Manufacturing Practice Regulations for Finished Pharmaceuticals.
[2] World Health Organization (WHO). WHO Good Manufacturing Practices (GMP) for pharmaceutical products.
[3] Indian Pharmaceutical Alliance. API manufacturing capacity and quality profiles.
[4] European Medicines Agency (EMA). Pharmaceutical Quality Systems.
[5] Market research reports on global API manufacturing trends, 2022.