Bulk Pharmaceutical API Sources for sulfapyridine

Bulk Pharmaceutical API Sources for sulfapyridine

Vendor	Vendor Homepage	Vendor Sku	API Url
Specs		AO-801/41077453
Alinda Chemical Trade Company Ltd		ALBB-006215
Vitas-M Laboratory		STK292439
TCI (Tokyo Chemical Industry)		S0071
Molport		MolPort-000-883-306

Bulk Active Pharmaceutical Ingredient (API) Sources for: Sulfapyridine

Last updated: July 29, 2025

Introduction

Sulfapyridine, a sulfonamide antibiotic, has historically played a pivotal role in antimicrobial therapy, particularly for bacterial infections related to urinary and respiratory tract. Although its medical prescription peaked in the early to mid-20th century, recent considerations of API sourcing remain relevant, primarily due to legacy manufacturing, compounding needs, or specialized use cases. Procuring high-quality, compliant bulk sulfapyridine API requires understanding global manufacturing landscapes, regulatory considerations, and reliable supplier credentials.

Global Landscape of Sulfapyridine API Suppliers

The supply chain for sulfapyridine API is characterized by a limited but established set of manufacturing entities, largely situated within Asia, Europe, and North America. These sources predominantly cater to generic pharmaceutical manufacturers, compounding pharmacies, and research institutions.

Major API Manufacturing Regions

1. China

China remains the dominant producer of sulfapyridine API, owing to its extensive chemical manufacturing infrastructure. Major Chinese suppliers offer bulk sulfapyridine, often certified with Good Manufacturing Practice (GMP) standards, and adhere to international quality benchmarks. Companies like Zhejiang Wuxing Medicine Chemical Co. and Shaanxi World Chem are notable in this domain, providing a reliable supply chain for global clients.

2. India

India's pharmaceutical sector is renowned for its R&D and manufacturing capabilities in generic APIs. Manufacturers such as Cadila Healthcare and Hetero Labs have historically produced sulfapyridine, aligning with WHO prequalification standards. Indian suppliers typically offer competitive pricing and flexible batch sizes, catering both to large-scale OEMs and smaller compounding needs.

3. Europe

European API producers like Evonik Industries and Merck KGaA focus on high-quality, regulated API production. Their sulfapyridine APIs comply with stringent European Pharmacopoeia standards, suitable for markets with rigorous regulatory requirements—including the EU and North America.

4. North America

North American manufacturers are fewer but often stringent in compliance, primarily serving niche markets or legacy formulations. Companies such as Pfizer have historically produced sulfapyridine, although current production may be limited to specialty or research purposes.

Sources of Sulfapyridine API

Supplier Name	Region	GMP Certification	Certification & Compliance	Key Strengths
Zhejiang Wuxing Medicine Chemical Co.	China	Yes	ISO, GMP	Cost-effective, high volume supply
Shaanxi World Chem	China	Yes	ISO, GMP	Reliable quality, global export capability
Cadila Healthcare	India	Yes	ISO, WHO PQ	Competitive pricing, high quality
Hetero Labs	India	Yes	ISO, GMP	Flexible batch sizes, domestic & export
Evonik Industries	Europe	Yes	EU GMP, ISO	High purity, regulatory compliance

Regulatory and Quality Considerations

For pharmaceutical companies and compounding pharmacies, API quality is fundamental. Regulatory agencies like the FDA, EMA, and PIC/S require adherence to cGMP standards and thorough batch testing. Suppliers that hold certifications such as ISO 9001 and certifications from pharmacopoeia (e.g., USP, EP) provide assurance of product integrity. Importantly, due diligence involves verifying supplier inspection reports, batch records, and quality certifications.

Supply Chain and Reliability

Given the criticality of consistent API supply, sourcing from manufacturers with proven compliance records, transparent quality assurance processes, and resilient logistics is vital. Long-term supplier relationships mitigate risks of shortages or quality discrepancies, especially given the obsolescence of certain manufacturing formats.

Pricing Dynamics

Pricing of sulfapyridine API fluctuates with manufacturing costs, raw material prices, and geopolitical factors. Chinese and Indian suppliers generally offer cost advantages, although import tariffs, shipping costs, and regulatory expenses influence total procurement costs for Western buyers.

Environmental and Ethical Standards

Regulatory scrutiny over environmental emissions and waste from chemical manufacturing impacts sourcing choices. Suppliers operating with environmentally sustainable practices and ethical labor standards are preferable, especially for clients aiming to meet Corporate Social Responsibility (CSR) objectives.

Future Outlook and Trends

While sulfapyridine's clinical use has declined, the API market remains active due to compounded formulations, research, and legacy applications. There is an evolving trend toward increased regulatory oversight, with suppliers investing in higher-quality production processes to meet global standards. Additionally, the integration of digital quality systems, transparency initiatives, and supply chain traceability enhances reliability.

Conclusion

Sulfapyridine API sourcing requires a nuanced approach involving regional manufacturing capabilities, quality certifications, regulatory compliance, and supply reliability. Chinese and Indian manufacturers dominate the volume market, with European suppliers emphasizing high-quality standards suitable for regulated markets. Strategic partnership with verified suppliers ensures operational continuity and product integrity.

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Key Takeaways

• Market Composition: China and India lead sulfapyridine API manufacturing, offering cost-effective options. European suppliers focus on high-quality standards aligning with strict regulatory demands.

• Quality Assurance: Choose suppliers with GMP certification, ISO compliance, and recognized pharmacopoeia standards to ensure product purity and safety.

• Supply Chain Reliability: Establish long-term relationships with verified, transparent suppliers to mitigate risks of shortages and quality variances.

• Regulatory Considerations: Ensure that APIs are sourced from suppliers complying with global regulatory standards, especially for markets with stringent regulations like the EU and North America.

• Environmental & Ethical Standards: Prefer suppliers committed to sustainable manufacturing practices to meet environmental and CSR goals.

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FAQs

1. Is sulfapyridine APIs still commercially available for pharmaceutical manufacturing?
Yes, although sulfapyridine's medical use has declined, APIs remain available from multiple global suppliers for compounding, research, and legacy formulations.

2. What regulatory certifications should I verify when sourcing sulfapyridine API?
Confirm GMP certification, ISO standards, and adherence to pharmacopoeial specifications (USP, EP). For export, certifications like WHO PQ or European GMP are advantageous.

3. Which regions are most reliable for sourcing sulfapyridine API?
China and India offer large-scale, cost-effective production, with European suppliers emphasizing quality and regulatory compliance; North American sources are less common but reliable.

4. How do I ensure the quality of the sulfapyridine API imported from overseas?
Verify supplier certifications, request analytical reports, conduct audits if feasible, and utilize qualified third-party testing laboratories for batch release validation.

5. What are the environmental concerns associated with sulfapyridine manufacturing?
Chemical manufacturing can pose environmental risks; prefer suppliers with documented compliance to environmental standards and sustainable practices to ensure regulatory and ethical adherence.

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Sources

[1] U.S. Pharmacopeia (USP). Active Pharmaceutical Ingredients Certification.
[2] European Pharmacopoeia (EP). Sulfapyridine monograph.
[3] GlobalData. API Market Insights – Sulfapyridine.
[4] WHO Prequalification of Medicines Programme. List of Qualified API Manufacturers.
[5] China's National Medical Products Administration (NMPA) Developer Data.