Suppliers and packagers for fareston

fareston

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Kyowa Kirin	FARESTON	toremifene citrate	TABLET;ORAL	020497	NDA	Kyowa Kirin, Inc.	42747-327-30	30 TABLET in 1 BOTTLE (42747-327-30)	1997-06-30
Kyowa Kirin	FARESTON	toremifene citrate	TABLET;ORAL	020497	NDA	Kyowa Kirin, Inc.	42747-327-72	7 TABLET in 1 BLISTER PACK (42747-327-72)	1997-06-30

Last updated: July 28, 2025

ppliers for the Pharmaceutical Drug: Fareston

Introduction
Fareston (toremifene citrate) is a selective estrogen receptor modulator (SERM) primarily used in treating metastatic breast cancer in postmenopausal women. As a critical oncological pharmaceutical, its sourcing strategy involves a nuanced landscape of manufacturing entities, regional distributors, and regulatory considerations. Understanding the key suppliers for Fareston is vital for pharmaceutical companies, healthcare providers, and investors aiming for secure, compliant, and cost-effective access to this medication.

Manufacturers of Fareston (Toremifene Citrate)
Central to the supply chain are the original manufacturers and authorized generic producers. Originally developed by Sanofi (formerly Sanofi-Aventis), Fareston was initially marketed under Sanofi’s brand portfolio. Sanofi's role as a patent holder and primary producer established a foundational supply stream. However, patent expiration in certain jurisdictions has opened avenues for generic manufacturers, expanding the pool of suppliers.

Sanofi’s Role as a Primary Supplier
Sanofi has historically been the predominant source of Fareston, leveraging its extensive manufacturing capabilities and global distribution network. The company's facilities compliant with Good Manufacturing Practices (GMP) ensure high-quality standards essential for oncological drugs. Post-patent expiry, Sanofi has continued to supply Fareston in certain markets, maintaining its position as a reliable source for branded medication.

Generic Manufacturers and Market Diversification
Following patent expiration, a range of generic pharmaceutical companies has entered the Fareston supply chain. These include both domestic and international manufacturers, each contributing to a diversified and resilient supply network:

• Teva Pharmaceutical Industries
  As a global leader in generic medicines, Teva is one of the prominent suppliers of toremifene citrate. Its established manufacturing facilities and distribution networks in North America, Europe, and Asia enable broad market coverage. Teva’s adherence to GMP and robust quality assurance programs make it a trusted supplier for healthcare providers seeking cost-effective alternatives.

• Mylan (now part of Viatris)
  Mylan has historically produced generic SERMs, including toremifene citrate, with manufacturing sites compliant with global quality standards. Their extensive distribution channels facilitate access across multiple markets, especially in regions with high demand for breast cancer therapeutics.

• Sun Pharmaceutical Industries
  As a major Indian pharmaceutical manufacturer, Sun Pharma participates in the global sourcing of generic oncology medications. Their capabilities in producing high-volume generics have made them a significant supplier of toremifene citrate in emerging markets.

• Hetero Drugs and Cadila Healthcare
  Indian-based companies Hetero and Cadila also manufacture generic toremifene citrate, contributing to supply diversity, especially for markets in South Asia, Africa, and parts of Latin America.

• Other Regional Players
  Additional regional generic manufacturers in countries such as China, Egypt, and Southeast Asia are increasingly participating in the Fareston supply chain. Their involvement improves regional access but necessitates rigorous supply chain due diligence regarding quality standards.

Manufacturing and Distribution Considerations
The sourcing of Fareston hinges not only on the presence of multiple suppliers but also on the compliance with regulatory standards such as the US FDA, EMA, or other local authorities. Manufacturers with approved ANDAs (Abbreviated New Drug Applications) or equivalent certifications enjoy a competitive edge, ensuring legal market access and trusted product quality.

Supply chain resilience is also affected by geopolitical factors, manufacturing capacities, and regulatory approvals. Recently, supply disruptions caused by pandemic-related logistics issues and geopolitical tensions have underscored the importance of diversified sourcing from multiple authorized manufacturers.

