Suppliers and packagers for generic pharmaceutical drug: BUSULFAN

BUSULFAN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Accord Hlthcare Inc	BUSULFAN	busulfan	INJECTABLE;INJECTION	210148	ANDA	Accord Healthcare, Inc	16729-351-92	8 VIAL, SINGLE-DOSE in 1 CARTON (16729-351-92) / 10 mL in 1 VIAL, SINGLE-DOSE (16729-351-03)	2019-07-22
Amneal	BUSULFAN	busulfan	INJECTABLE;INJECTION	209580	ANDA	Amneal Pharmaceuticals LLC	70121-1244-7	8 VIAL, SINGLE-DOSE in 1 CARTON (70121-1244-7) / 10 mL in 1 VIAL, SINGLE-DOSE (70121-1244-1)	2017-12-18
Eugia Pharma	BUSULFAN	busulfan	INJECTABLE;INJECTION	215102	ANDA	Eugia US LLC	55150-395-08	8 VIAL, SINGLE-DOSE in 1 CARTON (55150-395-08) / 10 mL in 1 VIAL, SINGLE-DOSE (55150-395-01)	2024-06-25

Suppliers for the Pharmaceutical Drug: Busulfan

Last updated: July 28, 2025

Introduction

Busulfan is an alkylating agent primarily utilized in the treatment of chronic myelogenous leukemia (CML) and as a conditioning agent before hematopoietic stem cell transplantation. Its unique efficacy and toxicity profile demand stringent manufacturing and sourcing standards. As a critical component in oncology and transplantation protocols, the procurement of high-quality busulfan hinges on reliable suppliers adhering to regulatory standards.

Market Overview

The global market for busulfan is characterized by a mixture of major pharmaceutical companies and generic producers. While originally developed and marketed by large pharmaceutical firms, the landscape has shifted toward extensive generic production to meet increasing demand, especially in emerging markets. Key suppliers span from pharmaceutical giants with proprietary formulations to reputable generic manufacturers providing cost-effective options.

Major Suppliers of Busulfan

1. Pfizer Inc.

• Overview: Pfizer is a pioneer in the development and commercialization of busulfan. Its product, Myleran, historically established as a standard in chemotherapy.
• Supply Role: Pfizer's manufacturing facilities produce branded busulfan formulations adhering to rigorous Good Manufacturing Practice (GMP) standards. The company's global distribution network ensures supply continuity across developed markets.
• Regulatory Compliance: Pfizer maintains strict compliance with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations, ensuring high purity and quality.

2. Cipla Limited

• Overview: An Indian multinational pharmaceutical company, Cipla has emerged as a significant generic producer of busulfan.
• Supply Role: Cipla offers generic versions of busulfan, compliant with international standards, often at lower costs, primarily serving markets in Asia, Africa, and Latin America.
• Regulatory Compliance: Cipla's manufacturing facilities meet WHO-GMP standards, with required approvals from health authorities such as the FDA, EMA, and national agencies.

3. Sun Pharmaceutical Industries Ltd.

• Overview: Sun Pharma is one of India's largest pharmaceutical firms offering bulk APIs and finished formulations.
• Supply Role: The company supplies busulfan API, catering to both generic formulations and contract manufacturing for global partners.
• Regulatory Compliance: Sun Pharma adheres to global GMP requirements with multiple regulatory approvals enhancing credibility.

4. Dr. Reddy's Laboratories

• Overview: A leading Indian pharmaceutical company known for producing high-quality active pharmaceutical ingredients.
• Supply Role: Reddy’s manufactures busulfan API for domestic and export markets.
• Regulatory Compliance: The company maintains multiple international certifications, including FDA and EMA approvals.

5. Fresenius Kabi

• Overview: A global healthcare company specializing in infusion therapies and pharmaceuticals.
• Supply Role: Fresenius Kabi produces ready-to-use formulations and APIs for busulfan, primarily serving hospital and IV formulation markets.
• Regulatory Compliance: Committed to high-quality standards aligning with WHO-GMP and US FDA regulations.

