Suppliers and packagers for generic pharmaceutical drug: COLCHICINE

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
Annora Pharma	COLCHICINE	colchicine	CAPSULE;ORAL	217620	ANDA	Camber Pharmaceuticals, Inc.	31722-099-01	100 CAPSULE in 1 BOTTLE (31722-099-01)	2024-04-29
Annora Pharma	COLCHICINE	colchicine	CAPSULE;ORAL	217620	ANDA	Camber Pharmaceuticals, Inc.	31722-099-10	1000 CAPSULE in 1 BOTTLE (31722-099-10)	2024-04-29
Annora Pharma	COLCHICINE	colchicine	CAPSULE;ORAL	217620	ANDA	Camber Pharmaceuticals, Inc.	31722-099-30	30 CAPSULE in 1 BOTTLE (31722-099-30)	2024-04-29
Aurobindo Pharma Ltd	COLCHICINE	colchicine	CAPSULE;ORAL	215463	ANDA	Aurobindo Pharma Limited	59651-446-01	100 CAPSULE in 1 BOTTLE (59651-446-01)	2024-04-29
Aurobindo Pharma Ltd	COLCHICINE	colchicine	CAPSULE;ORAL	215463	ANDA	Aurobindo Pharma Limited	59651-446-30	30 CAPSULE in 1 BOTTLE (59651-446-30)	2024-04-29

Suppliers for the Pharmaceutical Drug: Colchicine

Last updated: July 29, 2025

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Introduction

Colchicine remains a critical pharmacological agent primarily used to treat gout, familial Mediterranean fever (FMF), and certain pericardial conditions. Its unique mechanism of action, targeting microtubule formation, has sustained its clinical relevance despite the emergence of newer therapies. The global supply chain of colchicine is a complex network comprising raw material providers, chemical manufacturers, and finished drug producers. Understanding the landscape of suppliers involved is fundamental for stakeholders including pharmaceutical companies, healthcare providers, and policymakers aiming for continuity of supply, regulatory compliance, and cost optimization.

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Manufacturers and Suppliers of Colchicine Active Pharmaceutical Ingredient (API)

The production of pharmaceutical-grade colchicine primarily depends on specialized chemical companies capable of synthesizing or extracting the active ingredient with high purity standards (Good Manufacturing Practice, GMP). These suppliers serve as the backbone to pharmaceutical firms that transform APIs into finished dosage forms.

1. Chinese and Indian Manufacturers

Leading the global API manufacturing sector are Chinese and Indian companies, given their extensive chemical manufacturing infrastructure and cost advantages. These regions dominate API production, including colchicine.

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China): A prominent supplier offering bulk colchicine API to multiple markets. Its APIs are compliant with international standards, including United States Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur.).

• Aurobindo Pharma Limited (India): Recognized as a major geopolymaker in the generic pharmaceutical industry; supplies colchicine API to global markets, with a focus on stringent quality assurance and GMP compliance.

• Sandoz (Novartis division, India): Has a history of supplying various APIs, including colchicine, with a focus on consistency and regulatory adherence.

2. European and North American Synthetic Chemical Suppliers

While less dominant, certain European and North American companies focus on niche chemicals, including APIs like colchicine, emphasizing strict quality standards and regulatory track records.

• Excelsa Pharma (France): A specialty chemical manufacturer providing high-quality colchicine APIs, primarily for European markets.

• Hoffmann-La Roche (Switzerland): Historically involved in colchicine production; however, its role as a direct API supplier has diminished, with production now primarily in Asian facilities.

3. Extraction and Natural Sources

Historically, colchicine was derived from Colchicum autumnale (autumn crocus) bulbs. While most of today's supply relies on chemical synthesis, a limited number of botanical extractors still operate, providing natural or semi-synthetic colchicine extracts mainly for research purposes.

• European Botanical Extract Producers: Some European suppliers harvest Colchicum species for research-grade colchicine, but commercial pharmaceutical-grade production relies predominantly on chemical synthesis.

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Key Manufacturers for Finished Dosage Forms

Pharmaceutical companies that commission or produce finished colchicine tablets are geographically dispersed, often sourcing API from Asian manufacturers.

1. Global Generic Manufacturers

• Teva Pharmaceutical Industries (Israel): Offers generic colchicine tablets and often sources API globally, adhering to GMP standards.

• Mylan (U.S.): Supplies colchicine formulations, with API sourced predominantly from Asian API producers.

