Bulk Pharmaceutical API Sources for MESALAMINE

Bulk Pharmaceutical API Sources for MESALAMINE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		A3537_SIGMA
Sigma-Aldrich		A6178_SIGMA
Sigma-Aldrich		A79809_ALDRICH
Vitas-M Laboratory		STK301678
TCI (Tokyo Chemical Industry)		A2291

Bulk Active Pharmaceutical Ingredient (API) Sources for Mesalamine

Last updated: July 28, 2025

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Introduction

Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a cornerstone in the treatment of inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. Its efficacy relies heavily on the consistent quality and reliable supply of the API. The pharmaceutical industry depends on a global network of API manufacturers, with the majority concentrated in specific regions. This article provides a comprehensive overview of the primary bulk API sources for mesalamine, exploring key manufacturers, geographic distribution, supply dynamics, and implications for stakeholders.

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Global Landscape of Mesalamine API Producers

Major Manufacturing Regions

• India: Dominates the production of generic APIs, including mesalamine, owing to their cost advantage, extensive manufacturing infrastructure, and established regulatory framework.

• China: A significant player with a rapidly expanding API sector, China supplies a substantial share of global APIs, including mesalamine, often at competitive prices.

• European Union and United States: Comprise a smaller market share but are known for high-quality, Good Manufacturing Practice (GMP)-compliant APIs, primarily for developed markets requiring stringent quality standards.

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Leading Manufacturers of Mesalamine API

Indian Suppliers

1. Sun Pharmaceutical Industries Ltd.

   • One of India's largest API producers.
   • Offers high-quality mesalamine APIs, compliant with global GMP standards.
   • Supplies both the domestic and international markets, with certifications such as USFDA, EDQM, and GMP (WHO).

2. Divi's Laboratories

   • Known for its high-purity APIs and advanced synthetic processes.
   • Carries certifications for several major markets, including the US and Europe.
   • Offers customized formulations and bulk APIs.

3. Lupin Limited

   • A leading Indian API manufacturer with significant capacity.
   • Provides cost-effective APIs with compliance to international standards.
   • Supplies both finished APIs and niche intermediates.

4. Aurobindo Pharma

   • Focuses on scalable production with a focus on quality.
   • Supplies mesalamine APIs globally, meeting multiple regulatory requirements.

Chinese Suppliers

1. North China Pharmaceutical Group (SPH) and Zhejiang Huahong Pharmaceutical

   • Major Chinese producers of mesalamine.
   • Focused on large-scale manufacturing capacity.
   • Typically export to India, Southeast Asia, and emerging markets.

2. Zhejiang Andason Pharmaceutical Co., Ltd.

   • Offers competitive pricing.
   • Focuses on consistent quality aligned with international standards.

European and US-based API Manufacturers

1. Fresenius Kabi

   • A global player with high-quality APIs primarily for the European and US markets.
   • Emphasizes GMP compliance and regulatory adherence.

2. Pharmaceutics International Inc. (PII)

   • US-based API producer with a focus on high-grade APIs.
   • Supplies mesalamine for specialty markets requiring rigorous quality control.

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Supply Chain Considerations

• Quality Assurance and Regulatory Compliance: Not all APIs are created equal; manufacturers holding certifications such as USFDA, EMA, EDQM, or WHO-GMP are preferable for quality assurance.

• Price Sensitivity: Indian and Chinese manufacturers often offer more cost-effective options, vital for generic drug production.

• Lead Times and Capacity: Large-scale manufacturers with extensive capacity can ensure stable supply chains, critical amid global disruptions such as geopolitical tensions or pandemic-related bottlenecks.

• Traceability and Transparency: Increasing regulatory requirements necessitate transparent supply chains, with clear documentation and batch traceability.

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Emerging Trends and Future Outlook

• Regulatory Stringency: As global standards tighten, manufacturers are investing more in quality management systems, impacting sourcing decisions.

• Sustainable Manufacturing: Increasing emphasis on environmentally sustainable practices influences supplier selection.

• Technological Advancements: Continuous process improvements and synchronization with cGMP standards enhance overall supply reliability.

• Diversification of Suppliers: To mitigate risk, pharmaceutical companies are broadening their API supplier base across regions.

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Implications for Stakeholders

• Pharmaceutical Companies: Must verify supplier certifications and quality metrics before procurement.

• Regulators: Require robust documentation and audit trails for API sourcing, influencing supplier partnerships.

• Investors: Should monitor geopolitical factors influencing supply chains, particularly in China and India.

• Patients: Depend on a reliable supply chain to ensure medication availability and consistent therapeutic efficacy.

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Key Takeaways

• The global API market for mesalamine is predominantly led by Indian, Chinese, and select Western manufacturers.
• Indian companies, such as Sun Pharma, Divi's Laboratories, and Lupin, dominate the low-cost, large-volume segment with high compliance standards.
• Chinese manufacturers offer competitive pricing but require diligent quality validation.
• High-quality APIs from European and US manufacturers are essential for markets with stringent regulatory demands.
• Supply stability hinges on regulatory adherence, capacity planning, and diversification strategies.

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Conclusion

The sourcing landscape of mesalamine API reflects a dynamic balance between cost efficiency, regulatory compliance, and supply reliability. Pharmaceuticals and generics producers must evaluate supplier credentials carefully, considering regional strengths and evolving industry standards. As the demand for mesalamine continues to grow globally, a diversified and quality-focused API supplier network will be crucial for ensuring uninterrupted patient access to essential medications.

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FAQs

1. What are the primary regions manufacturing mesalamine API?
India and China are the main global producers, with European and US-based vendors serving high-regulatory markets.

2. How can companies ensure the quality of mesalamine APIs?
By verifying certifications such as USFDA, EDQM, or WHO-GMP, conducting supplier audits, and reviewing batch consistency data.

3. What factors influence the choice of mesalamine API suppliers?
Cost, quality, regulatory compliance, manufacturing capacity, lead times, and supply chain transparency.

4. Are there capable alternatives to Chinese and Indian mesalamine API suppliers?
Yes, European and US manufacturers provide high-quality APIs for premium markets but generally at higher costs.

5. How is the supply chain for mesalamine APIs expected to evolve?
It will likely become more diversified with increased emphasis on quality, regulatory compliance, and sustainable manufacturing practices.

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References

1. [1] "Global API Market Overview," Pharmaceutical Technology, 2022.
2. [2] "India's API Industry Outlook," Department of Pharmaceuticals, Government of India, 2021.
3. [3] "Chinese Pharmaceutical API Industry Report," China Pharma Insights, 2022.
4. [4] "Regulatory Standards for Pharmaceutical APIs," European Medicines Agency, 2023.
5. [5] "Emerging Trends in API Supply Chain," Journal of Pharmaceutical Sciences, 2022.