Factors Influencing Supplier Selection

• Regulatory Status: Manufacturers with proven regulatory compliance (FDA, EMA, TGA, etc.) are preferred for international procurement.
• Manufacturing Capacity: Reliable volume supply ensures minimal disruptions in clinical and treatment settings.
• Product Quality: Consistency, purity, and stability of busulfan batches are critical.
• Cost-effectiveness: Generic manufacturers often provide more affordable options, balancing quality.
• Market Presence: Well-established suppliers with geographic reach ensure supply security.

Supply Chain Challenges and Considerations

The procurement process must account for geopolitical risks, manufacturing disruptions, and regulatory variances. Additionally, due to busulfan's narrow therapeutic index and toxicity profile, suppliers must ensure raw material sourcing, quality assurance, and strict adherence to pharmacopoeial standards.

Emerging Suppliers and Patent Issues

Although original patents for busulfan have expired in many jurisdictions, some firms hold exclusive rights for specific formulations or delivery mechanisms. Emerging suppliers frequently push into markets via abrogated patents, emphasizing quality and compliance. It is essential to verify the legal status of patents and exclusivity rights before engaging with suppliers.

Regulatory Pathways and Approvals

Procurement of busulfan from international suppliers requires validation of regulatory approvals in the buyer’s jurisdiction. Import licenses, Good Supply Practice (GSP) compliance, and verification of batch records are mandatory steps to mitigate risk.

Conclusion

Selecting a reliable supplier for busulfan involves comprehensive evaluation of manufacturing quality, regulatory compliance, supply capacity, and cost. Leading global entities, such as Pfizer and Sun Pharma, provide assured quality, while key generic producers like Cipla and Dr. Reddy's support market accessibility through cost-effective options. The expanding landscape necessitates ongoing due diligence, particularly as biosimilar and generic markets evolve.

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Key Takeaways

• Major providers include Pfizer, Cipla, Sun Pharma, Dr. Reddy's, and Fresenius Kabi.
• Regulatory compliance (FDA, EMA, WHO-GMP) remains critical in supplier selection.
• Cost-effective generics expand market accessibility but must meet strict quality standards.
• Supply chain stability depends on manufacturing capacity, geopolitical factors, and regulatory approval.
• Due diligence in legal patent status and certification is essential to mitigate procurement risks.

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Frequently Asked Questions

1. Are there risks associated with sourcing busulfan from generic manufacturers?
Yes. While many generics meet international quality standards, variability in manufacturing quality, regulatory oversight, and raw material sourcing can pose risks. It's essential to verify certifications (e.g., WHO-GMP, FDA approval) and conduct audits or quality assessments before procurement.

2. How do regulatory differences impact busulfan supplier selection?
Suppliers compliant with the buyer’s regulatory environment provide assurance regarding safety, efficacy, and manufacturing standards. International approvals (FDA, EMA) facilitate cross-border procurement while maintaining adherence to quality legends.

3. What are the implications of patent expiration on busulfan supply?
Patent expiration generally opens markets for generics, increasing supply options and reducing costs. However, some formulations or delivery mechanisms may still be under patent protection, requiring due diligence on specific product rights.

4. How can healthcare providers ensure the quality of busulfan supplied from international vendors?
Providers should require batch certification, compliance documentation, and preferably audit manufacturing facilities. Utilizing reputable suppliers with established regulatory approvals mitigates risks.

5. What are the main logistical challenges in procuring busulfan globally?
Challenges include regulatory clearance, import restrictions, cold chain logistics (if applicable), language barriers, and geopolitical stability affecting supply routes. Planning and establishing strong supplier relationships help navigate these issues.

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References

[1] FDA Pharmaceutical Chemotherapy Guidelines.
[2] World Health Organization (WHO) Good Manufacturing Practices.
[3] Market analysis reports on generic pharmaceutical manufacturing, 2022.
[4] Company websites and official publications of Pfizer, Cipla, Sun Pharma, Dr. Reddy's, and Fresenius Kabi.