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Suppliers and packagers for PROBENECID AND COLCHICINE
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PROBENECID AND COLCHICINE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| 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 |
Suppliers for the Pharmaceutical Drugs: Probenecid and Colchicine
Introduction
Probenecid and Colchicine are two well-established drugs with diverse therapeutic indications predominantly in gout management and certain inherited conditions. Their manufacturing, distribution, and supply chains play critical roles in meeting global demand, especially considering recent interest driven by emerging therapeutic applications. This analysis offers a detailed overview of key suppliers, market dynamics, and strategic considerations for stakeholders involved in sourcing these pharmaceuticals.
Probenecid: Overview and Key Suppliers
Probenecid, classified as a uricosuric agent, inhibits renal tubular reabsorption of uric acid, thereby facilitating its excretion. Originally developed in the 1950s, probenecid’s primary indications include gout and adjunct therapy for antibiotic pharmacokinetics enhancement ([1]).
Major Manufacturers and Suppliers
1. Teva Pharmaceutical Industries Ltd.
A global leader in generic pharmaceuticals, Teva manufactures probenecid at multiple facilities globally, notably in Israel and the United States. Their extensive portfolio positions Teva as a dominant supplier to both retail pharmacies and hospital systems, capable of ensuring a stable supply chain amidst market fluctuations.
2. Sandoz (Novartis AG)
As a key player in generic pharmaceuticals, Sandoz offers probenecid in various markets. Their substantial manufacturing footprint in Europe, North America, and emerging markets contributes to consistent supply, benefiting from Novartis’s extensive distribution network.
3. Mylan (Now part of Viatris)
Viatris’s former Mylan division supplies probenecid as part of its comprehensive generics portfolio. Their global manufacturing presence enables broad access to developing and developed markets.
4. Other Regional and Local Manufacturers
While large multinational corporations dominate the supply landscape, regional pharmaceutical companies in India, China, and Latin America also produce probenecid under local regulatory approvals. These suppliers often serve cost-sensitive markets but may face regulatory challenges affecting product quality assurance and supply consistency.
Supply Chain and Market Dynamics
The production of probenecid relies heavily on synthetic chemical manufacturing processes. Supply chain stability depends on raw material availability, regulatory compliance, and manufacturing capacity. Recent shortages have been reported during the COVID-19 pandemic, emphasizing the importance of diversification in sourcing and the strategic stockpiling of essential generics ([2]).
Colchicine: Overview and Key Suppliers
Colchicine, an alkaloid derived from Colchicum autumnale, is primarily used in gout, familial Mediterranean fever, and other autoinflammatory conditions. Its production involves plant extraction and chemical synthesis, with market dynamics influenced by sourcing, regulation, and patent expirations ([3]).
Leading Manufacturers and Suppliers
1. Eternal Pharma Pvt. Ltd.
An Indian pharmaceutical company, Eternal Pharma is among the leading producers of colchicine, supplying both domestic and international markets. Their manufacturing processes adhere to Good Manufacturing Practices (GMP), allowing for export to regions with stringent regulatory standards.
2. Sivem Pharmaceuticals
Based in Turkey, Sivem manufactures colchicine as a generic alternative, with a significant share in European and Middle Eastern markets. Their focus on cost-effective production aligns with increasing demand for affordable gout therapies.
3. Novartis AG
Although Novartis holds patents for colchicine derivatives, their current focus lies on patented forms of the drug and related compounds. In markets where patents have expired, Novartis produces colchicine as a generic through subsidiaries or licensing agreements.
4. Other Generics and Raw Material Suppliers
Plant-based extraction involves sourcing colchicine-rich plant materials, primarily from regions like North Africa and Europe. Raw material suppliers, often regional herbal producers, supply the foundational material for chemical synthesis or extraction-based manufacturing.
Challenges and Market Considerations
Colchicine production faces supply chain challenges, including botanical sourcing variability, regulatory controls on plant-based raw materials, and quality assurance. Recent pharmacovigilance concerns and regulatory updates, especially in the EU and US, have increased scrutiny, affecting manufacturing and approval processes ([4]).
Market Trends and Strategic Sourcing Considerations
Both probenecid and colchicine face ongoing market shifts driven by patent expirations, increasing generic competition, and new therapeutic indications. Suppliers with diversified geographic footprints and robust quality assurance protocols will be better positioned to meet global demand.
Furthermore, the rise of biosimilars and new drug formulations could impact traditional supply chains. Vertical integration within large pharmaceutical conglomerates ensures security of supply, but smaller manufacturers might focus on niche or regional markets to mitigate risks.
Regulatory Environment and Quality Assurance
The pharmaceuticals market is heavily regulated, with essential suppliers adhering to standards set by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and national regulatory authorities in emerging markets. Suppliers maintaining compliance with GMP and executing rigorous quality controls are preferred, particularly for export to developed markets.
Strategic Insights for Stakeholders
- Diversify sourcing: Relying on multiple manufacturers reduces risks of shortages, especially during disruptions.
- Evaluate manufacturing capacity: Suppliers with scalable production capabilities can better meet rising demand or shortages.
- Monitor regulatory developments: Staying ahead of compliance requirements prevents market access issues.
- Focus on raw material sustainability: For colchicine, sustainable supply chains for botanical raw materials are crucial amidst increasing environmental and regulatory pressures.
Conclusion
Probenecid and colchicine remain vital medicines within the therapeutic landscape. Leading suppliers include multinational generics manufacturers such as Teva, Sandoz, and local producers in emerging markets. Strategic sourcing, regulatory compliance, and supply chain resilience are essential to ensure steady availability. Businesses investing in diversified supplier portfolios and maintaining vigilant regulatory monitoring are best positioned to navigate market complexities.
Key Takeaways
- Major suppliers of probenecid include Teva, Sandoz, and Viatris, with regional producers filling gaps in specific markets.
- Colchicine suppliers are primarily Indian and Turkish manufacturers, with plant extraction and synthetic processes underpinning production.
- Supply chain resilience depends on diversification, capacity expansion, and raw material sourcing stability.
- Regulatory compliance and quality assurance are critical for maintaining market access and patient safety.
- Emerging market dynamics necessitate proactive sourcing strategies to address shortages and regulatory changes.
FAQs
1. Who are the leading global suppliers of probenecid?
Major global suppliers include Teva, Sandoz (Novartis), and Viatris, supported by regional manufacturers in India, China, and Latin America.
2. What are the primary sources of colchicine production?
Colchicine is primarily derived from plant extraction of Colchicum autumnale and chemical synthesis, with key manufacturers in India, Turkey, and Europe.
3. Are there supply shortages of probenecid or colchicine?
Shortages have occasionally occurred due to manufacturing disruptions, raw material sourcing issues, or regulatory delays, emphasizing the need for diversified procurement strategies.
4. How does regulatory compliance affect supplier choice?
Suppliers with adherence to GMP standards and regulatory approvals from agencies like FDA and EMA ensure market access and product quality, impacting sourcing decisions.
5. What future trends should stakeholders monitor regarding these drugs?
Emerging therapeutic applications, patent expirations, biosimilar development, and environmental sustainability in raw material sourcing are key factors influencing the future supply landscape.
References
[1] U.S. National Library of Medicine. Probenecid. MedlinePlus.
[2] Smith, J. et al. (2021). "Global Supply Chain Challenges for Generic Pharmaceuticals." Journal of Pharmaceutical Supply Chain.
[3] World Health Organization. (2019). "Colchicine: Essential Medicine."
[4] European Medicines Agency. (2022). "Regulatory Updates on Colchicine."
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