Bulk Pharmaceutical API Sources for SULFISOXAZOLE

Bulk Pharmaceutical API Sources for SULFISOXAZOLE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		S6377_SIGMA
Vitas-M Laboratory		STK400452
Molport		MolPort-000-422-016

Bulk Active Pharmaceutical Ingredient (API) Sources for: Sulfisoxazole

Last updated: July 28, 2025

Introduction

Sulfisoxazole is an antibiotic in the sulfonamide class, primarily utilized to treat urinary tract infections and certain bacterial infections. As a critical component of pharmaceutical formulations, sourcing high-quality bulk Active Pharmaceutical Ingredient (API) is integral for pharmaceutical manufacturers, wholesalers, and generic drug producers. This article offers an in-depth analysis of global API sources for sulfisoxazole, emphasizing regulatory compliance, manufacturing capabilities, supply chain considerations, and best practices for sourcing.

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Overview of Sulfisoxazole API

Sulfisoxazole belongs to the sulfonamide class of antibiotics, synthetic molecules characterized by a sulfonamide group attached to aromatic amines. The API's chemical stability, efficacy, and safety depend heavily on the manufacturing process and raw material integrity. Regulatory agencies such as the FDA, EMA, and WHO impose strict quality standards, including GMP compliance, for API production.

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Global API Manufacturing Landscape for Sulfisoxazole

1. Established API Manufacturers

Major pharmaceutical ingredient manufacturers have long-standing expertise in synthesizing sulfonamide antibiotics, including sulfisoxazole. Their production often stems from complex chemical synthesis processes involving multiple steps with strict control of impurities and quality parameters.

• United States and Canada:
  Companies like Hikal Inc., Roquette, and Thermo Fisher Scientific manufacture sulfisoxazole APIs, complying with cGMP standards. North American producers are distinguished by stringent quality assurance systems and robust regulatory compliance, enabling supply for US-based markets and export.

• India:
  India hosts a significant hub of API manufacturers with a robust supply chain for sulfonamides. Companies such as Eris Life Sciences, Laurus Labs, and Divis Labs produce sulfisoxazole APIs at competitive prices, adhering to GMP standards and WHO prequalification. Indian manufacturers benefit from cost advantages and high-volume production capacity.

• China:
  A leading producer globally, Chinese API manufacturers such as North China Pharmaceutical Group, Hengyang Pharma, and Hunan Jinhua Pharmaceutical produce sulfisoxazole at scale. Chinese manufacturers have expanded their reach through compliance with international standards and versions of cGMP, enabling exports to regulated markets.

• Europe:
  Several European companies, including Gedeon Richter and Sandoz (a Novartis division), are involved in sulfisoxazole API manufacturing, often catering to high-quality markets prioritized by strict regulatory standards.

2. Emerging and Contract Manufacturing Organizations (CMOs)

Emerging players and CMOs offer flexible, often cost-effective options for sourcing sulfisoxazole API. These organizations typically provide contract manufacturing services, including synthesis, formulation, and process development, useful for brands seeking quick scaling or pilot batch manufacturing.

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Regulatory and Quality Considerations

Sourcing sulfisoxazole API demands scrupulous adherence to regulatory standards. Key factors include:

• Good Manufacturing Practice (GMP) Certification:
  Ensures API quality, batch consistency, and contaminant control. Only manufacturers compliant with cGMP, as certified by regulatory authorities, should be considered.

• Regulatory Approvals and Prequalification:
  For international markets, especially WHO prequalified APIs or FDA-approved suppliers, these credentials facilitate market entry and compliance.

• Analytical and Quality Documentation:
  Certificates of Analysis (CoA), Certificates of Suitability (CEPs), and compliance with pharmacopeial standards (USP, European Pharmacopoeia) are essential.

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Supply Chain and Market Dynamics

The global API supply chain for sulfisoxazole faces several challenges and opportunities:

• Price Fluctuations:
  Market dynamics, raw material availability, and production costs influence API pricing. Indian and Chinese producers often offer competitive rates, but quality verification is crucial.

