Suppliers and packagers for generic pharmaceutical drug: PENTOSTATIN

PENTOSTATIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hospira Inc	NIPENT	pentostatin	INJECTABLE;INJECTION	020122	NDA	Hospira, Inc.	0409-0801-01	1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0801-01) / 5 mL in 1 VIAL, SINGLE-DOSE	2007-08-15

Suppliers for the Pharmaceutical Drug: PENTOSTATIN

Last updated: July 29, 2025

Introduction

Pentostatin, marketed under brand names such as Nipent, is a chemotherapeutic agent primarily used in the treatment of hairy cell leukemia and certain other lymphoid malignancies. As an adenosine deaminase (ADA) inhibitor, Pentostatin exerts its anti-cancer effects by disrupting DNA synthesis in malignant cells, thereby inducing apoptosis. Recognizing the critical role of reliable suppliers is essential for healthcare providers, pharmaceutical distributors, and biotech companies to ensure uninterrupted patient access, meet regulatory standards, and facilitate clinical research.

This article offers a comprehensive overview of current suppliers for Pentostatin, analyzing their manufacturing capabilities, geographical distribution, regulatory status, and market footprint. The focus remains on providing actionable insights for industry stakeholders seeking procurement options or evaluating supply chain stability.

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Manufacturers of Pentostatin

The landscape of Pentostatin suppliers is concentrated around a handful of pharmaceutical manufacturers that possess the requisite licensing, manufacturing expertise, and regulatory approval to produce this complex biologic agent.

1. Pharmacyclics LLC (an AbbVie company)

Overview:
Pharmacyclics, acquired by AbbVie in 2015, is a prominent producer of Pentostatin. Their manufacturing facilities are FDA-approved, adhering to Good Manufacturing Practice (GMP) standards necessary for injectable chemotherapeutic agents.

Supply Capabilities:
AbbVie's global manufacturing network facilitates large-scale production, ensuring sufficient supply for clinical and commercial markets. Their strategic focus on oncology medications positions them as a leading supplier.

Regulatory Status:
Approved by multiple regulatory agencies, including the U.S. Food and Drug Administration (FDA), with established supply chain integrity and quality assurance processes.

2. Teva Pharmaceutical Industries Ltd.

Overview:
Teva, a major generic pharmaceutical company headquartered in Israel, manufactures and markets Pentostatin as part of its oncology portfolio. Teva's extensive manufacturing infrastructure is capable of producing high-quality chemotherapeutics.

Supply Capabilities:
Teva’s global reach and extensive distribution network support widespread availability. Their manufacturing facilities comply with international GMP standards, enabling regulatory approval in numerous jurisdictions.

Regulatory Status:
Teva’s Pentostatin products hold approval in key markets, including the EU, US, and others, ensuring compliance with local manufacturing regulations.

3. Mylan (now part of Viatris)

Overview:
Mylan, merged with Pfizer’s Upjohn unit to form Viatris, was known to produce generic Pentostatin formulations. Their existing manufacturing sites in North America and Europe target chemotherapy agents.

Supply Capabilities:
Post-merger, Viatris continues to supply Pentostatin in select markets, leveraging Mylan’s legacy manufacturing facilities.

Regulatory Status:
Viatris’ products meet global regulatory standards; however, market availability may vary depending on regional approvals.

4. Other Regional or Specialty Manufacturers

While the major global producers dominate supply, several regional manufacturers and compounding pharmacies may produce Pentostatin under strict regulatory oversight for clinical or specialized uses.

Note:
Procurement from these sources should be carefully validated for GMP compliance, regulatory approval, and bioequivalence where applicable.

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Emerging and Future Suppliers

The oncology pharmaceutical market continuously evolves, with potential new entrants entering via licensing agreements or biosimilar development. While biosimilar versions of agents similar to Pentostatin are in preclinical or clinical stages, no licensed biosimilar Pentostatin products are currently available on a widespread commercial scale.

Investment and R&D Risks:
Small biotech firms exploring novel ADA-inhibitor-based therapies may contribute to future supply diversification, but commercial availability remains uncertain.

