Suppliers and packagers for XELODA

XELODA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896	NDA	H2-Pharma, LLC	61269-470-60	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61269-470-60)	1998-04-30
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896	NDA	H2-Pharma, LLC	61269-475-12	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61269-475-12)	1998-04-30

Suppliers for the Pharmaceutical Drug: Xeloda

Last updated: July 27, 2025

Introduction

Xeloda (generic name: capecitabine) is an oral chemotherapeutic agent primarily used to treat metastatic colorectal and breast cancers. Developed by Roche and approved by the FDA in 2001, Xeloda’s widespread adoption has fostered a global network of suppliers involved in manufacturing, distribution, and supply chain management. Understanding these suppliers is critical for pharmaceutical companies, healthcare providers, and stakeholders aiming to ensure drug availability, price stability, and regulatory compliance.

This comprehensive analysis explores the key suppliers associated with Xeloda, emphasizing manufacturing sources, supply chain dynamics, and market actors influencing its global accessibility.

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Manufacturers of Xeloda

Original Manufacturer: Roche

Roche Pharmaceuticals is the patent holder and primary manufacturer of Xeloda. As a global pharmaceutical leader, Roche oversees the production process, quality control, and distribution logistics for Xeloda, ensuring compliance with international regulatory standards. Roche’s manufacturing facilities in Europe and North America serve as the core production sites, with integrated quality assurance protocols aligned with its reputation for high standards in oncology drugs.

Generic Manufacturers

Following patent expiration in various jurisdictions—such as the US (2015) and Europe—multiple generic pharmaceutical companies have entered the market to produce capecitabine. These manufacturers operate under licensing agreements, regulatory approvals, or via authorized generics, contributing to price competition and increased drug access.

Key generic suppliers include:

• Mylan (now part of Viatris): One of the largest generic producers, Mylan has obtained approval from regulatory bodies like the FDA and EMA for capecitabine tablets, offering cost-effective alternatives globally.

• Sun Pharmaceutical Industries: An established Indian manufacturer, Sun Pharma produces capecitabine tablets compliant with international standards, supplying both domestic and export markets.

• Cipla: Also based in India, Cipla manufactures capecitabine as part of its oncology portfolio, with distribution channels spanning Asia, Africa, and Latin America.

• Hetero Labs: This Indian manufacturer supplies capecitabine primarily across emerging markets, with a focus on affordability and regulatory adherence.

• Dr. Reddy’s Laboratories: A multinational based in India, active in the production of capecitabine, with a global distribution network.

Additional Suppliers and Contract Manufacturers

Some pharmaceutical companies rely on Contract Manufacturing Organizations (CMOs) to produce capecitabine, especially those seeking to expand supply without large-scale infrastructural investments. These CMOs often have expertise in active pharmaceutical ingredient (API) manufacturing and oral solid dosage form production.

Notably, core API production sites are located in India and China, which dominate the global active pharmaceutical ingredient (API) market due to cost advantages and manufacturing capacity.

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Global Supply Chain Dynamics

Active Pharmaceutical Ingredient (API) sourcing

The API for capecitabine is predominantly synthesized in India and China, regions that possess extensive API manufacturing capabilities. Leading API producers in India include Zhejiang Hisun Pharmaceutical Co. and Dr. Reddy’s, whereas Chinese manufacturers such as Jiangsu Hengrui Medicine Company contribute significantly to API supply.

Formulation and Finished Dose Production

Once the API is synthesized, it is supplied to formulators globally—both original and generic manufacturers—to produce finished tablets. These companies are often integrated or contracted by major pharmaceutical firms to ensure quality, scalability, and regulatory compliance.

Regulatory Approvals and Market Access

The entry of generics hinges on regulatory clearances from authorities such as the FDA, EMA, and other national agencies. The expiration of patents, notably in 2015 in the US, has catalyzed market entry for numerous generic suppliers.

Distribution Channels

Distribution of Xeloda spans healthcare institutions, specialty pharmacies, and wholesalers worldwide. Logistic stability is vital, particularly in emerging markets where infrastructure challenges may complicate supply chains. Regulatory compliance, temperature control, and inventory management are crucial components of supply chain robustness.

