Last updated: July 27, 2025
Introduction
Probenecid is a longstanding pharmaceutical used primarily to manage gout and to prolong the plasma concentration of certain antibiotics, such as penicillin. Its unique pharmacological profile as a uricosuric agent has cemented its role in both clinical and research settings. Identifying reliable suppliers for probenecid is vital for healthcare providers, pharmaceutics companies, and researchers aiming to access high-quality, regulatory-compliant formulations. This comprehensive overview explores the global landscape of probenecid suppliers, highlighting key manufacturers, regulatory considerations, and market trends shaping procurement strategies.
Global Market Overview and Major Suppliers
Probenecid is predominantly supplied by a combination of large international pharmaceutical firms, generic drug manufacturers, and specialized chemical suppliers. The global supply chain is characterized by a fragmented market with both branded and generic options, varying in geographic coverage, regulatory approvals, and manufacturing standards.
Leading Pharmaceutical Manufacturers of Probenecid
Several pharmaceutical companies are recognized for manufacturing and marketing probenecid, either as branded products or under generic labels. These include:
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Sanofi
Sanofi has historically been one of the prominent producers of probenecid. Their product, Benemid, remains a well-established brand in various markets, particularly in North America. Sanofi’s extensive distribution network ensures reliable supply channels for healthcare institutions and pharmacies.
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Teva Pharmaceuticals
A global leader in generics, Teva supplies probenecid under its extensive portfolio of approved generic medications. Their manufacturing facilities adhere to Good Manufacturing Practices (GMP), facilitating international distribution, including North America, Europe, and emerging markets.
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Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe has a significant presence in the Asian market and supplies probenecid in Japan and neighboring regions. Their products comply with local regulatory standards and are often used in clinical research.
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Pfizer
Although primarily focused on other therapeutic areas, Pfizer holds licenses for certain formulations of probenecid in select territories, often leveraging their broad distribution networks.
Generic and Chemical Suppliers
While branded products dominate in specific markets, the global chemical and pharmaceutical raw material market supplies bulk probenecid intermediates and active pharmaceutical ingredients (APIs) to manufacturers worldwide:
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Zhejiang Hisun Pharmaceutical Co., Ltd. (China)
Offers probenecid API with ISO certifications, serving both generic drug manufacturers and custom API producers.
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Hubei Yichang Humanwell Pharmaceutical Co., Ltd. (China)
Supplies high-quality probenecid API for generic formulation manufacturing.
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BASF SE and Evonik Industries (Germany)
These chemical giants produce raw materials that are utilized by pharmaceutical formulators for synthesizing probenecid.
Contract Manufacturing and Custom API Suppliers
Outsourcing production to contract manufacturing organizations (CMOs) has become common, especially in the context of increasing demand for generic medications:
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Lonza
Offers custom production of APIs, including probenecid, with GMP compliance.
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Patheon (Thermo Fisher Scientific)
Provides contract manufacturing services encompassing API synthesis and formulation development.
Regulatory Considerations in Supplier Selection
Procurement decisions must incorporate regulatory compliance, particularly:
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GMP Certification
Ensures the supplier adheres to quality standards mandated by agencies like the FDA, EMA, or PMDA.
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Regulatory Approvals and Dossiers
Suppliers with approved drug master files (DMFs) and registration dossiers simplify market entry and compliance.
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ISO Certifications
Certification such as ISO 9001 demonstrates quality management system adherence.
Market Trends and Impacts on Supplier Choice
The recent surge in generic drug demand, driven by healthcare cost-containment efforts and COVID-19 related research, has expanded the supply base for probenecid. Market consolidations, patent expirations, and the push for biosimilar and generic alternatives have increased the availability of probenecid APIs and finished products. The Asia-Pacific region, notably China and India, has become a significant supplier hub owing to cost advantages and manufacturing scalability.
Supply Chain Challenges and Mitigation Strategies
Global disruptions such as the pandemic, geopolitical tensions, and raw material shortages have impacted supply reliability. To mitigate risks:
- Diversify suppliers across regions to avoid dependence on a single source.
- Prioritize suppliers with validated supply chains and contingency plans.
- Engage with suppliers holding multiple certifications and robust QA processes.
Conclusion
Probenecid's supplier landscape is diverse, spanning multinational pharmaceutical companies, generic drug manufacturers, and chemical API suppliers. Ensuring quality, regulatory compliance, and supply stability is paramount. As the demand for affordable gout and urinary drug therapies persists, market participants must strategically select suppliers aligned with their operational and regulatory needs to secure a continuous, high-quality supply of probenecid.
Key Takeaways
- Leading suppliers include Sanofi (Benemid), Teva, Mitsubishi Tanabe, and Pfizer, with a proliferation of Chinese and Indian API producers expanding the supply base.
- Robust regulatory compliance, including GMP certification and approved dossiers, is crucial for supplier qualification.
- Diversification across regions mitigates risks from supply chain disruptions.
- Contract manufacturing organizations play a vital role in scaling production and customizing formulations.
- Ongoing market growth driven by generics requires proactive supplier engagement to ensure consistent supply.
FAQs
1. Where can I source high-quality probenecid for clinical research?
Regarded API suppliers, especially those with GMP certification such as Zhejiang Hisun or Hubei Yichang Humanwell, are suitable for clinical research-grade material. Confirm their regulatory approval and ensure batch consistency for research applications.
2. Are there regulatory considerations when importing probenecid?
Yes. Importers must verify that suppliers have necessary GMP certifications and that the product complies with local regulatory standards (e.g., FDA, EMA). Import licenses and registration dossiers may be required depending on jurisdiction.
3. Can I buy probenecid directly from chemical suppliers?
Most chemical API suppliers sell to qualified pharmaceutical manufacturers or licensed distributors. Direct purchasing generally involves compliance with stringent licensing and validation procedures.
4. What are the main challenges in sourcing probenecid?
Market shortages, raw material supply disruptions, quality assurance concerns, and regulatory compliance are key challenges. Establishing relationships with reputable suppliers and diversifying supply sources help mitigate these issues.
5. How has the market for probenecid evolved recently?
The global push toward affordable generics and increased clinical research activity fueled by COVID-19 has expanded the supplier base. Asia-Pacific manufacturers have gained prominence, with increased API production capacity and quality standards.
References
- [1] Sanofi official product portfolio.
- [2] Teva Pharmaceuticals API catalog.
- [3] Mitsubishi Tanabe Pharma – Product information.
- [4] API manufacturers in China: Zhejiang Hisun and Hubei Yichang.
- [5] Industry reports on pharmaceutical supply chain dynamics, 2022.