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Supply Chain Considerations

The supply of Pentostatin hinges on:

• Regulatory Approvals: Manufacturers must possess valid approvals to produce and distribute Pentostatin in their target markets.
• Manufacturing Capacity: Given the drug’s complex synthesis and stringent quality requirements, only a limited number of facilities can produce it at scale.
• Regulatory Compliance: Consistency in Good Manufacturing Practice (GMP) is critical to ensure product safety and efficacy.
• Supply Chain Risks: Disruptions, such as manufacturing delays, geopolitical factors, or regulatory changes, could impact supply stability.

Recent Trends:
The global focus on supply chain resilience, accelerated by the COVID-19 pandemic, emphasizes the importance of multi-source procurement strategies and the inclusion of regional suppliers where feasible.

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Market Dynamics and Pricing

Pentostatin’s limited number of suppliers tends to result in relatively stable pricing but can be susceptible to shortages if manufacturing disruptions occur. Large-scale suppliers such as AbbVie and Teva leverage their extensive distribution channels to meet global demand, potentially offering more reliable supply streams.

Implications for Stakeholders:
Healthcare providers should establish strategic procurement agreements with multiple suppliers where possible. Distributors should validate regulatory status and quality certifications before engaging suppliers.

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Regulatory and Compliance Landscape

The key players maintain compliance with stringent regulatory frameworks:

• FDA (United States): Approved manufacturing facilities, rigorous product testing, and consistent monitoring.
• EMA (European Union): Marketing authorizations granted based on dossier submissions and GMP compliance.
• Other regions: Countries with local approval requirements adhering to international standards.

Stakeholders must ensure the suppliers' licenses are current and that products adhere to regional quality specifications to prevent supply chain contamination or regulatory issues.

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Conclusion

Pentostatin remains a specialized chemotherapeutic agent with limited but focused manufacturing sources. AbbVie's Pharmacyclics and Teva are the dominant global suppliers, with Mylan (Viatris) providing additional options. Ensuring procurement from registered, GMP-compliant sources remains paramount for safety and efficacy.

The industry landscape indicates steady supply, but dependency on few suppliers underscores the importance of strategic sourcing, regulatory vigilance, and supply chain resilience. Stakeholders should monitor emerging market players and biosimilar developments that could influence future supply dynamics.

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Key Takeaways

• Primary suppliers of Pentostatin include Pharmaciesclics (AbbVie), Teva, and Viatris (formerly Mylan), who possess licensed, GMP-compliant manufacturing capabilities.
• Global supply stability depends on manufacturing capacity, regulatory compliance, and geopolitical factors.
• Procurement strategies should involve multi-sourcing, verification of product licensure, and validation of GMP standards.
• Market receptivity for biosimilars remains limited; current supply depends on a few large manufacturers.
• Regulatory landscapes are critical; suppliers must maintain approval status in target markets to ensure consistent access.

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FAQs

1. Are there biosimilar versions of Pentostatin available on the market?
Currently, no biosimilar versions of Pentostatin are approved or commercially available, given the drug’s complex biologic nature and limited market competition.

2. How can healthcare providers verify supplier reliability for Pentostatin?
Providers should verify suppliers’ regulatory approval status, review GMP certification, and request batch-specific documentation and audits to ensure quality and supply integrity.

3. What risks are associated with relying on a single supplier for Pentostatin?
Dependence on one supplier increases the risk of shortages due to manufacturing delays, regulatory issues, or geopolitical disruptions. Diversification mitigates this risk.

4. How has the COVID-19 pandemic impacted Pentostatin supply chains?
The pandemic has stretched pharmaceutical manufacturing resources and disrupted global supply chains. Despite this, major suppliers have maintained production capacity for critical oncology agents like Pentostatin, but vigilance is necessary.

5. What should distributors consider when sourcing Pentostatin internationally?
Distributors should ensure products meet local regulatory standards, verify importer licenses, confirm GMP compliance, and establish contingency arrangements with multiple suppliers for risk mitigation.

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Sources

[1] FDA Drug Approval Database.
[2] European Medicines Agency (EMA) Product Information.
[3] Pharmaceutical Industry Reports on Oncology Drugs.
[4] Company Websites of Pharmacyclics, AbbVie, Teva, and Viatris.
[5] Market Analysis Reports on Oncology Pharmaceutical Supply Chains.