COLCHICINE; PROBENECID: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Watson Labs	COL-PROBENECID	colchicine; probenecid	TABLET;ORAL	084279	ANDA	Actavis Pharma, Inc.	0591-5325-01	100 TABLET in 1 BOTTLE, PLASTIC (0591-5325-01)	1982-10-01
Novast Labs	PROBENECID AND COLCHICINE	colchicine; probenecid	TABLET;ORAL	040618	ANDA	Ingenus Pharmaceuticals, LLC	50742-263-01	100 TABLET in 1 BOTTLE (50742-263-01)	2019-05-16
Rising	PROBENECID AND COLCHICINE	colchicine; probenecid	TABLET;ORAL	217030	ANDA	Rising Pharma Holdings, Inc.	16571-832-01	100 TABLET in 1 CONTAINER (16571-832-01)	2023-10-24
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

In the pharmaceutical landscape, establishing reliable suppliers for active pharmaceutical ingredients (APIs) such as colchicine and probenecid is crucial for manufacturers, healthcare providers, and regulatory compliance. Both drugs serve distinct therapeutic roles—colchicine as an anti-inflammatory agent primarily for gout management, and probenecid as a uricosuric agent used in gout and infectious disease treatments. This article provides a comprehensive overview of the global suppliers for colchicine and probenecid, highlighting market players, manufacturing trends, regulatory considerations, and strategic sourcing insights.

Market Overview and Significance

Colchicine is derived from the colchicum plant and has a long-standing history dating back centuries. Despite its age, recent interest stems from research into its potential applications for other conditions, such as cardiovascular diseases and COVID-19-related inflammatory responses. The drug's narrow therapeutic index also underscores the importance of sourcing from reputable suppliers to ensure safety and efficacy.

Probenecid is primarily used to manage hyperuricemia and facilitate antibiotic therapy via uric acid excretion enhancement. As a generic, its manufacturing and supply chains are highly globalized, often characterized by cost-driven production but with strict regulatory requirements for quality control.

Global Suppliers of Colchicine

Major Players and Manufacturing Regions

Hainan Baozhen Pharmaceutical Co., Ltd. (China)
- A prominent producer specializing in plant-derived alkaloids, including colchicine.
- Supplies primarily to Asian markets but expanding internationally through distributors.
- Known for competitive pricing but faces scrutiny regarding regulatory compliance in some regions.
Rimso-L, Inc. (USA)
- A US-based provider involved in the distribution of colchicine, primarily as an imported product.
- Focuses on North American markets, emphasizing quality standards adherence, including cGMP certifications.
Tianjin Maiwei Biological Pharmacy Co., Ltd. (China)
- Develops and supplies colchicine as part of a broader portfolio of plant-based APIs.
- Certified to international standards, with expanding exports to Europe.
Zhejiang Winhealth Pharmaceutical Co., Ltd. (China)
- Supplies colchicine APIs and finished formulations to various international markets.
- Significant R&D capabilities to ensure product consistency.
Kenya Pharmaceutical Manufacturers Ltd. (Kenya)
- Regional supplier predominantly serving the African continent.
- Focuses on cost-effective sourcing aligned with regional healthcare demands.

Emerging Trends and Supply Chain Dynamics

Manufacturing Concentration in China and India: These regions dominate global API production due to cost advantages and mature pharmaceutical manufacturing infrastructure. Regulatory scrutiny, however, is increasing, prompting some companies to diversify sourcing strategies.
Regulatory Challenges: Suppliers must comply with WHO GMP standards, EMA, and FDA requirements, especially in export markets.
Supply Chain Risks: Dependence on a limited number of producers has prompted initiatives for supply chain diversification to mitigate shortages, particularly amid geopolitical tensions and pandemic disruptions.

Global Suppliers of Probenecid

Key Manufacturers and Market Participants

Shanxi Pioneer Pharmaceutical Co., Ltd. (China)
- A leading manufacturer of probenecid, exporting globally.
- Noted for compliance with international quality standards, including ISO and cGMP.
UQUIFA Pharma (Spain)
- A European-based producer known for high purity probenecid APIs.
- Supplies to both generic and branded medication manufacturers within the European Union.
MMD Laboratories Ltd. (India)
- Supplies bulk probenecid API to global markets, with a focus on cost competitiveness.
- Adheres to stringent quality controls aligned with Indian regulatory agencies.
Jiangsu Hengrui Medicine Co., Ltd. (China)
- Engages in the production of APIs including probenecid under strict quality management systems.
- Invests heavily in process optimization to ensure consistent supply.
Fresenius Kabi (Germany)
- Provides finished formulations and sometimes APIs as part of integrated supply chains.
- Emphasizes compliance with European standards and reliable logistics.

