Bulk Pharmaceutical API Sources for MONTELUKAST SODIUM

Bulk Pharmaceutical API Sources for MONTELUKAST SODIUM

Vendor	Vendor Homepage	Vendor Sku	API Url
NIH Clinical Collection		SAM001246657
NovoSeek		23663996
MolPort		MolPort-002-885-842
ChemMol		44000614

Bulk Active Pharmaceutical Ingredient (API) Sources for: MONTELUKAST SODIUM

Last updated: July 30, 2025

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Introduction

Montelukast sodium, a leukotriene receptor antagonist, is a prominent medication used for asthma, allergic rhinitis, and other respiratory conditions. As with any pharmaceutical product, the quality, reliability, and regulatory compliance of the active pharmaceutical ingredient (API) are critical factors for pharmaceutical manufacturers. This article analyzes the primary global sources for bulk montelukast sodium, highlighting market dynamics, key manufacturers, and sourcing considerations, providing insight for stakeholders seeking stable and compliant supply chains.

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Global Market Overview for Montelukast Sodium API

The global API market for montelukast sodium is characterized by a combination of established manufacturers and emerging suppliers, primarily located across Asia, Europe, and North America. China and India dominate API sourcing for numerous pharmaceuticals due to cost advantages, manufacturing capacity, and regulatory frameworks conducive to large-scale production. However, strict regulatory requirements from global agencies necessitate rigorous quality controls and compliance measures.

The demand for montelukast sodium continues to grow driven by increased prevalence of respiratory diseases, expanding indications, and the rising global healthcare expenditure. As such, supply chain resilience and quality assurance remain vital considerations in API procurement.

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Leading Manufacturers of Montelukast Sodium API

1. Zhejiang Tianyu Pharmaceutical Co., Ltd., China

Zhejiang Tianyu Pharmaceutical is a prominent Chinese API producer with a strong portfolio in respiratory APIs. The company emphasizes quality assurance and adheres to Good Manufacturing Practices (GMP), offering high-purity montelukast sodium suitable for global markets, including the US, EU, and emerging markets.

2. Hubei Yuanzhong Pharmaceutical Co., Ltd., China

Yuanzhong Pharmaceutical specializes in synthesizing high-quality APIs for respiratory and chronic disease medications. Their montelukast sodium API is recognized for compliance with international standards, competitive pricing, and consistent supply.

3. Natco Pharma Ltd., India

Natco is an established Indian pharmaceutical company with both finished formulations and API manufacturing capabilities. Their montelukast sodium API benefits from their extensive R&D, quality systems, and global regulatory experience, making them a reliable source for international markets.

4. M. S. Aslam & Company, India

This manufacturer produces montelukast sodium API with certifications aligned with international quality standards, often supplying to generic pharmaceutical companies worldwide. Their strategic location provides logistical advantages from India’s well-developed pharmaceutical infrastructure.

5. Afton Biologicals Pvt. Ltd., India

Afton Biologicals operates as a contract manufacturer with capabilities to produce high-purity montelukast sodium, focusing on meeting international quality benchmarks, including US FDA, EMA, and PMDA standards.

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Emerging and Notable API Suppliers in Europe and North America

While Asia remains dominant in API manufacturing, regulatory changes and supply chain resilience initiatives have encouraged some companies in Europe and North America to develop local API production capacities:

• Thymoquin (EU-based): Specializes in respiratory API manufacturing, including montelukast sodium, emphasizing strict regulatory compliance.
• Novartis and Teva (North America and Europe): Augmented their supply chains through strategic alliances, sometimes sourcing APIs from trusted third-party manufacturers adhering to stringent regulatory standards.

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Sourcing Considerations

• Regulatory Compliance: Suppliers should maintain GMP certification, with potential for inspection by agencies such as the US FDA, EMA, or PMDA. Certificates of Analysis (CoA) and batch documentation are critical.

• Quality Assurance and Purity: High purity levels (typically >99%) are non-negotiable for API used in respiratory medication. Vendors should provide detailed stability data and validation reports.

• Supply Stability: Consider long-term relationships with multiple suppliers to hedge against disruptions, especially given geopolitical influences and pandemic-related supply chain challenges.

• Cost Factors: Pricing depends heavily on manufacturing scale, technology, and compliance levels. While China and India offer cost advantages, quality and regulatory acceptance influence sourcing decisions.

• Intellectual Property and Regulatory Considerations: Ensure suppliers do not infringe on patents or proprietary processes, particularly when sourcing for branded or patented formulations.

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Regulatory and Certification Benchmarks

Suppliers should demonstrate adherence to:

• GMP compliance
• ISO 9001 certification
• US FDA, EMA, or other relevant agency approvals
• INN (International Nonproprietary Name) recognition
• Environmental and safety certifications

These benchmarks facilitate smooth registration, importation, and distribution across multiple markets.

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Conclusion

The sourcing of montelukast sodium API is primarily concentrated among manufacturers in China and India, with increasing contributions from European suppliers. For pharmaceutical companies, ensuring compliance, quality, and supply stability is paramount. While cost considerations are considerable, regulatory adherence and quality standards should govern procurement decisions to ensure safety, efficacy, and market access.

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Key Takeaways

• The Chinese API market, led by Zhejiang Tianyu and others, dominates montelukast sodium supply, offering cost advantages and consistent quality.
• Indian manufacturers, including Natco and Afton Biologicals, provide reliable, GMP-compliant APIs aligned with international standards.
• European and North American manufacturers are emerging players, focusing on high-quality, locally sourced APIs to mitigate supply risks.
• Regulatory compliance, purity, and supply chain stability outweigh cost considerations in strategic sourcing decisions.
• Establishing multi-source agreements and conducting diligent supplier audits are critical steps in ensuring continuous, compliant API supply.

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FAQs

1. What are the primary regions for sourcing montelukast sodium API?
Asia (China and India) dominate the market, with emerging sources in Europe and North America.

2. How important is GMP certification for selecting an montelukast sodium API supplier?
GMP certification is essential to ensure quality, regulatory compliance, and acceptance across global markets.

3. What are key quality parameters for montelukast sodium API?
Purity (>99%), consistent batch-to-batch quality, stability, and absence of impurities are critical.

4. How can manufacturers mitigate supply chain risks for montelukast sodium API?
By sourcing from multiple certified suppliers, establishing long-term contracts, and monitoring regulatory updates.

5. Are there regulatory challenges when sourcing from Chinese API manufacturers?
Potential challenges include verifying compliance and establishing proper documentation; thorough audits mitigate these concerns.

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References

[1] World Health Organization. (2021). Guidelines on quality control methods for active pharmaceutical ingredients.

[2] U.S. Food & Drug Administration. (2022). API manufacturing standards and compliance.

[3] European Medicines Agency. (2022). Guidelines for manufacturing APIs.

[4] IQVIA. (2021). Global API Market Report.

[5] Pharmaceutical Technology. (2021). Emerging trends in API sourcing and regulation.