Bulk Pharmaceutical API Sources for SODIUM SULAMYD

Bulk Pharmaceutical API Sources for SODIUM SULAMYD

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemBridge		5215942
Sigma-Aldrich		S8647_SIGMA
Sigma-Aldrich		86020_ALDRICH
Vitas-M Laboratory		STK023979
Molport		MolPort-002-136-723
Molport		MolPort-002-931-938

Bulk Active Pharmaceutical Ingredient (API) Sources for: SODIUM SULPHAMETHOXAZOLE (SULAMYD)

Last updated: July 27, 2025

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Introduction

Sodium Sulphamethoxazole (commonly referenced as Sulamyd) is a sulfonamide antimicrobial agent utilized in various pharmaceutical formulations, primarily for bacterial infections. As an essential API, its sourcing is critical for pharmaceutical manufacturers aiming for high-quality, cost-effective production. This report comprehensively examines global API suppliers specializing in Sodium Sulphamethoxazole, analyzing their manufacturing capacities, quality standards, compliance credentials, and strategic positioning within the supply chain.

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Overview of Sodium Sulphamethoxazole API Market

The global market for Sulphamethoxazole API is characterized by regional manufacturing hubs, primarily in Asia, Europe, and North America. Asia, especially India and China, dominates API production due to lower manufacturing costs and extensive pharmaceutical export infrastructure (see [1]). These regions host both large-scale API giants and specialized contract manufacturing organizations (CMOs), making the supply chain diverse and resilient.

The API's demand is driven by its role in fixed-dose combination drugs and standalone formulations targeting bacterial infections such as urinary tract infections and respiratory diseases. Regulatory standards necessitate rigorous quality controls, including cGMP compliance, to ensure API safety and efficacy.

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Major API Suppliers for Sodium Sulphamethoxazole

1. Zhejiang Huayuan Pharmaceutical Co., Ltd. (China)

• Overview & Capabilities: Zhejiang Huayuan is a notable producer of sulfonamide APIs with established cGMP-certified facilities. The company offers Sulphamethoxazole API at scales exceeding several hundred metric tons annually.
• Quality & Compliance: Certifications include ISO 9001, ISO 14001, and cGMP standards aligned with USFDA and EMA requirements.
• Key Strengths: Competitive pricing, robust supply chain, and proven export record in North America and Europe.
• Supply Experience: Serves multinational pharmaceutical firms, with a track record of high purity and consistent batch quality.

2. Fenol Pharma Ltd. (India)

• Overview & Capabilities: Fenol Pharma, operating under stringent Indian pharmaceutical regulations, supplies Sulphamethoxazole APIs to regional and international markets.
• Quality & Compliance: cGMP compliant, with quality assurance through HPLC purity tests (>99%) and batch-to-batch consistency.
• Market Position: Known for rapid delivery and flexible contract manufacturing solutions, supporting both generic and custom specifications.

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

• Overview & Capabilities: Specializes in sulfonamide APIs, including Sulphamethoxazole, with advanced synthesis capabilities enabling high purity production.
• Quality & Compliance: International certifications, including ISO and cGMP, with comprehensive stability data and bioequivalence reports.
• Strategic Advantages: Ability to scale production quickly, catering to emergent demands in infectious disease segments.

4. Anhui Tianpharma Co., Ltd. (China)

• Overview & Capabilities: A leading Chinese API manufacturer with extensive sulfanilamide portfolio, including Sulphamethoxazole.
• Quality & Compliance: Meets USFDA, EMA, and WHO standards, with robust QA/QC protocols.
• Distribution Network: Well-established channels ensuring reliable, timely delivery for global clients.

5. Zhejiang Medicine Co., Ltd. (China)

• Overview & Capabilities: A diversified pharmaceutical manufacturing group that produces multiple APIs, including Sulphamethoxazole.
• Quality & Compliance: Holds certifications such as ISO, cGMP, and GMP, with comprehensive documentation supporting regulatory submissions.
• Research & Development: Invests in process innovation, improving yield and API purity.

