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Suppliers and packagers for BUSULFEX
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BUSULFEX
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Otsuka Pharm | BUSULFEX | busulfan | INJECTABLE;INJECTION | 020954 | NDA | Otsuka America Pharmaceutical, Inc. | 59148-070-91 | 8 CARTON in 1 CARTON (59148-070-91) / 1 VIAL in 1 CARTON (59148-070-90) / 10 mL in 1 VIAL | 1999-02-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: Busulfex
Introduction
Busulfex (busulfan) is a chemotherapeutic agent primarily used for conditioning before hematopoietic stem cell transplantation (HSCT) in patients with chronic myelogenous leukemia and other hematologic malignancies. As an essential drug in oncology and transplant medicine, it has a critical supply chain involving multiple suppliers globally. Understanding these suppliers, their manufacturing capabilities, regulatory statuses, and market distribution is vital for pharmaceutical companies, healthcare providers, and procurement entities aiming for reliable access to Busulfex.
Overview of Busulfex and its Market
Busulfex, developed by Pfizer, is marketed as a sterile, lyophilized formulation of busulfan, an alkylating agent. Its patent protection has expired in many regions, leading to increased manufacturing and generic competition. As of recent years, several suppliers have entered the market, influencing pricing, availability, and regulatory dynamics. The primary focus for stakeholders is ensuring an uninterrupted supply, particularly given its lifesaving role in stem cell transplantation.
Major Suppliers of Busulfex (Busulfan)
1. Pfizer Inc.
Pfizer originally commercialized Busulfex (busulfan) as a branded product. As the patent-holder, Pfizer remains a significant supplier through its manufacturing facilities. Their global distribution network ensures steady supply to several markets. Despite generic entries, Pfizer continues to manufacture and distribute branded formulations, often associated with higher regulatory standards and quality assurance protocols.
2. LGM Pharmaceuticals
LGM Pharmaceuticals is a reputable API (Active Pharmaceutical Ingredient) manufacturer supplying busulfan API to various generic manufacturers and formulators worldwide. They have obtained regulatory approvals, including FDA compliance, making them a reliable source for bulk API used in compounded and finished-dose products. Their strategic focus on high-quality APIs positions them as a key supplier for generic busulfan formulations.
3. Sun Pharmaceutical Industries Ltd.
Sun Pharma manufactures and markets generic busulfan formulations across multiple regions, particularly in India and emerging markets. Their API manufacturing plants are FDA- and MHRA-approved, and they supply finished-dose formulations through various distribution partners. Their aggressive market penetration makes them a noteworthy supplier in the segment.
4. Fresenius Kabi
Fresenius Kabi offers sterile, lyophilized busulfan formulations, often targeting hospitals and infusion centers. As a global player with extensive experience in sterile oncology drugs, Fresenius Kabi maintains high manufacturing standards and distributes busulfan through regional subsidiaries in Europe, Asia, and North America. Their focus on infusion therapies ensures reliable supply for transplant conditioning regimens.
5. Accord Healthcare (part of Intas Pharmaceuticals)
Accord Healthcare supplies generic busulfan formulations, primarily in European and Asian markets. Their facilities adhere to stringent regulatory standards, including EMA and FDA approvals. They have expanded their portfolio rapidly, aiming to provide cost-effective alternatives to branded drugs.
6. Other Regional and Emerging Suppliers
Additional regional manufacturers include suppliers in China, India, and Eastern Europe, often producing API or finished formulations for local markets. These suppliers may have varying regulatory compliance levels but are becoming increasingly significant due to regional demand growth and the push for local manufacturing.
Regulatory and Quality Considerations
When sourcing busulfan, especially from multiple suppliers, compliance with regulatory agencies such as the FDA, EMA, PMDA, and local agencies is essential. Suppliers typically need to provide Certificates of Analysis, stability data, and manufacturing process transparency. The quality and sterility of sterile formulations, along with consistent API quality, directly impact clinical outcomes and patient safety.
