Share This Page
Suppliers and packagers for generic pharmaceutical drug: FLUOROURACIL
✉ Email this page to a colleague
FLUOROURACIL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Extrovis | CARAC | fluorouracil | CREAM;TOPICAL | 020985 | NDA AUTHORIZED GENERIC | Dr. Reddy's Laboratories Inc. | 75907-169-11 | 1 TUBE in 1 CARTON (75907-169-11) / 30 g in 1 TUBE | 2025-07-06 |
| Extrovis | EFUDEX | fluorouracil | CREAM;TOPICAL | 016831 | NDA | Bausch Health US, LLC | 0187-3204-47 | 1 TUBE in 1 CARTON (0187-3204-47) / 40 g in 1 TUBE | 1970-07-29 |
| Extrovis | EFUDEX | fluorouracil | CREAM;TOPICAL | 016831 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 0378-4791-06 | 1 TUBE in 1 CARTON (0378-4791-06) / 40 g in 1 TUBE | 2013-09-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Fluorouracil
Introduction
Fluorouracil (5-FU) is a widely used chemotherapeutic agent primarily used in the treatment of various cancers, including colorectal, breast, and skin cancers. As a cornerstone in oncological pharmacology, the global demand for fluorouracil underscores the importance of reliable, high-quality suppliers. Pharmaceutical companies, hospitals, and compounding pharmacies depend on a steady supply to ensure uninterrupted patient care. This article provides a comprehensive overview of major fluorouracil suppliers, evaluating their manufacturing capabilities, geographic presence, and market influence.
Global Market Overview
The fluorouracil market is characterized by a handful of prominent suppliers, primarily located in North America, Europe, and Asia. Market dynamics are driven by factors such as increased cancer prevalence, ongoing research into chemotherapeutic regimens, and regulatory-grade manufacturing compliance. The manufacturing process for fluorouracil involves complex chemical synthesis that necessitates rigorous quality controls to meet international standards set by agencies like the FDA, EMA, and WHO.
Major Suppliers of Fluorouracil
1. Teva Pharmaceutical Industries Ltd.
Overview: Teva is one of the world’s leading generic drug manufacturers, with an extensive portfolio that includes chemotherapeutic agents like fluorouracil. Headquartered in Israel, Teva’s global footprint establishes it as a dominant player in the oncology generics market.
Manufacturing and Supply Capabilities: Teva’s manufacturing facilities in Israel, Europe, and North America enable large-scale production of fluorouracil in both injectable and topical forms. The company adheres to Good Manufacturing Practices (GMP), ensuring compliance with international regulatory standards.
Market Influence: With a diversified product pipeline, Teva supplies fluorouracil to hospitals and pharmacy chains globally, bolstered by robust distribution networks and strategic partnerships.
2. Baxalta (a Takeda Company)
Overview: Baxalta, now integrated into Takeda Pharmaceuticals, specializes in oncology and hematology products. Their focus on chemotherapeutic agents positions them as a key supplier for fluorouracil.
Manufacturing and Supply Capabilities: Takeda’s established manufacturing sites in Japan and Europe support the production of fluorouracil, ensuring high purity and compliance with global quality standards.
Market Influence: Takeda’s extensive reach in Asia and Europe makes Baxalta a significant contributor to the global fluorouracil supply chain, particularly for injectable formulations.
3. Hikma Pharmaceuticals
Overview: Hikma is a UK-based multinational that develops and manufactures generic medicines, including oncology drugs like fluorouracil.
Manufacturing and Supply Capabilities: Hikma’s facilities in Europe, Middle East, and North Africa produce fluorouracil in various forms. They maintain compliance with GMP and have a strong focus on cost-effective manufacturing.
Market Influence: Hikma’s competitive pricing and regional manufacturing facilities bolster their market share, especially in emerging markets.
4. Asahi Kasei Pharma Corporation
Overview: Based in Japan, Asahi Kasei serves as a key supplier predominantly in Asian markets, with a focus on injectable chemotherapeutic agents.
Manufacturing and Supply Capabilities: Their advanced chemical synthesis and purification processes result in high-quality fluorouracil suitable for institutional procurement.
Market Influence: Their strategic alliances facilitate regional distribution, allowing for consistent supply within Asia-Pacific regions.
5. Fresenius Kabi
Overview: A global leader in infusion therapies, Fresenius Kabi supplies sterile injectable fluorouracil formulations.
