Suppliers and packagers for thioguanine

thioguanine

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Waylis Therap	THIOGUANINE	thioguanine	TABLET;ORAL	012429	NDA	Waylis Therapeutics LLC	80725-630-25	1 BOTTLE in 1 CARTON (80725-630-25) / 25 TABLET in 1 BOTTLE	2023-05-15

Suppliers for the Pharmaceutical Drug: Thioguanine

Last updated: July 28, 2025

Introduction

Thioguanine (6-thioguanine, 6-TG) is an immunosuppressive and chemotherapeutic agent used predominantly in the treatment of leukemia, inflammatory bowel disease, and as part of combination therapy regimens for certain cancers. Due to its critical role in oncology and immunology, securing reliable suppliers is vital for pharmaceutical companies, healthcare providers, and compounding pharmacies. This article provides a comprehensive overview of key suppliers of Thioguanine, analyzing manufacturer profiles, sourcing strategies, regulatory considerations, and market dynamics to support informed decision-making in procurement and supply chain management.

Understanding Thioguanine: A Brief Overview

Thioguanine is a purine analog that interferes with DNA and RNA synthesis, exerting cytotoxic and immunosuppressive effects. It is primarily available in oral tablet form, exclusively through licensed pharmaceutical manufacturing channels. Given its narrow therapeutic window and potential for severe adverse effects, stringent quality standards and regulatory compliance are paramount in its procurement.

Global Supplier Landscape

1. Major Pharmaceutical Manufacturers

The primary suppliers of Thioguanine are established pharmaceutical companies with extensive capabilities in active pharmaceutical ingredient (API) manufacturing. These companies supply both finished dosage forms and bulk APIs to global markets.

A. Sanofi

Sanofi, a multinational biopharmaceutical company headquartered in France, is among the leading suppliers of Thioguanine API. The company manufactures and markets Thioguanine in various regions, adhering to stringent Good Manufacturing Practices (GMP). Sanofi’s global reach ensures a reliable supply chain for major markets.

B. Nippon Shinyaku

Japanese pharmaceutical company Nippon Shinyaku produces Thioguanine API, focusing on quality and innovation. The company supplies APIs and finished products primarily within Asia but has expanded its distribution network globally.

C. Teva Pharmaceuticals

Teva, based in Israel, with a substantial portfolio of generic pharmaceuticals, sources Thioguanine API for its generic drug products. Its global manufacturing sites and distribution channels ensure broad availability.

D. Dr. Reddy’s Laboratories

An Indian pharmaceutical giant, Dr. Reddy’s manufactures and supplies Thioguanine APIs primarily for the Asian and emerging markets, leveraging cost-effective manufacturing and a robust supply chain.

E. Other Regional Suppliers and Generics Manufacturers

Numerous regional players—such as India's Cipla, Sun Pharmaceutical Industries, and global generics producers—may source APIs from third-party manufacturers or produce their own, depending on their quality assurance frameworks.

2. API Manufacturers and Raw Material Suppliers

Apart from original manufacturers, several specialized API manufacturers produce Thioguanine APIs, often serving as raw material suppliers to larger pharmaceutical companies.

A. Piramal Enterprises

Piramal possesses manufacturing facilities capable of producing complex APIs, including Thioguanine, serving both domestic and international clients.

B. Zhejiang Hisun Pharmaceutical

An important Chinese API manufacturer that supplies Thioguanine API for regional markets, emphasizing affordability and compliance with Chinese regulatory standards.

C. Other Asian API Suppliers

Additional suppliers in India, China, and Southeast Asia provide Thioguanine APIs, often at lower costs, but quality standards vary. Due diligence is essential to ensure compliance with international GMP standards.

Regulatory and Quality Considerations

Suppliers must adhere to regional and international regulatory standards such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and PMDA (Pharmaceuticals and Medical Devices Agency, Japan). Procuring APIs from suppliers with current GMP certification and validated manufacturing processes is critical to mitigate risks associated with substandard quality, contamination, or supply disruptions.

