Bulk Pharmaceutical API Sources for AZULFIDINE EN-TABS

Bulk Pharmaceutical API Sources for AZULFIDINE EN-TABS

Vendor	Vendor Homepage	Vendor Sku	API Url
TCI (Tokyo Chemical Industry)		S0580
Molport		MolPort-001-792-507
Molport		MolPort-003-986-992

Bulk Active Pharmaceutical Ingredient (API) Sources for AZULFIDINE EN-TABS

Last updated: August 15, 2025

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Introduction

Azulfidine EN-Tabs, also known as sulfasalazine extended-release tablets, are a prescription medication primarily used in the management of ulcerative colitis and Crohn’s disease. As with all pharmaceutical products, the foundation of their efficacy and safety lies in the quality of their active pharmaceutical ingredient (API). This article provides a comprehensive overview of bulk API sources for sulfasalazine (the API in Azulfidine EN), highlighting key considerations for pharmaceutical manufacturers, supply chain integrity, regulatory standards, and global API suppliers.

Understanding Sulfasalazine: The API of Azulfidine EN-Tabs

Sulfasalazine is a complex, proprietary compound comprising a 5-aminosalicylic acid (5-ASA) linked to sulfapyridine via an azo bond. Its pharmacological activity derives from the release of 5-ASA in the colon, exerting anti-inflammatory effects, and from sulfapyridine, contributing antimicrobial properties.

The manufacturing of high-quality sulfasalazine requires precise control over chemical synthesis, purification, and manufacturing conditions, emphasizing the importance of sourcing from reliable API suppliers compliant with international standards.

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Global API Suppliers for Sulfasalazine

1. Key Geographic Regions and Leading Manufacturers

• India: India remains a dominant hub for generic API manufacturing, with companies such as Divi’s Laboratories, Hetero Labs, and Dr. Reddy's Laboratories producing sulfasalazine meeting international quality standards. These firms are often approved by major regulatory agencies (e.g., US FDA, EMA) and hold WHO prequalification, making them a prime source for global supply.

• China: Chinese manufacturers like Zhejiang Hisun Pharmaceutical Co. and Jiangsu Hengrui Medicine participate in API production, focusing on cost competitiveness. Stringent regulatory oversight, however, varies among Chinese producers, necessitating rigorous quality audits.

• Europe and North America: Fewer domestic manufacturers produce sulfasalazine APIs, mostly focusing on specialty, high-grade batches for regional markets or proprietary formulations, such as in Germany or the USA. Their APIs are highly regulated but serve as premium sources due to strict quality controls.

2. Leading API Manufacturers and Suppliers

Supplier	Location	Certification & Approvals	Notes
Divi’s Laboratories	India	WHO PQ, US FDA, EMA approvals	Large-scale, GMP-certified API producer
Hetero Labs	India	WHO PQ, US FDA, EMA approvals	Extensive API manufacturing capacity
Dr. Reddy's Laboratories	India	WHO PQ, US FDA approvals	Global presence, high-quality standards
Zhejiang Hisun Pharmaceutical	China	ISO certification, GMP compliance	Cost-competitive source
Jiangsu Hengrui Medicine	China	GMP certification, regional approvals	Increasing international presence

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Criteria for Selecting API Suppliers

Regulatory Compliance: Confirm suppliers possess necessary certifications such as WHO prequalification, US FDA approval, EMA certification, and ISO standards.

Quality Assurance: Audit their manufacturing facilities, stability data, impurity profiles, and batch consistency.

Supply Chain Security: Consider suppliers with robust logistics, contingency plans for supply disruptions, and transparent documentation.

Pricing & Contract Terms: Balance cost competitiveness with quality compliance; explore long-term agreements for stability.

Environmental and Ethical Standards: Ensure manufacturers adhere to environmental regulations, sustainability practices, and fair labor standards.

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Regulatory and Quality Considerations

The procurement of sulfasalazine API mandates strict adherence to Good Manufacturing Practices (GMP). Regulatory authorities such as the US FDA, EMA, and WHO enforce comprehensive standards for API production, including validation, impurity profiling, and batch release testing. Importers must verify API suppliers' certifications and conduct independent testing where possible.

Importantly, the API's origin impacts regulatory approval for finished Azulfidine EN-Tabs. For instance, APIs sourced from WHO prequalified suppliers streamline registration processes in developing markets, whereas APIs from unapproved sources could hinder approval or lead to compliance issues.

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Supply Chain Challenges

The global API market faces challenges like geopolitical disruptions, raw material shortages, and quality control scares, which can precipitate supply delays or quality issues. Diversification among multiple suppliers, strategic stockpiling, and transparent supply chain practices are critical for manufacturers to mitigate risks.

Emerging Trends and Future Outlook

The API landscape is increasingly shifting towards integrating digital quality controls, adopting continuous manufacturing processes, and embracing sustainable practices. Manufacturers investing in innovative synthesis routes and cleaner processes are expected to gain competitive advantages, especially as regulators tighten environmental standards.

Asia-Pacific remains the most significant API manufacturing region, with ongoing efforts to improve quality standards to meet international regulatory expectations. Industry consolidation and partnerships are likely to influence supply chain dynamics moving forward.

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Conclusion

Reliable bulk API sourcing for Azulfidine EN-Tabs, specifically sulfasalazine, hinges on selecting suppliers with proven quality records, international certifications, and robust supply chain management. Leading manufacturers from India and China dominate the global landscape, offering scalable and cost-effective options, but rigorous supplier qualification remains essential. As regulatory scrutiny intensifies, transparency and compliance will increasingly define procurement success.

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Key Takeaways

• India remains a primary hub for sulfasalazine API, featuring several WHO-prequalified and FDA-approved manufacturers ensuring high standards and reliable supply.

• Chinese API producers offer competitive pricing but require careful validation of quality compliance and regulatory standing.

• Due diligence, including auditing certifications, impurity profiles, and manufacturing practices, is vital before sourcing sulfasalazine API.

• Diversifying API sources and maintaining strategic inventory buffers can mitigate supply chain risks associated with geopolitical or logistical disruptions.

• Future industry advancements will focus on sustainability, digital manufacturing, and stricter regulatory standards, influencing API sourcing strategies.

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FAQs

1. What are the main factors to consider when sourcing sulfasalazine API for Azulfidine EN-Tabs?
Quality certifications (WHO PQ, FDA, EMA), manufacturing consistency, impurity profiles, supply chain reliability, pricing, and compliance with environmental and safety standards.

2. Which countries dominate the manufacturing of sulfasalazine API?
India and China are leading producers, with India hosting the majority of WHO-prequalified API manufacturers and China offering cost-competitive options.

3. How does API quality impact the safety and efficacy of Azulfidine EN-Tabs?
High-quality API ensures consistent therapeutic activity, minimal impurities, and predictable pharmacokinetics, directly impacting drug safety and efficacy.

4. Are there risks associated with sourcing APIs from Chinese manufacturers?
Potential risks include variable quality standards and regulatory oversight; hence, thorough supplier validation and audits are recommended to mitigate risks.

5. What future trends might influence API sourcing for sulfasalazine?
Growing emphasis on sustainable manufacturing practices, digital quality assurance, regulatory tightening, and supply chain resilience will shape sourcing strategies moving forward.

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References:

[1] World Health Organization. Prequalification of Medicines Programme. Sulfasalazine API profile.
[2] Hetero Labs Ltd. API manufacturing capabilities.
[3] Divi’s Laboratories Ltd. GMP-certified API production.
[4] European Medicines Agency. Guidance on sourcing APIs.
[5] U.S. Food and Drug Administration. API registration standards.