Suppliers and packagers for COL-PROBENECID

COL-PROBENECID

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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

Suppliers for the Pharmaceutical Drug: Col-probenecid

Last updated: August 4, 2025

Introduction

Probenecid, commonly known under commercial names such as Col-probenecid, is a longstanding drug used to treat gout and facilitate the excretion of certain antibiotics by inhibiting renal tubular reabsorption. As a uricosuric agent, its demand persists in clinical settings, augmented by ongoing research into its potential applications. For pharmaceutical companies, healthcare providers, and distributors, understanding the landscape of suppliers providing Col-probenecid is critical to meeting market demands, ensuring drug quality, and optimizing supply chain operations.

This comprehensive overview delineates the major suppliers of Col-probenecid, analyzing their manufacturing capacities, geographical distribution, regulatory standings, and recent market trends. It aims to provide stakeholders with strategic insights into sourcing options, risk management, and opportunities for partnership.

Manufacturers of Col-probenecid

1. Major Pharmaceutical Companies

a. Teva Pharmaceuticals

Overview:
Teva Pharmaceuticals is a prominent global generic and specialty medication manufacturer based in Israel. The company offers a variety of generic drugs, including Col-probenecid, leveraging extensive manufacturing facilities and a robust distribution network.

Supply Capabilities:
Teva’s manufacturing facilities are compliant with Good Manufacturing Practice (GMP) standards, ensuring high quality and consistent supply. They supply Col-probenecid to North America, Europe, and other markets.

Regulatory Compliance:
Teva’s generics typically undergo approval processes through the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency). Their products often hold necessary filings and approvals, facilitating rapid distribution.

b. Sandoz (Novartis)

Overview:
A division of Novartis, Sandoz specializes in producing high-quality generics and biosimilars. Sandoz manufactures Col-probenecid for multiple markets, especially in North America and Europe.

Supply Capabilities:
Sandoz’s manufacturing centers are strategically located, with stringent quality control regimes. They provide both branded and authorized generic versions.

Regulatory Compliance:
Sandoz’s products are extensively reviewed by relevant authorities, allowing for streamlined market entry across regions.

c. Mylan (Now part of Viatris)

Overview:
Mylan, recently merged with Pfizer’s Upjohn unit into Viatris, offers a broad portfolio of generic pharmaceuticals including Col-probenecid.

Supply Capabilities:
Global manufacturing footprint spans North America, Europe, and Asia, matching regional demand. Their production adheres to GMP standards, ensuring reliable supply.

Regulatory Compliance:
Viatris maintains robust approval statuses worldwide, facilitating timely sourcing of Col-probenecid for various markets.

2. Regional and Local Manufacturers

Numerous regional pharmaceutical firms, especially in Asia, produce Col-probenecid to serve local markets. Countries such as India, China, and South Korea have emerging generics manufacturers offering competitive prices.

a. India:
Indian pharmaceutical companies like Zydus Cadila, Lupin, and Sun Pharma produce generic Col-probenecid for both domestic and export markets. Their advantages include cost-effective manufacturing and flexible supply chains.

b. China:
Chinese firms such as Shanghai Pharmaceuticals and North China Pharmaceutical Group produce Col-probenecid, primarily for Asian markets, with increasing quality standards aligning with international regulations.

3. Contract Manufacturing Organizations (CMOs)

Some pharmaceutical companies outsource production of Col-probenecid to CMOs that specialize in active pharmaceutical ingredient (API) synthesis and finished dosage forms. These CMOs include processes complying with international GMP standards and supply agreements tailored to client specifications.

Regulatory Environment and Quality Assurance

Suppliers must conform to stringent regulatory standards, including:

• FDA approval: For the U.S. market, suppliers need to comply with FDA’s Current Good Manufacturing Practice (cGMP) regulations.
• EMA approval: European suppliers require EMA certification.
• Japanese and other Asian regulators: Suppliers targeting Asian markets often seek approval from respective health authorities.

