Suppliers and packagers for nipent

nipent

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: NIPENT

Last updated: July 29, 2025

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Introduction

NIPENT (pentostatin) is a chemotherapeutic agent primarily used in the treatment of hairy cell leukemia and certain other hematological malignancies. Developed and marketed by pharmaceutical companies, NIPENT remains an essential drug in oncology, particularly owing to its efficacy in very specific lymphoid malignancies. Its market dynamics, supply chain, manufacturing, and key suppliers are relevant for healthcare providers, investors, and pharmaceutical procurement entities aiming to understand the drug’s availability and market landscape.

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Overview of NIPENT (Pentostatin)

Pentostatin, with the chemical name 2'-deoxycoformycin, functions as an adenosine deaminase (ADA) inhibitor, leading to accumulation of toxic metabolites in malignant lymphocytes, thereby inducing cell death. Approved by the U.S. Food and Drug Administration (FDA) in 1991, NIPENT remains a niche but critical component of hematological oncology.

The drug’s manufacturing process employs complex biological synthesis, necessitating a robust supply chain for active pharmaceutical ingredients (APIs), excipients, and finished formulations. Numerous pharmaceutical suppliers, often operating under strict regulatory standards, play roles in maintaining its supply consistency.

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Major Suppliers and Manufacturers of NIPENT

1. Prolonged Market Presence of Teva Pharmaceuticals

Teva Pharmaceuticals is historically recognized as the primary supplier and marketer of NIPENT. Its global manufacturing and distribution network ensure widespread availability, particularly in North America and Europe.

• Manufacturing Capabilities: Teva has extensive facilities specializing in sterile injectables and cytotoxic agents, including pentostatin.
• Supply Chain Strengths: Their established logistics ensure timely distribution, critical given the drug’s specialized use.

2. Mylan (Now part of Viatris)

Viatris, formed from Mylan and Pfizer’s Upjohn division, has inherited Mylan's portfolio of oncology and niche injectable drugs, including pentostatin.

• Manufacturing Footprint: Multiple facilities worldwide manufacture sterile cytotoxic drugs, with quality assured per international standards.
• Market Role: Mylan/Viatris supplies healthcare providers principally across North America and Europe, with some presence in emerging markets.

3. Hospira (A Pfizer Business)

Though Hospira was acquired by Pfizer in 2015, its legacy in sterile manufacturing remains integral.

• Specialization: Focused on sterile injectable oncology drugs, Hospira’s production lines support pentostatin’s formulation.
• Sourcing: Pfizer, through Hospira, continues to supply NIPENT, especially in North America.

4. Local and Regional Manufacturers

In recent years, some emerging markets have seen local pharmaceutical companies producing generic or biosimilar versions of pentostatin under licensing agreements or global sourcing deals.

• India: Companies such as Sun Pharmaceutical Industries and Cipla have expressed interest in cytotoxic generics, with some manufacturing capacity aligned with international standards.
• Eastern Europe: Several regional generic firms produce pentostatin derivatives for their respective markets.

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Supply Chain and Distribution Factors

The supply of NIPENT hinges on several critical factors:

• Regulatory Compliance: Manufacturers must adhere to stringent Good Manufacturing Practices (GMP) regulated by agencies like the FDA, EMA, and other national authorities.
• Raw Material Sourcing: The production of pentostatin involves complex fermentation processes, requiring high-purity substrates and enzymes.
• Shelf Life & Stability: Due to its cytotoxic properties, proper storage and handling are essential, affecting distribution logistics.
• Global Demand: While its use remains niche, the demand in specialized oncology centers influences inventory levels across suppliers.

Market Dynamics and Competition

Despite the limited pool of suppliers, competition primarily revolves around quality, reliability, and price. Patent expirations have not been significant for pentostatin, as it was approved years before the current patent frameworks tightened, but market entry barriers remain high due to manufacturing complexities.

Additionally, the shift toward biosimilars and other targeted therapies in hematology could impact future demand and supply chain adjustments for NIPENT.

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Regulatory and Procurement Challenges

• Supply Disruptions: Any issues such as manufacturing outages, regulatory delays, or raw material shortages can severely impact availability.
• Pricing Pressures: The niche nature supports relatively stable pricing, but procurement agencies face ongoing negotiations.
• Global Events: Pandemic-related disruptions demonstrated the importance of diversified manufacturing sources.

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Conclusion

The supply of NIPENT is predominantly maintained by established pharmaceutical giants like Teva Pharmaceuticals, Viatris, and Pfizer/Hospira, owing to their extensive manufacturing infrastructure and regulatory compliance. While regional production exists, global procurement relies heavily on these major suppliers due to the drug’s specialized nature. Stakeholders must monitor regulatory landscapes, manufacturing capacity, and geopolitical stability to ensure uninterrupted availability.

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Key Takeaways

• Market Dominance: Teva Pharmaceuticals is the principal supplier of NIPENT, supported by Viatris and Pfizer/Hospira.
• Supply Security: The manufacturing complexity and regulatory compliance standards act as high barriers to entry, limiting supplier diversity.
• Regional Variations: Emerging markets may see local manufacturers producing generics, though these are less prevalent.
• Supply Risks: Disruptions in raw material supply, manufacturing, or regulatory approval can impact availability.
• Strategic Considerations: Procurement entities should diversify sources where possible and establish long-term supply agreements to mitigate risks.

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FAQs

1. Who are the primary global suppliers of NIPENT?
The main suppliers include Teva Pharmaceuticals, Viatris (formerly Mylan), and Pfizer/Hospira, each with extensive manufacturing capabilities for sterile cytotoxic drugs.

2. Are biosimilars or generics available for NIPENT?
Currently, no widely approved biosimilars or generics have entered the market; manufacturing complexities and regulatory hurdles limit new entrants, although regional manufacturing exists.

3. How are supply chain disruptions minimized for NIPENT?
Established manufacturers maintain multiple sterile manufacturing facilities, adhere to GMP standards, and create supply agreements to ensure consistent availability.

4. Can regional manufacturers replace global suppliers?
While regional companies may produce pentostatin locally, their capacity and regulatory approval status are often less established, making them supplementary rather than replacement options.

5. What impact could future market trends have on NIPENT supply?
Emerging targeted therapies and biosimilars may reduce demand, potentially leading to supply adjustments or decreased manufacturing focus. Conversely, supply chain innovation can enhance resilience.

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References

[1] U.S. Food and Drug Administration. NIPENT (Pentostatin) Drug Approval.
[2] European Medicines Agency. Summary of Product Characteristics for Pentostatin.
[3] Teva Pharmaceuticals Product Portfolio. Company Website.
[4] Viatris Product List. Company Website.
[5] Pfizer Global Manufacturing Network. Company Report.