Wholesalers and Distributors
Beyond primary manufacturers, the distribution network comprises major pharmaceutical wholesalers and distributors who procure Fareston in bulk and distribute it to hospitals, clinics, and pharmacies. Notable global distributors include McKesson, Cardinal Health, and AmerisourceBergen. Regional distributors, particularly in emerging markets, also play critical roles.

Regulatory and Patent Context
The patent landscape influences supplier diversity. In the US, the original patent expired around 2009, enabling generic entry. Regulatory approvals for generics require rigorous bioequivalence and quality assessments, which serve as a bottleneck for new suppliers but also open market opportunities.

Emerging Trends and Future Outlook
In recent years, biosimilar and generic manufacturers are increasingly investing in plant capacities for SERMs, including toremifene citrate, driven by rising breast cancer incidences and expanding market access. Partnerships, licensing agreements, and import-export policies will continue shaping the supplier landscape.

Consolidation and Market Competition
The competitive landscape is dynamic with ongoing mergers, such as Viatris’ consolidation of Mylan, and strategic alliances aimed at optimizing production and supply chain efficiencies. The entry of high-capacity manufacturing hubs in Asia, especially India and China, is likely to lower costs and expand supply availability.

Summary of Major Fareston Suppliers	Supplier	Region	Key Attributes	Regulatory Status	Market Focus
Sanofi	Global	Original patent holder	EMA, FDA approved	Developed markets
Teva	Global	Extensive manufacturing	FDA, EMA approved	Global
Viatris (Mylan)	Global	Large-scale generics	Approved in multiple markets	Global
Sun Pharma	India	Cost-effective manufacturing	Regulatory approvals in India, US, Europe	Emerging & developing markets
Hetero, Cadila	India	Volume production	Local and international approvals	Regional supply

Key Takeaways

• Sanofi remains a principal supplier for Fareston, especially where branded access persists.
• A proliferation of generic manufacturers—Teva, Viatris (Mylan), Sun Pharma, and others—has expanded global supply options post-patent expiry.
• Diversification across multiple suppliers mitigates risks associated with supply disruptions, regulatory delays, and geopolitical factors.
• Regulatory approvals are critical; products must adhere to quality standards like GMP and meet bioequivalence criteria for generics.
• Increasing regional manufacturing in emerging markets enhances accessibility and reduces costs, but necessitates supply chain oversight.

Conclusion
The landscape of Fareston suppliers is characterized by a mix of established pharmaceutical giants and regional generic manufacturers. Business decision-makers must prioritize suppliers with robust regulatory compliance, reliable quality assurance, and scalable manufacturing capacities. As the breast cancer treatment landscape evolves with increased demand for SERMs, supplier diversification remains essential to ensure uninterrupted, safe access to Fareston globally.

FAQs

1. Who are the primary manufacturers of Fareston?
   Sanofi was the original developer and primary supplier, with numerous generic manufacturers like Teva, Viatris (formerly Mylan), and Sun Pharma entering the market post-patent expiry.

2. Are there regional differences in Fareston suppliers?
   Yes; while global companies supply developed markets, regional manufacturers in India, China, and emerging economies considerably contribute to local supply, often at lower costs.

3. How can healthcare providers ensure reliable delivery of Fareston?
   By sourcing from approved, GMP-compliant manufacturers and authorized distributors with proven supply chain integrity and regulatory approvals.

4. What impact does patent expiration have on Fareston's supplier landscape?
   It opens markets to generic manufacturers, increasing supply options and reducing prices but also necessitating due diligence to ensure product quality.

5. What future trends could influence Fareston suppliers?
   Market expansion in developing countries, increased manufacturing capacities in Asia, and strategic alliances among pharmaceutical companies are likely to further diversify and stabilize the supply chain.

References
[1] Sanofi Official Website, Product Portfolio.
[2] FDA Drug Approvals and ANDA Database.
[3] Teva Pharmaceutical Industry Profile, 2022.
[4] Viatris Corporate Overview.
[5] Sun Pharma Annual Report, 2023.