Share This Page
Suppliers and packagers for generic pharmaceutical drug: cytarabine; daunorubicin
✉ Email this page to a colleague
cytarabine; daunorubicin
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Jazz Pharms Therap | VYXEOS | cytarabine; daunorubicin | POWDER;INTRAVENOUS | 209401 | NDA | Jazz Pharmaceuticals, Inc. | 68727-745-01 | 20 mL in 1 VIAL (68727-745-01) | 2017-08-03 |
| Jazz Pharms Therap | VYXEOS | cytarabine; daunorubicin | POWDER;INTRAVENOUS | 209401 | NDA | Jazz Pharmaceuticals, Inc. | 68727-745-02 | 40 mL in 1 CARTON (68727-745-02) | 2017-08-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drugs: Cytarabine and Daunorubicin
Introduction
Cytarabine and Daunorubicin are critical chemotherapeutic agents extensively used in oncology, particularly for the treatment of acute myeloid leukemia (AML). Their global demand necessitates a robust supply chain comprised of diverse manufacturers, both branded and generic. This article provides an in-depth overview of the leading suppliers of these drugs, including their manufacturing capabilities, geographical distribution, and market presence, enabling healthcare providers and industry stakeholders to make informed procurement decisions.
Cytarabine: Overview and Leading Suppliers
Overview of Cytarabine
Cytarabine (Ara-C) is an antimetabolite that interferes with DNA synthesis, primarily used in leukemia treatment. Since its development, it has been a staple in chemotherapy protocols, leading to widespread manufacturing and distribution.
Major Suppliers of Cytarabine
1. Pfizer Inc. (Pfizer Oncology)
- Market Presence: As the original developer, Pfizer supplies licensed Cytarabine formulations under the brand DepoCyt. They produce high-quality injections conforming to strict regulatory standards.
- Manufacturing Capabilities: Facilities in the United States and Europe enable consistent supply.
2. Teva Pharmaceutical Industries Ltd.
- Role in Generics: Teva is a leading global producer of generic cytarabine, offering cost-effective alternatives for hospitals and clinics worldwide.
- Manufacturing Footprint: Multiple manufacturing sites in Israel, Europe, and North America facilitate global distribution.
3. Apollo Pharmaceutical
- Regional Provider: Based in India, Apollo produces both licensed and generic cytarabine formulations, catering primarily to the Asian and African markets.
- Quality Standards: Complies with international standards such as WHO-GMP.
4. Hikma Pharmaceuticals
- Global Distribution: Hikma manufactures generic cytarabine, supplying multiple markets globally, especially in Europe, Middle East, and North Africa.
- Production Sites: Facilities in the UK and Middle East ensure reliable production.
5. Sun Pharma
- Emerging Player: A significant Indian generics manufacturer that produces cytarabine for regional markets, with growing penetration in Europe and the US.
Additional Sources and Market Trends:
According to GlobalData, the Cytarabine market is characterized by the dominance of generic manufacturers due to patent expiry of brand-name formulations. The competitive landscape emphasizes affordability and supply reliability, especially in low-resource settings [1].
Daunorubicin: Overview and Leading Suppliers
Overview of Daunorubicin
Daunorubicin is an anthracycline antibiotic that intercalates DNA strands, disrupting synthesis and repair, and is pivotal in AML therapy. Similar to Cytarabine, its market comprises branded and generic products.
Major Suppliers of Daunorubicin
1. Pfizer Inc.
- Market Leadership: Pfizer's DaunoXome has historically been a prominent formulation, although DaunoXome is a liposomal formulation distinct from conventional daunorubicin. The company continues to supply standard daunorubicin in various markets.
- Manufacturing Base: Facilities in the US and Europe ensure adherence to international quality standards.
2. Teva Pharmaceutical Industries Ltd.
- Generic Dominance: Teva supplies generic daunorubicin, distributed globally, especially in emerging markets. Their manufacturing capacity allows for large-volume production.
