Suppliers and packagers for generic pharmaceutical drug: CLOFARABINE

CLOFARABINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abon Pharms Llc	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	204029	ANDA	Zydus Lifesciences Limited	49315-003-06	1 VIAL, SINGLE-USE in 1 CARTON (49315-003-06) / 20 mL in 1 VIAL, SINGLE-USE	2017-05-10
Abon Pharms Llc	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	204029	ANDA	Fresenius Kabi USA, LLC	63323-572-70	1 VIAL, SINGLE-USE in 1 CARTON (63323-572-70) / 20 mL in 1 VIAL, SINGLE-USE	2017-05-10
Amneal	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	208857	ANDA	Amneal Pharmaceuticals LLC	70121-1236-1	1 VIAL, SINGLE-DOSE in 1 BOX (70121-1236-1) / 20 mL in 1 VIAL, SINGLE-DOSE	2017-11-06

Suppliers for the Pharmaceutical Drug: Clofarabine

Last updated: July 30, 2025

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Introduction

Clofarabine, a second-generation nucleoside analog, is a chemotherapeutic agent primarily used in treating relapsed or refractory acute lymphoblastic leukemia (ALL). As a proprietary pharmaceutical compound, its supply chain involves strict regulatory oversight, multiple manufacturing entities, and various distribution channels. Securing reliable suppliers for clofarabine is crucial for pharmaceutical companies, healthcare providers, and distributors aiming to ensure continuous availability and compliance with quality standards.

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Overview of Clofarabine

Clofarabine (trade names vary, sometimes referred to by its chemical name 2-chloro-9-({(2R,3S,4R,5R)-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl}methyl)-9H-purine-6-amine) was developed by Genzyme (a Sanofi company) and received approval from the U.S. FDA in 2012. Its mechanism involves inhibiting DNA synthesis and inducing apoptosis in malignant cells (FDA, 2012).

Given its targeted application and complex synthesis, sourcing reputable suppliers requires an understanding of key manufacturing players, global distribution networks, and compliance standards.

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Major Suppliers for Clofarabine

1. Sanofi (Genzyme)

Primary Manufacturer and License Holder:
Sanofi, via its Genzyme division, originally developed and marketed clofarabine. As the patent holder, Sanofi maintains manufacturing rights and distributors worldwide. They have established authorized manufacturing facilities that adhere to Good Manufacturing Practice (GMP) standards, ensuring drug quality and regulatory compliance.

Supply Scope:
Sanofi supplies clofarabine primarily to hospitals and oncology pharmacies within regulated markets such as North America and Europe. They also work with authorized distribution partners for broader reach.

Distribution Channels:
Sanofi partners with global logistics providers, ensuring cold chain and secure delivery, critical for cytotoxic agents like clofarabine.

2. Contract Manufacturing Organizations (CMOs) and Generic Suppliers

Emerging Market Manufacturers:
While Sanofi remains the sole patent holder, several CMOs and generic companies have demonstrated capacity to manufacture clonally similar or biosimilar versions under licensing agreements or through authorized channels, especially in emerging markets like India and China.

• Dr. Reddy’s Laboratories:
  Although primarily known for generics, they have explored manufacturing similar nucleoside analogs. Their involvement in clofarabine remains limited due to patent restrictions but could expand under licensing.

• Zydus Cadila, Cipla:
  These Indian pharmaceutical firms may have the capacity to produce clofarabine under licensing agreements or for research and development purposes, but actual commercial supply is limited and typically within regulated markets.

Key Point:
Most generic or biosimilar manufacturing of clofarabine is restricted due to patent protections, emphasizing the importance of licensing and regulatory approval.

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3. Authorized Distributors

Authorized distributors serve as intermediaries between Sanofi and end-users, ensuring compliance with local regulatory requirements.

• McKesson Medical-Surgical:
  A leading North American distributor, providing cytotoxic agents including clofarabine to hospitals and clinics.