Ensuring supplier compliance minimizes risks of contamination, recalls, and regulatory restrictions. Certification by international agencies or third-party quality audits adds to supplier credibility.

Market Trends and Supply Chain Considerations

a. Demand Dynamics

The global prevalence of gout and infections treated with antibiotics involving Probenecid sustains steady demand. Moreover, research into novel applications (e.g., neuroprotection, cardiology) could influence future procurement priorities.

b. Price Competition

Regional producers in India and China often offer lower prices, which is advantageous for cost-sensitive markets but may raise concerns about quality and regulatory compliance.

c. Supply Chain Risks

Recent disruptions such as the COVID-19 pandemic highlighted vulnerabilities in global API supply chains. Diversifying sourcing options across multiple suppliers and regions mitigates risks of shortages.

d. Regulatory Harmonization

Global harmonization efforts, such as the ICH guidelines, streamline approval processes and facilitate cross-border supply chains. Suppliers with filings in multiple jurisdictions reduce time-to-market for imported drugs.

Key Factors in Supplier Selection

• Regulatory compliance: Ensure suppliers meet local and international standards.
• Quality assurance: Verify certifications, inspection records, and batch consistency.
• Manufacturing capacity: Match supply volumes with demand forecasts.
• Pricing and contracts: Negotiate favorable terms aligned with market competitiveness.
• Geographical considerations: Balance costs with geopolitical stability and logistical efficiency.

Conclusion

The global landscape for Col-probenecid suppliers involves a mix of established multi-national manufacturers and regional players. Leading companies such as Teva, Sandoz, and Viatris maintain high standards of production, regulatory compliance, and supply reliability. Regional producers, especially from India and China, offer competitive alternatives that are increasingly meeting international regulatory benchmarks.

For industry stakeholders, sourcing strategies should integrate diversification, stringent quality oversight, and an understanding of regional regulatory environments. The ongoing evolution of generics manufacturing, coupled with technological innovations and supply chain resilience, promises a stable supply of Col-probenecid in the coming years.

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Key Takeaways

• Major suppliers include Teva, Sandoz, and Viatris, with manufacturing facilities compliant with GMP standards across various regions.
• Regional manufacturers, particularly in India and China, provide cost-effective sourcing options, but require thorough validation of quality standards.
• Regulatory compliance remains paramount; suppliers with approvals from FDA, EMA, and other authorities offer more reliable supply chains.
• Supply chain resilience can be bolstered by supplier diversification and leveraging CMOs with proven GMP certification.
• Market trends suggest sustained demand, with emerging research possibly expanding application areas, emphasizing the importance of reliable sourcing.

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FAQs

1. How can I verify the quality of Col-probenecid supplied by regional manufacturers?
Auditing suppliers for GMP compliance, requesting certification documents, and reviewing prior inspection reports ensure product quality and adherence to regulatory standards.

2. Are generic versions of Col-probenecid equivalent to branded products?
Yes, generics must demonstrate bioequivalence to the original branded formulations, fulfilling regulatory requirements to ensure efficacy and safety.

3. What are the major regulatory hurdles for importing Col-probenecid?
Approval processes vary by country but generally require demonstration of manufacturing quality, safety, and efficacy, with documentation such as Drug Master Files (DMFs) and Certificate of Pharmaceutical Product (CPP).

4. Can regional suppliers meet the global demand for Col-probenecid?
Large regional manufacturers with adequate capacity and certification can meet global demand, especially with diversified supply agreements and scalable production.

5. What factors should I consider when choosing between an international and regional supplier?
Consider regulatory approval status, cost, lead times, manufacturing capacity, quality assurance measures, and geopolitical stability.

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Sources:
[1] U.S. Food and Drug Administration (FDA) database, 2022.
[2] European Medicines Agency (EMA) approvals, 2022.
[3] Company websites of Teva, Sandoz, Mylan, and Indian manufacturers.
[4] Market research reports on the global generic pharmaceutical industry, 2022.