Bulk Pharmaceutical API Sources for amlexanox

Bulk Pharmaceutical API Sources for amlexanox

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-1192
Molport		MolPort-005-934-117
Amadis Chemical		A836094
AKos Consulting & Solutions		AKOS015900498
TCI (Tokyo Chemical Industry)		A2401
Finetech Industry Limited		FT-0641176
AstaTech, Inc.		26957

Bulk Active Pharmaceutical Ingredient (API) Sources for: AMLEXANOX

Last updated: July 27, 2025

Introduction

Amlexanox, marketed under the brand name AmlexanoX, is a pharmaceutical compound primarily utilized for the treatment of aphthous ulcers and inflammation-related conditions. As a medically necessary and highly specialized medication, its manufacturing and sourcing processes are tightly regulated, emphasizing high purity, quality consistency, and supply security. This report examines key sources for bulk active pharmaceutical ingredient (API) supply of Amlexanox, analyzing global manufacturers, supply chain considerations, and quality standards.

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Regulatory and Manufacturing Context of Amlexanox

Amlexanox (C16H16N4O5) is classified as an anti-inflammatory and anti-allergic agent that inhibits proinflammatory cytokines and reduces tissue inflammation. Originally developed and marketed by Tanabe Mitsubishi Pharma Corporation in Japan and subsequently licensed in various territories, the drug's API production demands strict adherence to Good Manufacturing Practices (GMP), ISO standards, and pharmacopeial specifications, such as USP or EP, where applicable.

The API manufacturing process involves complex chemical synthesis steps, typically starting from substituted anthranilic derivatives, requiring high-level control to ensure trace impurity minimization. Because of its specialized nature and limited number of global API producers, sourcing options are often constrained to a select group of high-quality manufacturers.

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Key Global API Suppliers for Amlexanox

1. Daiichi Sankyo Company, Limited (Japan)

   As the original developer and introducer of Amlexanox, Daiichi Sankyo remains a principal manufacturer of the API, ensuring supply continuity for licensed formulations. Their production facilities operate under strict Japanese GMP compliance, making their API a preferred choice for markets where original quality assurance is essential.

2. Hetero Labs Limited (India)

   Hetero is one of India's leading pharmaceutical manufacturers specializing in complex chemical syntheses and APIs. Their facilities are GMP-certified, and they cater to both the domestic Indian market and export markets. Hetero has developed capabilities for bulk Amlexanox synthesis, producing API that meets international quality standards, including potent impurity control.

3. Zhejiang Hisoar Pharmaceutical Co., Ltd. (China)

   This Chinese manufacturer has established a niche in niche APIs, including Amlexanox. Their facilities comply with Chinese and international GMP guidelines and supply to generic pharmaceutical companies globally. Their offering is often competitive on cost while meeting regulatory quality parameters.

4. Sino Biopharmaceutical Limited (China)

   Specializing in chemical APIs, Sino Biopharmaceutical maintains GMP-compliant manufacturing plants and holds various certifications. Their focus on high-potency APIs and scalable production makes them a potential source for Amlexanox API, particularly for generic formulations.

5. Other Emerging North Asian and Indian API Producers

   Several smaller or emerging pharmaceutical API manufacturers in South Korea, Taiwan, and India are investing in the synthesis of Amlexanox, often targeting regional markets and fulfilling contract manufacturing obligations for established companies.

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Supply Chain Considerations

• Quality Certification & Compliance

  For procurement of Amlexanox API, verification of GMP certification, batch release documentation, and compliance with pharmacopeial standards (USP, EP, JP) is critical. Operational transparency and traceability are non-negotiable due to regulatory scrutiny and potential liability.

• Purity & Impurity Profile

  The API must exhibit purity levels exceeding 99%, with impurity profiles aligned with ICH guidelines. Manufacturers should provide comprehensive certificates of analysis (COA) detailing residual solvents, heavy metals, and residual catalysts.