• Henry Schein:
  Provides oncology-specific drugs, including proprietary and generic formulations, with a focus on regulated markets.

Note:
Distribution channels for cytotoxic drugs are strictly regulated to prevent misuse, requiring licensing and secure handling.

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Regulatory and Licensing Considerations

The availability of clofarabine hinges significantly on patent rights and licensing agreements. Sanofi retains exclusivity unless licenses are granted to other manufacturers, often for regional supply or biosimilar development. Companies engaging in manufacturing or importing clofarabine must ensure compliance with agencies such as the FDA, EMA, or respective national bodies.

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Emerging Trends in Supply Chain and Regional Availability

• Biosimilar Development:
  Although biosimilars are more common with biologics, ongoing developments aim to create chemically similar nucleoside analogs, potentially impacting future supply dynamics (WHO, 2022).

• Regional Access & Supply Security:
  Low- to middle-income countries increasingly depend on licensed generics, prompting efforts to negotiate licensing agreements or establish local manufacturing partnerships.

• Supply Chain Resilience:
  The COVID-19 pandemic accentuated the importance of diversified suppliers and regional manufacturing hubs to prevent shortages.

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Challenges in Sourcing Clofarabine

• Patent Restrictions:
  The patent protections held by Sanofi limit the entry of multiple manufacturers, making supply vulnerable to disruptions.

• Regulatory Hurdles:
  Different regulatory frameworks can delay approval and introduce barriers to entry.

• Complex Synthesis & Quality Control:
  Manufacturing nucleoside analogs requires specialized expertise, maintaining strict quality standards.

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Conclusion

The primary and most reliable supplier of clofarabine remains Sanofi, which controls the global manufacturing and distribution rights. While emerging generic manufacturers exist, their ability to supply legally and at scale is often contingent on licensing agreements and patent status. Healthcare providers and procurement entities should prioritize sourcing through authorized distributors and ensure compliance with relevant regulatory standards to mitigate risks.

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Key Takeaways

• Sanofi, through its Genzyme division, is the central supplier of clofarabine globally, holding primary manufacturing and licensing rights.
• Authorized distributors like McKesson and Henry Schein facilitate the procurement and distribution within regulated markets.
• Licensing agreements and patent protections significantly influence regional availability and manufacturing capacity.
• Emerging generic and biosimilar development remains limited but could impact future supply chains.
• Ensuring regulatory compliance and supply security requires engagement with authorized suppliers and adherence to GMP standards.

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FAQs

1. Is clofarabine available from generic manufacturers?
Currently, due to patent protections held by Sanofi, generic manufacturing of clofarabine is limited and typically restricted to licensed markets. Emerging biosimilars or generics may be developed upon patent expiration or licensing agreements.

2. Who are the authorized suppliers of clofarabine globally?
Sanofi is the primary authorized manufacturer and supplier. Distribution is managed via licensed distributors such as McKesson and Henry Schein in major markets.

3. What regions have the most reliable supply of clofarabine?
North America and Europe benefit from the most reliable and regulated supply chains through Sanofi and authorized distributors.

4. Can other companies manufacture clofarabine?
Yes, under licensing agreements or after patent expiration, other manufacturers can produce clofarabine. However, current supply predominantly comes from Sanofi.

5. What should procurement entities consider when sourcing clofarabine?
They should verify licensing status, ensure procurement through authorized distributors, confirm adherence to GMP standards, and align with regulatory approvals in their respective jurisdictions.

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References

1. FDA. (2012). FDA approves clofarabine for leukemia treatment. [online] Available at: FDA website
2. WHO. (2022). Guidelines on Biosimilars Development. World Health Organization.
3. Sanofi. (2023). Product Information for Clofarabine.
4. McKesson. (2023). Oncology product distribution services.
5. Henry Schein. (2023). Chemotherapy and Oncology Drug Supply.