3. Sandoz (Novartis AG)
- Generic Provider: Sandoz produces daunorubicin as part of their oncology generics portfolio, addressing markets in Europe and North America.
4. Sun Pharma
- Regional Focus: Sun Pharma manufactures daunorubicin for Indian, Southeast Asian, and Middle Eastern markets, emphasizing affordability.
5. Hospira (Pfizer's Biosciences Group)
- Product Range: Hospira offers daunorubicin formulations, mainly focusing on hospital use in the US.
Market Dynamics:
The daunorubicin market is increasingly competitive with several generic manufacturers. Patent expirations and biosimilar developments are expected to influence supply chains and pricing strategies in the coming years [2].
Regulatory Considerations and Supply Chain Stability
Ensuring drug supply stability involves navigating complex regulatory landscapes such as FDA approvals, EMA certifications, and WHO prequalification. Manufacturers meeting Good Manufacturing Practice (GMP) standards are prioritized globally.
Regional import-export policies, especially in light of recent pandemic disruptions, significantly impact availability and pricing. The rise of regional manufacturing hubs in India, China, and Southeast Asia has made supply chains more resilient, but geopolitical factors can still influence distribution pathways [3].
Emerging Trends and Future Outlook
- Biosimilars and Generics: Increasing number of biosimilar entrants for anthracyclines like daunorubicin are expected to enhance affordability and supply security.
- Manufacturing Innovation: Adoption of continuous manufacturing processes improves scalability and quality.
- Supply Chain Diversification: Companies are expanding manufacturing sites to mitigate risks posed by geopolitical or health crises.
Conclusion
The supply landscape for Cytarabine and Daunorubicin features a mix of legacy brand manufacturers and a vibrant generic sector. Key players such as Pfizer and Teva dominate both markets, offering reliable supply channels. However, regional manufacturers, especially from India and Israel, play vital roles in meeting global demand, often at reduced costs—an essential factor for resource-limited healthcare settings. Staying informed on manufacturing capacities, regulatory approvals, and market trends is critical for stakeholders aiming to ensure consistent drug availability.
Key Takeaways
- Leading Suppliers: Pfizer and Teva are the predominant global suppliers for both Cytarabine and Daunorubicin, with regional companies expanding their presence.
- Market Drivers: Patent expirations and increased generic manufacturing have enhanced supply and reduced costs.
- Regulatory Challenges: Compliance with GMP and other regulatory standards remains vital for market access and supply stability.
- Emerging Trends: Biosimilars, manufacturing innovation, and supply chain diversification will influence future availability.
- Procurement Strategy: Stakeholders should prioritize suppliers with robust regulatory compliance, manufacturing capacity, and regional presence to mitigate supply risks.
FAQs
1. Which companies are the largest suppliers of Cytarabine globally?
Pfizer and Teva lead the global market for Cytarabine, providing both branded and generic formulations with extensive manufacturing and distribution networks.
2. Are there regional differences in Daunorubicin suppliers?
Yes. While Pfizer, Teva, and Sandoz dominate global markets, Indian manufacturers like Sun Pharma are significant suppliers in Asia and emerging markets.
3. How do regulatory standards impact the supply of these chemotherapeutic agents?
Regulatory compliance with GMP, FDA, EMA, and WHO standards ensures product quality and safety, directly influencing supply chain integrity and market access.
4. What future trends could affect the supply of Cytarabine and Daunorubicin?
The emergence of biosimilars, technological manufacturing advancements, and regional manufacturing hubs are expected to enhance supply stability and reduce costs.
5. How can healthcare providers ensure a reliable supply of these drugs?
By engaging with suppliers demonstrating strong regulatory compliance, diversified manufacturing, and global distribution capabilities, providers can mitigate shortages and ensure consistent treatment availability.
References
- GlobalData. (2022). Oncology Market Overview: Cytarabine.
- IQVIA. (2022). The Impact of Patent Expirations on Anthracycline Drugs.
- WHO. (2021). Supply Chain Resilience in Oncology Drugs.
More… ↓