• Supply Security:
  The COVID-19 pandemic exposed vulnerabilities in global supply chains, emphasizing the need for diversified sourcing. Long-term contracts and multiple supplier relationships mitigate supply risks.

• Sustainability and Environmental Concerns:
  Manufacturers adopting eco-friendly, sustainable synthesis processes are gaining favor, especially for markets with strict environmental regulations.

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Selection Criteria for API Suppliers

• Regulatory compliance (GMP, certifications)
• Production capacity and scalability
• Quality assurance programs
• Supply reliability and delivery timelines
• Cost-effectiveness
• Environmental and sustainability practices

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Major API Suppliers for Sulfisoxazole

Manufacturer/Region	Certification & Compliance	Notes
Hikal Ltd. (India)	cGMP, WHO Prequalified	Leading supplier with extensive global reach.
Laurus Labs (India)	GMP, US DMF, CEP	Cost-effective manufacturing, reliable supply.
Divis Labs (India)	GMP, US DMF, CEP	Known for high-quality standards and innovation.
North China Pharmaceutical Group (China)	GMP, CE certification	Extensive capacity, emerging global reputation.
Hengyang Pharma (China)	GMP	Competitive pricing, expanding export footprint.
Gedeon Richter (Europe)	EMA-approved API	High regulatory standards, suitable for regulated markets.

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Ensuring Qualified API Sourcing

To mitigate risks associated with API quality and supply interruptions, pharmaceutical companies should:

• Conduct systematic supplier audits
• Verify regulatory credentials and batch records
• Establish contractual quality agreements
• Maintain diversified supplier portfolios
• Ensure traceability and transparency in the supply chain

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Conclusion

Sulfisoxazole API sourcing aligns with a global landscape characterized by mature Indian and Chinese manufacturers, with European players providing high-standard options for stringent markets. Prioritizing GMP compliance, regulatory certification, and supply chain resilience remains paramount. As demand continues, especially for generic and off-patent antibiotics, strategic sourcing will be a key determinant of operational success in pharmaceutical manufacturing.

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Key Takeaways

• Emerging Markets Lead: Indian and Chinese manufacturers dominate bulk sulfisoxazole API supply, offering competitive prices complemented by scalable production and regulatory compliance.
• Regulatory Vigilance Essential: Buyers must verify GMP certification, regulatory approvals (FDA, EMA, WHO), and quality documentation.
• Supply Chain Diversification: Establishing relationships with multiple suppliers reduces risks linked to geopolitical, environmental, or logistical disruptions.
• Quality Assurance Is Paramount: High-quality APIs facilitate regulatory approval and market acceptance, especially in heavily regulated markets.
• Eco-friendly Manufacturing: Producers adopting sustainable practices are increasingly favored, aligning with global environmental standards.

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FAQs

1. What are the primary regions for sourcing sulfisoxazole API?
India and China are the leading producers, with European suppliers offering high-regulatory-compliance options. North America also has specialized manufacturers serving regional needs.

2. How can I verify the quality of sulfisoxazole API suppliers?
Check for GMP certification, US/FDA approval, CE certification, Certificates of Analysis, and reference audits or third-party assessments.

3. What considerations are critical when contracting sulfisoxazole API?
Focus on regulatory compliance, quality consistency, supply reliability, production capacity, and environmental standards.

4. How does price influence API sourcing decisions?
While cost is important, prioritizing quality and supply security ensures regulatory compliance and minimizes manufacturing risk.

5. Is there a trend towards sustainable API manufacturing for antibiotics like sulfisoxazole?
Yes, manufacturers are adopting greener synthesis methods to meet environmental regulations and corporate sustainability goals, influencing sourcing decisions.

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Sources

[1] U.S. Pharmacopeia. USP Monograph for Sulfisoxazole.
[2] GlobalData. API Market Intelligence Report.
[3] Indian Pharmaceutical Alliance. 2022 API Manufacturing Status.
[4] Chinese Pharmaceutical Industry Reports. 2021 Production and Export Data.
[5] European Medicines Agency. API Certification Standards.