Supply Chain and Market Factors

Manufacturing Concentration and Competition: Multiple Chinese and Indian manufacturers dominate the market with diverse supply capabilities.
Regulatory Compliance: Suppliers increasingly seek certifications like GMP, ISO, and adherence to ICH standards to maintain access to Western markets.
Global Demand Drivers: Rising prevalence of gout and hyperuricemia sustains demand, influencing supply chain stability and investment in manufacturing capacity.

Regulatory and Quality Considerations

Operators sourcing colchicine and probenecid must prioritize regulatory compliance, including:

GMP Certification: Ensures consistent quality and is mandated for API manufacturing intended for global markets.
Supplier Audits: Critical for verifying manufacturing practices, especially given the narrow therapeutic index of colchicine.
Import/Export Regulations: Varying by country, with notable restrictions or documentation requirements in the US (FDA) and EU (EMA).
Traceability and Documentation: Essential for regulatory submissions and pharmacovigilance.

Strategic Sourcing Approaches

Diversification of Suppliers: To mitigate supply risks, companies should cultivate relationships across multiple regions and manufacturers.
Vertical Integration: Some large pharmaceutical firms pursue in-house API manufacturing or exclusive supplier agreements for quality assurance.
Regional Focus: In regions like Africa and Southeast Asia, developing local manufacturing capabilities can reduce dependency on global supply chains.
Blockchain and Digital Traceability: Implementing digital tools can enhance supply chain transparency, improve compliance, and prevent counterfeiting.

Conclusion

Reliable procurement of colchicine and probenecid requires strategic engagement with a diverse set of global suppliers. China and India dominate API manufacturing for both drugs, emphasizing the need for rigorous quality assurance and regulatory compliance. As geopolitical and pandemic-related disruptions persist, diversification, technological adoption, and regional development are critical for maintaining stable supply chains. Businesses should continuously monitor supplier performance, establish robust qualification protocols, and adapt sourcing strategies to ensure consistent access to high-quality APIs.

Key Takeaways

Major suppliers of colchicine and probenecid are concentrated in China and India, forming the backbone of global API supply chains.
Ensuring suppliers hold GMP and other international quality certifications is vital for compliance and safety.
Diversification minimizes risks associated with supply disruptions, regulatory changes, or geopolitical tensions.
Evolving regulatory landscapes and quality standards compel suppliers and purchasers to emphasize transparency, traceability, and rigorous auditing.
Strategic sourcing, regional manufacturing development, and advanced supply chain management strategies are essential for securing consistent drug supply.

FAQs

Q1: What are the primary regions producing colchicine and probenecid APIs?
A: China and India are the leading regions for manufacturing colchicine and probenecid APIs, driven by cost advantages and established pharmaceutical infrastructure.

Q2: How does regulatory compliance impact supplier selection for these drugs?
A: Suppliers must demonstrate adherence to GMP, ISO, and other quality standards to meet stringent regulatory requirements, especially for markets like the US and EU.

Q3: Are there alternative sources for colchicine and probenecid?
A: Yes, some European and American manufacturers produce these APIs, often with higher regulatory compliance standards but at premium costs. Diversification includes regional suppliers in Africa and Southeast Asia.

Q4: What risks are associated with over-reliance on specific suppliers?
A: Over-reliance may lead to supply shortages, quality issues, and regulatory challenges. Diversification helps mitigate these risks.

Q5: What strategic approaches can companies adopt to ensure API supply stability?
A: Companies should diversify suppliers, pursue vertical integration, develop regional manufacturing, and leverage digital traceability systems for improved supply chain transparency.

References

[1] World Health Organization. WHO Good Manufacturing Practices (GMP) Guidelines.
[2] U.S. Food and Drug Administration. Guidance for Industry: Quality Systems Approach to Pharmaceutical Quality Manufacturing.
[3] European Medicines Agency. Guideline on good distribution practices (GDP) for human medicines.
[4] Market reports on global API manufacturing and supply chain trends (2022).
[5] Industry analysis of chromic pharmaceutical APIs, including supplier profiles and regulatory landscape.

Note: This article emphasizes current market dynamics as of 2023, recognizing that the pharmaceutical supply chain landscape is subject to change based on regulatory developments, geopolitical factors, and technological advancements.

Suppliers and packagers for generic pharmaceutical drug: COLCHICINE; PROBENECID