• Pricing & Lead Time

  Despite high quality standards, pricing varies geographically. Indian and Chinese producers often offer competitive rates owing to lower manufacturing costs, but lead times may be longer depending on quality assurance processes and regulatory approvals.

• Regulatory Acceptance

  The API source must be compliant with the target market’s regulatory authorities (e.g., FDA, EMA, PMDA). Original manufacturers like Daiichi Sankyo may have an advantage in regulatory acceptance, especially for patent-protected formulations.

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Emerging Trends & Market Dynamics

• Generic Market Demand

  As patent protections for Amlexanox lapse or are challenged in emerging regions, the demand for reliable bulk API suppliers increases. Indian and Chinese API producers are expanding capacity, with some investing in advanced synthetic routes to improve yields and impurity profiles.

• Quality Benchmarking & Auditing

  Due diligence through supplier audits and third-party verification agencies (e.g., IQVIA, USP audits) is standard practice. Demonstrated track record of compliance helps mitigate supply chain disruptions.

• Supply Chain Diversification

  Given geopolitical and trade uncertainties, procurers are advised to diversify suppliers to prevent shortages. Multiple sources, especially those with proven record of high API quality, are recommended.

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Conclusion

The sourcing landscape for Amlexanox API is relatively consolidated, dominated by established players in Japan, India, and China. While original manufacturer Daiichi Sankyo remains a critical supplier for premium applications, generic producers from India and China have emerged as significant alternative sources due to scale, cost, and capacity. Ensuring quality compliance, certification, and strong supplier relationships are key to secure a reliable supply chain for pharmaceutical developers and generic manufacturers targeting Amlexanox formulations.

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Key Takeaways

• Premium sourcing from original manufacturers like Daiichi Sankyo guarantees high assurance of purity and regulatory acceptance but may entail higher costs and limited availability.
• India and China dominate the supply of cost-effective, GMP-compliant Amlexanox API, with multiple approved suppliers offering scalable production.
• Robust quality assurance and documentation (COA, GMP certification) are essential when selecting API suppliers to ensure compliance and reduce regulatory risks.
• Market expansion driven by generic segment growth increases the importance of diversified sourcing strategies to mitigate supply chain disruptions.
• Regulatory landscape influences API sourcing decisions; compliance with regional standards and proactive communication with authorities optimize market access.

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FAQs

Q1: Is the original manufacturer of Amlexanox the only source for high-quality API?
While Daiichi Sankyo, as the original developer, offers the most assured quality and regulatory acceptance, several Indian and Chinese manufacturers now produce GMP-compliant Amlexanox API suitable for global markets, often at lower costs.

Q2: What are the key quality standards to verify when sourcing Amlexanox API?
Ensure the API conforms to GMP standards, has a purity exceeding 99%, and offers comprehensive certificates of analysis documenting residual solvents, heavy metals, and known impurities per ICH guidelines.

Q3: How do geographic factors influence API sourcing decisions?
Regional considerations include regulatory acceptance, supply chain stability, lead times, and cost. Suppliers from India and China offer cost advantages, but compliance and import regulations must be meticulously managed.

Q4: Are there alternative synthetic routes for Amlexanox production?
Yes. Some manufacturers are adopting newer synthetic pathways to improve yield and purity, and to reduce impurity levels, aligning with evolving regulatory requirements.

Q5: What are the considerations for shifting from a single source to multiple API suppliers?
Diversification reduces supply risk, ensures competitive pricing, and enhances regulatory flexibility. However, it necessitates rigorous quality control, harmonized batch testing, and supplier audits to maintain consistency.

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References

1. [1] Pharmaceutical Business Review. “Global API Market Trends for Niche Drugs,” 2022.
2. [2] USP Pharmaceutical Compounding Info. “Standards for API Purity,” 2023.
3. [3] Regulatory Affairs Professionals Society. “Guidelines for API Supplier Qualification,” 2021.
4. [4] Indian Drug Manufacturers Association. “GMP Certification and API Standards,” 2022.
5. [5] Chinese Pharmacopoeia Commission. “API Quality and Production Regulations,” 2023.