Bulk Pharmaceutical API Sources for triple sulfa (sulfabenzamide;sulfacetamide;sulfathiazole)

Bulk Pharmaceutical API Sources for triple sulfa (sulfabenzamide;sulfacetamide;sulfathiazole)

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		60896
ABI Chem		AC1L1U4L
BenchChem		B1222622
THE BioTek		bt-1557500
J&H Chemical Co.,ltd		JH486186

Bulk Active Pharmaceutical Ingredient (API) Sources for Triple Sulfa Compounds: Sulfabenamide, Sulfacetamide, Sulfathiazole

Last updated: July 27, 2025

Introduction

The pharmaceutical industry relies on the consistent supply of Active Pharmaceutical Ingredients (APIs) for manufacturing effective antimicrobial agents. Drugs containing triple sulfa compounds—Sulfabenamide, Sulfacetamide, and Sulfathiazole—are characterized by their sulfur-based structures and potent antibacterial activity. Their production depends on a reliable network of sourcing API compounds from reputable suppliers globally, ensuring compliance with quality standards such as USP, EP, or JP. This report examines the current bulk API sources for these three compounds, analyzing key vendors, regions, and factors influencing procurement.

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Understanding Triple Sulfa Compounds

Triple sulfa drugs combine three sulfonamide motifs, targeting bacterial folic acid synthesis pathways. These compounds gained prominence in the mid-20th century and continue to serve in specific antimicrobial treatments, especially where resistance limits other agents. Their pharmacological profiles depend heavily on the purity and stability of the API.

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API Overview and Specifications

Sulfabenamide

• Chemical Class: Sulfonamide antibacterial
• CAS Number: 698-09-9
• Uses: Historically utilized as an antimicrobial agent, now mainly as a chemical intermediate or research reagent

Sulfacetamide

• Chemical Class: Sulfonamide antibiotic
• CAS Number: 68-33-9
• Uses: Commonly used topically to treat bacterial conjunctivitis, rosacea, and skin infections

Sulfathiazole

• Chemical Class: Thiazole sulfonamide
• CAS Number: 68-35-5
• Uses: Utilized primarily for intestinal infections as an oral antimicrobial

Because of their age and specific usage profiles, the sourcing of these APIs is relatively mature but can vary depending on market demand and regional manufacturing capabilities.

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Global API Suppliers for Triple Sulfa Compounds

1. China

China remains the dominant supplier for bulk API production, including sulfa compounds, driven by large-scale manufacturing and lower production costs. Leading Chinese API producers include:

• North China Pharmaceutical Group Corporation (NCPC): Known for synthesizing and exporting a broad range of sulfa APIs, including Sulfacetamide and Sulfathiazole, meeting rigorous quality standards (e.g., GMP compliance).
• Jiangsu Hengrui Medicine Co., Ltd.: Provides bulk sulfa APIs for generic formulations, with extensive research and development capabilities.
• Zhejiang Huahai Pharmaceutical Co., Ltd.: Recognized for producing high-purity sulfa APIs for export and domestic markets.

2. India

India is a significant hub for pharmaceutical intermediates and bulk APIs:

• Gents Pharmaceuticals: Supplies Sulfathiazole and related sulfa APIs, certified under GMP and ISO standards, catering primarily to generic markets.
• VVI Pharmaceuticals: Specializes in sulfonamide APIs, including Sulfacetamide, with export certifications to global markets such as the US and European Union.
• Neelkanth Pharmaceuticals: Offers custom synthesis and bulk supply of Sulfabenamide and other sulfa compounds.

3. Europe and North America

While less dominant in bulk API production, European and North American firms focus on high-quality APIs:

• BASF SE (Germany): Supplies select sulfa APIs with stringent quality and compliance standards, primarily for pharmaceutical manufacturers in Europe.
• Sigma-Aldrich (USA): Provides research-grade sulfonamides, including Sulfacetamide, suitable for lab and small-scale pharmaceutical production.
• Evonik Industries (Germany): Offers specialty sulfa intermediates, adhering to pharmaceutical-grade standards.

4. Other Notable Sources

• Akorn Pharmaceuticals (USA): As a manufacturer of finished dosage forms, may also source APIs through strategic partnerships with bulk suppliers.
• Shaanxi Top Pharm Co., Ltd. (China): Active in synthesizing and exporting sulfa APIs, including Sulfabenamide.

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Regulatory and Quality Considerations

For pharmaceutical manufacturing, API purity, batch-to-batch consistency, and compliance with cGMP are critical. The following factors influence sourcing decisions:

• Regulatory approvals: Suppliers with FDA, EMA, or equivalent certifications are preferred.
• Purity standards: API specifications must meet pharmacopeia standards (USP, EP).
• Supply stability: Long-term supply agreements minimize risks of shortages.
• Pricing and lead times: Cost competitiveness combined with reliable delivery schedules influence supplier selection.

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Emerging Trends and Challenges

• Shift towards sustainable synthesis: Suppliers integrating environmentally friendly processes are gaining favor.
• Regional regulations: Evolving policies impact API manufacturing and export permissions.
• Market demand variability: Increased regulatory scrutiny on older antibiotics may influence procurement volumes.
• Counterfeit risks: Ensuring authenticity through traceability and certification remains vital.

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Conclusion

The procurement of bulk APIs for triple sulfa compounds involves a geographically diverse supply network predominantly centered in China and India, with high-quality suppliers in Europe and North America supplementing global sourcing. Maintaining quality, regulatory compliance, and supply stability remains paramount. Strategic partnerships with reputable API manufacturers ensure pharmaceutical companies can reliably produce effective sulfa-based antimicrobial agents.

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Key Takeaways

• China and India are primary sources for Sulfabenamide, Sulfacetamide, and Sulfathiazole, with a growing emphasis on GMP-certified suppliers.
• European and North American suppliers provide higher-cost, high-quality APIs suitable for regulated markets.
• Regulatory compliance, purity standards, and supply stability are critical factors influencing API sourcing decisions.
• Emerging sustainability initiatives may shift supplier preferences towards environmentally friendly manufacturing.
• Continuous monitoring of geopolitical and regulatory changes is necessary to mitigate supply chain risks.

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FAQs

Q1: Are there synthetic alternatives to natural sources for these APIs?
A: Yes, chemical synthesis processes for sulfa APIs are well-established, allowing for large-scale, consistent production without dependence on natural sources.

Q2: How do regulatory standards impact API sourcing for triple sulfa compounds?
A: Suppliers must meet cGMP standards and provide certificates of analysis aligning with pharmacopeia requirements to ensure compliance and market acceptance.

Q3: Is there increasing demand for these older sulfa APIs?
A: While newer antibiotics have supplanted some older sulfa drugs, specific indications and resistance profiles sustain niche demand, primarily in generic markets.

Q4: Can startups access affordable sulfur-based APIs?
A: Yes, through established suppliers in China and India, but thorough quality assessment and regulatory due diligence are essential.

Q5: What are the primary factors for choosing between supplier regions?
A: Cost, regulatory compliance, API quality, supply reliability, and geopolitical stability influence regional supplier selection.

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References

1. United States Pharmacopeia (USP). [Online] Available at: https://www.usp.org
2. European Pharmacopoeia (EP). [Online] Available at: https://www.edqm.eu
3. Global API Market Reports. MarketWatch, 2022.
4. Industry supplier directories: PharmaSources, ChemSpider.
5. Market-specific regulatory guidelines: FDA, EMA publications.