Certification and Compliance

• GMP Certification: Ensures product quality, safety, and consistency.
• ICH Guidelines: Compliance with International Council for Harmonisation (ICH) standards.
• Regulatory Approvals: Suppliers must hold necessary approvals from relevant health authorities.

Market Dynamics and Supply Chain Challenges

The supply of Thioguanine is influenced by factors such as geopolitical stability, raw material availability, manufacturing capacity, and regulatory changes. Recent global disruptions, such as the COVID-19 pandemic, have highlighted vulnerabilities in supply chains, prompting companies to diversify sources and establish strategic stockpiles.

The relatively niche market for Thioguanine means that competition among suppliers hinges on quality, price, and regulatory compliance. However, global demand remains steady for specific indications like leukemia, requiring stable supply arrangements.

Emerging Trends and Strategic Sourcing

• Vertical Integration: Some pharmaceutical firms are integrating backwards to directly control API manufacturing, reducing dependence on external suppliers.
• Regionalization: Increased focus on regional suppliers to mitigate geopolitical risks.
• Quality Assurance Enhancements: Emphasis on supplier qualification and audits to ensure consistent quality.
• Innovation and Biosynthesis: Exploration of alternative synthetic pathways and biosynthesis methods to enhance supply resilience.

Procurement Strategies

Successful procurement of Thioguanine requires a multi-pronged approach:

• Supplier Due Diligence: Verify GMP compliance, regulatory track record, and manufacturing capacity.
• Quality Agreements: Establish clear quality standards and testing protocols.
• Supply Chain Diversification: Engage multiple accredited suppliers to mitigate risks.
• Long-term Contracts: Negotiate stable pricing and supply commitments with reliable manufacturers.

Conclusion

Securing a dependable supplier network for Thioguanine necessitates thorough vetting of manufacturers’ regulatory compliance, manufacturing quality, and capacity. Major global pharmaceutical companies, regional API producers in Asia, and emerging biosynthesis technologies contribute to a diversified supply landscape. Strategic sourcing, rigorous quality assurance, and proactive risk management are vital to ensure uninterrupted access to this essential therapeutic agent.

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Key Takeaways

• Leading suppliers of Thioguanine include Sanofi, Nippon Shinyaku, Teva, and Dr. Reddy’s, with regional API manufacturers supplementing supply.
• Regulatory compliance and GMP certification are non-negotiable criteria when selecting suppliers.
• Supply chain resilience can be enhanced through diversification, long-term contractual agreements, and supplier audits.
• Emerging manufacturing approaches, such as biosynthesis, may reshape the Thioguanine supply landscape.
• Continuous monitoring of market dynamics and geopolitical factors is essential for maintaining a stable supply chain.

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FAQs

1. Is Thioguanine solely produced by large pharmaceutical companies?
No, while major companies like Sanofi and Nippon Shinyaku produce Thioguanine, numerous regional and generic manufacturers—primarily in Asia—also produce the API, often serving local or niche markets.

2. What regulatory certifications should I look for in a Thioguanine supplier?
GMP certification is essential, alongside compliance with regional regulatory agencies such as the FDA, EMA, or PMDA to ensure product quality and safety.

3. Are there regional differences in Thioguanine supplier quality standards?
Yes, suppliers in developed countries typically adhere to stricter quality standards compared to some emerging markets. Due diligence and qualification processes are critical when sourcing from non-Western suppliers.

4. How has the COVID-19 pandemic impacted Thioguanine supply chains?
Pandemic-related disruptions affected manufacturing and logistics, underscoring the importance of diversification and strategic inventory management to prevent shortages.

5. What future trends could influence Thioguanine supply?
Advances in biosynthesis, regional manufacturing hubs, and regulatory harmonization are expected to shape the future supply landscape for Thioguanine.

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Sources:

1. [1] Sanofi Official Website. Product Portfolio and API Manufacturing Details.
2. [2] Nippon Shinyaku Corporate Brochure. API Production Capabilities.
3. [3] Teva Global API Suppliers. Product Portfolio and Regulatory Certifications.
4. [4] Indian Pharmacopoeia Commission. API Standards and Industry Reports.
5. [5] WHO Essential Medicines List. Thioguanine Indications and Market Data.