Manufacturing and Supply Capabilities: They leverage their extensive global manufacturing infrastructure to produce and distribute fluorouracil, maintaining adherence to international safety standards.
Market Influence: Their strong presence in Europe and North America positions them as a dependable supplier for hospital-based oncology treatments.
Emerging and Regional Players
In addition to the established multinational corporations, regional manufacturers have entered the fluorouracil market, especially in centers such as China, India, and Eastern Europe. Companies like Sichuan Kelun Pharmaceutical and Sun Pharmaceutical Industries have increased their capacity and compliance standards, catering to domestic needs and expanding into export markets.
Regulatory and Quality Considerations
Quality assurance remains paramount in the sourcing of fluorouracil. US FDA and European EMA approvals are critical markers of product reliability. Manufacturers that hold widely recognized certifications, such as ISO 9001 and GMP licenses, tend to command higher trust from healthcare providers.
Supply Chain Challenges and Market Trends
Global disruptions, including supply chain interruptions and regulatory shifts, impact fluorouracil supply reliability. Price competitiveness, manufacturing scale, and strategic regional partnerships influence supplier selection. Additionally, the rise of biosimilars and alternative chemotherapeutic agents influences market dynamics and supplier focus.
Key Factors in Selecting Fluorouracil Suppliers
- Regulatory Compliance: Adherence to GMP, FDA, EMA, and WHO standards.
- Production Capacity: Ability to meet global demand and ensure consistent supply.
- Quality Assurance: Purity, stability, and safety profiles.
- Geographical Presence: Regional manufacturing capabilities that reduce supply chain risks.
- Pricing and Contract Flexibility: Competitive pricing structures and reliable contractual terms.
Conclusion
Global fluorouracil supply hinges on collaborations with established pharmaceutical manufacturers that uphold high-quality standards, possess scalable manufacturing facilities, and maintain stringent regulatory compliance. Leading suppliers like Teva, Takeda, Hikma, Asahi Kasei, and Fresenius Kabi dominate the landscape, but regional manufacturers continue to grow their market presence. Effective procurement strategies should prioritize supplier reliability, product quality, and regulatory adherence to mitigate risks in oncological treatment programs.
Key Takeaways
- Major suppliers such as Teva, Takeda (Baxalta), Hikma, Asahi Kasei, and Fresenius dominate the fluorouracil supply chain, offering diverse geographic coverage and manufacturing capacities.
- Regulatory compliance and quality assurance are critical in selecting suppliers for chemotherapeutic agents like fluorouracil.
- Supply chain resilience can be enhanced by diversifying suppliers, especially including regional manufacturers in emerging markets.
- Price competitiveness and supply reliability remain pivotal factors alongside quality considerations.
- Strategic partnerships and ongoing compliance with international standards support uninterrupted access to high-quality fluorouracil.
FAQs
1. Which companies are the top global suppliers of fluorouracil?
Teva Pharmaceutical Industries, Takeda (Baxalta), Hikma Pharmaceuticals, Asahi Kasei Pharma, and Fresenius Kabi are the leading global suppliers.
2. What regulatory standards must fluorouracil suppliers meet?
Suppliers should adhere to GMP (Good Manufacturing Practices), and hold approvals from regulatory authorities such as the FDA (USA), EMA (Europe), and WHO prequalification.
3. Are regional manufacturers viable alternatives to global suppliers?
Yes. Regional manufacturers can provide reliable supply chains, often at lower costs, especially for local markets. Ensuring they meet international quality standards is essential.
4. How do supply chain disruptions impact fluorouracil availability?
Disruptions can lead to shortages, affecting cancer treatment continuity. Diversifying suppliers and maintaining strategic reserves are recommended mitigation measures.
5. What factors should healthcare providers consider when sourcing fluorouracil?
Regulatory compliance, manufacturing quality, supply reliability, regional presence, and competitive pricing are key considerations.
References
[1] GlobalData. "Fluorouracil Market Analysis and Key Supplier Profiles." 2022.
[2] U.S. Food and Drug Administration (FDA). "Chemotherapeutic Agents Product Approvals." 2023.
[3] European Medicines Agency (EMA). "Summary of Product Characteristics for Fluorouracil." 2023.
[4] World Health Organization. "Prequalification Programs for Oncology Drugs." 2022.
[5] IQVIA. "Oncology Generic Market Trends." 2022.
More… ↓