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Emerging and Contract Manufacturing Organizations (CMOs)

The landscape for Sulphamethoxazole API sourcing increasingly involves CMOs offering flexible manufacturing sizes and tailored quality controls. Notable players include:

• Jiangxi Huayu Pharmaceutical Co., Ltd. (China): Specializing in sulfonamide APIs with high-volume capacity and extensive compliance certifications.
• S&D Pharma (India): Focused on contract manufacturing of antibiotics, including Sulphamethoxazole, for multinational clients.

These organizations offer advantages in cost, regulatory expertise, and scalability, often partnering with established pharma companies to ensure regulatory compliance and batch consistency.

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Key Considerations for API Sourcing

• Regulatory Compliance: Sourcing from certified suppliers meeting cGMP, FDA, EMA, and WHO standards is essential to ensure approval readiness.
• Quality Assurance: High API purity (>99%) and stringent in-process controls reduce risks of impurities and batch failures.
• Manufacturing Capacity: Capacity for large-scale production to meet global demand, including contingency planning for supply shortages.
• Cost and Lead Times: Balancing pricing competitiveness with reliable delivery schedules is vital for supply chain stability.
• Supply Chain Transparency: Preference toward suppliers with traceability, clear documentation, and proven export track record.

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Challenges and Risk Mitigation

Despite a robust supplier network, risks include geopolitical disruptions, raw material shortages, and regulatory hurdles. Diversification across multiple certified suppliers mitigates dependency risks and ensures steady supply. Continuous audit and quality verification processes uphold compliance and product integrity.

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Conclusion

The sourcing of Sodium Sulphamethoxazole API involves a diverse landscape of regional manufacturers and CMOs. Leading suppliers in China and India offer extensive production capacities—suppliers like Zhejiang Huayuan Pharmaceutical and Fenol Pharma are prominent due to their scale, quality standards, and regulatory compliance. Strategic partnerships with these manufacturers enable pharmaceutical firms to maintain cost efficiency, quality, and supply chain resilience.

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Key Takeaways

• Global leader suppliers, primarily in China and India, dominate Sodium Sulphamethoxazole API production due to cost and infrastructure advantages.
• Regulatory compliance (cGMP, ISO, WHO, FDA/EMA standards) is non-negotiable for API procurement, impacting supplier selection.
• High-quality API (>99% purity with consistent batch performance) remains critical to meet regulatory and safety standards.
• Diversification of supply sources reduces risks associated with geopolitical issues and raw material interruptions.
• Emerging CMOs offer flexible, scalable manufacturing options suitable for custom formulations or urgent demand surges.

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FAQs

1. What are the primary regions producing Sodium Sulphamethoxazole API?
China and India are the dominant regions, with numerous manufacturers offering large-scale and compliant API production.

2. How do I verify the quality of a Sodium Sulphamethoxazole supplier?
Seek suppliers with certifications such as cGMP, ISO, FDA, and EMA approvals, along with detailed batch testing data, purity analysis (HPLC), and regulatory dossiers.

3. Can I source customized specifications for Sulphamethoxazole API?
Yes. Many CMOs and manufacturers offer tailored formulations, purity levels, and particle sizes to meet specific product requirements.

4. What are the typical lead times for API orders?
Lead times range from 4 to 12 weeks, depending on quantity, supplier readiness, and regulatory clearance processes.

5. What risks should I consider when sourcing Sulphamethoxazole API globally?
Risks include supply chain disruptions, quality discrepancies, regulatory compliance issues, and geopolitical tensions. Supplier diversification and quality audits mitigate these risks.

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References

[1] International Drug Price Indicator Guide, WHO.
[2] IQVIA. Global API Market Analysis.
[3] U.S. Food and Drug Administration (FDA). API Manufacturing Guidelines.
[4] European Medicines Agency (EMA). Good Manufacturing Practice (GMP) Guidelines.
[5] PharmaSources. Drug Master Files and API Supplier Directory.

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