Regulatory Trends
Recent regulatory emphasis on biosimilarity, bioequivalence, and Good Manufacturing Practices (GMP) standards influence supplier qualification processes. Suppliers with established regulatory approvals are preferred, especially by hospital pharmacies and procurement agencies seeking risk minimization.
Market Challenges and Supply Risks
Supply chain disruptions, geopolitical issues, and raw material shortages can impact busulfan availability. For instance, recent global events like the COVID-19 pandemic have caused manufacturing delays and logistical challenges across global pharmaceutical supply chains. Recognizing suppliers with diversified manufacturing bases and emergency stockpiles mitigates such risks.
Market Dynamics and Future Outlook
Generic Competition and Price Trends
The expiration of patents and regulatory approvals for generic versions have increased competition, leading to price reductions and expanded supply. This scenario benefits healthcare providers through cost savings but necessitates diligent supplier qualification to ensure quality.
Emerging Market Opportunities
Growing demand for hematopoietic stem cell transplantation globally, especially in Asia and Latin America, creates significant opportunities for regional suppliers. Companies that invest in capacity expansion and regulatory approvals will likely be better positioned to capture market share.
Innovation and Manufacturing Advances
Biopharmaceutical advancements, such as continuous manufacturing and improved sterilization techniques, could enhance supply stability. Suppliers investing in modern manufacturing facilities will gain competitive advantages, ensuring compliant, scalable, and quality-assured products.
Conclusion
The supply landscape for Busulfex (busulfan) comprises key players including Pfizer, LGM Pharmaceuticals, Sun Pharma, Fresenius Kabi, and Accord Healthcare. The convergence of regulatory standards, manufacturing capacity, and geopolitical factors influences product availability and market stability. Stakeholders must prioritize supplier qualification, quality assurance, and contingency planning to mitigate supply disruptions and maintain consistent patient access. The expanding global demand further underscores the importance of strategic sourcing and supplier diversification.
Key Takeaways
- Primary Suppliers: Pfizer remains the principal supplier of branded Busulfex, complemented by a growing roster of generic manufacturers such as LGM Pharmaceuticals, Sun Pharma, Fresenius Kabi, and Accord Healthcare.
- Regulatory Compliance: Ensuring supplier adherence to GMP and regulatory approvals (FDA, EMA) is critical for safety and efficacy.
- Supply Chain Risks: Volatility due to geopolitical tensions, raw material shortages, and global crises necessitates robust sourcing strategies.
- Market Trends: Increased competition from generics and regional manufacturers drives down prices but underscores the need for vigilant quality oversight.
- Future Outlook: Capacity expansion, manufacturing innovations, and regional market growth anticipate a resilient supply landscape for busulfan.
Frequently Asked Questions
1. Who are the top global suppliers of busulfan?
The leading suppliers include Pfizer (branded product), LGM Pharmaceuticals, Sun Pharma, Fresenius Kabi, and Accord Healthcare, with regional manufacturers playing significant roles in local markets.
2. What factors should healthcare providers consider when sourcing busulfan?
Providers should evaluate regulatory approvals, manufacturing quality, supply reliability, and whether the supplier adheres to GMP standards. Diversifying suppliers reduces risk.
3. How has patent expiration affected the busulfan market?
Patent expiry has increased market competition, leading to a proliferation of generic formulations, lowered prices, but also heightened vigilance on quality and supply stability.
4. Are there specific regulatory challenges with sourcing busulfan in emerging markets?
Yes, variability in regulatory standards and enforcement can pose challenges; selecting suppliers with strong compliance histories mitigates risks.
5. What is the outlook for busulfan supply security?
With ongoing manufacturing investments, regulatory strengthening, and regional market growth, the busulfan supply is expected to remain stable, provided proactive management addresses potential logistical disruptions.
References
- Pfizer Inc. product information and regulatory filings.
- LGM Pharmaceuticals API profile and manufacturing certifications.
- Sun Pharmaceutical product portfolio documentation.
- Fresenius Kabi manufacturing standards.
- Industry analysis reports on generic oncology drugs.
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