• Hospira (Pfizer): Previously involved in colchicine formulations, now integrated into Pfizer’s broader portfolio, sourcing APIs from compliant manufacturing sites.

2. Regional and Market-Specific Suppliers

• India’s Cipla and Sun Pharma: Both maintain production lines for colchicine tablets, sourcing APIs from their extensive Asian supply chains.

• Chinese Generics Firms: Several Chinese companies produce finished colchicine formulations for domestic and export markets, often sourcing API from local producers.

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Supply Chain Challenges and Considerations

Regulatory Compliance and Quality Assurance

Given the narrow therapeutic index of colchicine and regulatory scrutiny, suppliers must meet stringent quality standards in API production, including adherence to GMP and certification by agencies like the FDA, EMA, or WHO PQ (Prequalification). Disruptions in manufacturing, particularly from suppliers in China and India, can cause worldwide shortages.

Manufacturing Consolidation and Regulatory Changes

Recent trends include manufacturing consolidations among key suppliers and increased regulatory oversight, particularly after quality issues prompted recalls or bans (e.g., Chinese API producers facing enhanced scrutiny post-2019). These factors influence supply stability and pricing.

Impact of Geopolitical and Trade Dynamics

Trade tensions, tariffs, and export restrictions can affect supply availability and costs. For example, restrictions on raw material exports or heightened customs inspections can delay shipments.

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Market Dynamics and Future Outlook

The global colchicine market is expected to evolve with increased interest in biosimilar and botanical alternatives, though synthesizing high-purity colchicine remains key. Manufacturers investing in process innovation and quality systems will shape the supply chain's resilience.

Additionally, the push toward local manufacturing in regions like North America and Europe aims to diversify sourcing options, reduce dependency on Asian suppliers, and mitigate geopolitical risks.

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Regulatory and Certification Impact

Suppliers must ensure compliance with international standards such as USP, Ph. Eur., and the International Organization for Standardization (ISO). Regulatory authorizations (e.g., FDA approval for ingredients or finished drug products) are often prerequisites for supply contracts, particularly in the highly regulated pharmaceutical markets.

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Conclusion

The supply chain of colchicine is predominantly driven by Asian chemical manufacturers, notably in China and India, with European and North American firms playing complementary roles. Pharmaceutical companies seeking reliable sources must prioritize suppliers’ GMP compliance, regulatory track record, and supply chain stability.

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Key Takeaways

• Market Concentration: Asian manufacturers, especially in China and India, dominate the API supply for colchicine, creating reliance risks and emphasizing the importance of supplier diversification.
• Quality and Compliance: Regulatory adherence remains critical, with suppliers needing certifications such as GMP, USP, and EMA approval to meet global standards.
• Supply Chain Vulnerabilities: Recent geopolitical tensions and quality concerns have highlighted the need for strategic sourcing, stockpiling, and alternative suppliers.
• Emerging Trends: Manufacturers are investing in process improvements and local production to enhance supply resilience.
• Regulatory Oversight: Increased scrutiny and evolving standards necessitate ongoing supplier assessment and validation.

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FAQs

1. Who are the major global suppliers of colchicine API?
Major suppliers include Zhejiang Hisun Pharmaceutical (China), Aurobindo Pharma (India), and Sandoz (India), all capable of producing high-quality, GMP-compliant colchicine APIs.

2. Are there any significant regional differences in colchicine suppliers?
Yes, most Asian countries dominate API production, while European and North American firms primarily focus on finished formulations, often sourcing APIs externally.

3. How does regulatory compliance affect colchicine supply?
Regulatory standards such as GMP, USP, and EMA certifications ensure quality and safety, directly impacting supplier eligibility, market access, and supply stability.

4. What challenges threaten colchicine supply chain continuity?
Challenges include geopolitical tensions, quality compliance issues, manufacturing disruptions, and raw material shortages, all of which can lead to shortages or increased costs.

5. Are botanical sources still used for colchicine production?
While historical origins are from Colchicum species, most commercial production relies on synthetic methods; botanical extracts are mainly for research rather than pharmaceutical supply.

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References

1. U.S. Pharmacopeia. Colchicine Monograph.
2. European Pharmacopoeia. Colchicine Specifications.
3. Market reports on API manufacturing in China and India.
4. Regulatory agency publications on pharmaceutical supply chain monitoring.
5. Industry analyses on global drug supply chain resilience.

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Note: This analysis is based on publicly available industry data, regulatory filings, and market observations as of 2023.