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Market Trends and Competitive Landscape

Market Competition

The presence of multiple manufacturers has increased competition, leading to price reductions and wider accessibility. However, regulatory barriers, quality assurance, and patent litigation influence market dynamics.

Pricing and Reimbursement

Generic competition has driven prices down, improving affordability in many regions. Insurance reimbursement policies and national health programs significantly impact market penetration.

Supply Disruptions

Disruptions in API production—due to geopolitical issues, COVID-19 pandemic impacts, or regulatory delays—have occasionally threatened drug availability. Mitigation strategies include establishing diversified supplier networks and preemptive inventory stockpiling.

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Key Players Summarized

Company	Role	Region	Notes
Roche	Original patent holder and manufacturer	Global	Leads production, quality, and distribution
Mylan / Viatris	Generic production	Global	Major generic supplier post-patent expiry
Sun Pharma	Indian manufacturer	Asia, Africa	Cost-effective generics
Cipla	Indian manufacturer	Asia, Africa	Extensive global presence
Hetero Labs	Indian API & formulation	Emerging markets	Focused on affordability
Dr. Reddy’s	Indian API & formulation	Global	Diversified supply network
Zhejiang Hisun & Jiangsu Hengrui	API manufacturing	China	Critical API suppliers

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Conclusion

The supply landscape for Xeloda is characterized by a dominant original manufacturer—Roche—and a proliferating set of generic producers, primarily based in India and China. These manufacturers supply both APIs and finished dosage forms, playing crucial roles in ensuring global drug availability. Supply chain resilience depends on diversified sourcing, regulatory compliance, and strategic inventory management. Companies and healthcare authorities must monitor geopolitical climates and regulatory changes to mitigate disruptions and ensure continuous patient access.

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Key Takeaways

• Dominant supplier: Roche remains the principal manufacturer of Xeloda, controlling core aspects of production and distribution.

• Generic proliferation: Post-patent expiration has led to an extensive network of Indian and Chinese generics, lowering prices and increasing access.

• API sourcing: Indian and Chinese API manufacturers are vital, emphasizing the importance of supply chain diversification.

• Supply chain risks: Disruptions in API production or regulatory delays can impact supply; proactive strategies are essential.

• Market dynamics: Competition, pricing pressures, and regulatory landscapes shape the availability and affordability of Xeloda worldwide.

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FAQs

1. Who are the primary manufacturers of capecitabine, the active ingredient in Xeloda?
The key API producers are based in India and China, including Zhejiang Hisun Pharmaceutical, Jiangsu Hengrui Medicine, Dr. Reddy’s Laboratories, and Zhejiang Hisun Pharmaceutical, providing active ingredients for both patented and generic formulations.

2. Are generic versions of Xeloda as effective as the original?
Yes. Generic capecitabine products are required to meet rigorous bioequivalence and quality standards set by regulatory agencies such as the FDA and EMA, ensuring comparable efficacy and safety.

3. How has patent expiration affected the supply landscape of Xeloda?
Patent expiration has enabled numerous generic manufacturers to enter the market, increasing competition, reducing prices, and expanding access—particularly in low- and middle-income countries.

4. What are common supply chain challenges for Xeloda?
Challenges include API production disruptions, regulatory delays, geopolitical tensions, and logistical issues—exacerbated during crises like COVID-19—potentially causing shortages.

5. How do regulatory approvals impact the supply of Xeloda?
Regulatory approvals are crucial; they determine market entry for generics and can delay or restrict supply if approvals are not secured or are revoked due to compliance issues.

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References

1. U.S. Food and Drug Administration. (2015). Xeloda (capecitabine) Patient Information.
2. European Medicines Agency. (2022). Xeloda Overview and Market Approvals.
3. Roche Pharmaceuticals. (2023). Official Product Documentation.
4. GlobalData Pharma Intelligence Center. (2023). Market Analysis: Capecitabine and Generic Competition.
5. Indian Pharmaceutical Alliance. (2023). API Manufacturing Landscape in Oncology.