Suppliers and packagers for GLEOSTINE

GLEOSTINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	GLEOSTINE	lomustine	CAPSULE;ORAL	017588	NDA	Azurity Pharmaceuticals, Inc.	24338-340-05	1 BOTTLE in 1 CARTON (24338-340-05) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE	2025-10-24
Azurity	GLEOSTINE	lomustine	CAPSULE;ORAL	017588	NDA	Azurity Pharmaceuticals, Inc.	24338-341-05	1 BOTTLE in 1 CARTON (24338-341-05) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE	2025-10-24
Azurity	GLEOSTINE	lomustine	CAPSULE;ORAL	017588	NDA	Azurity Pharmaceuticals, Inc.	24338-342-05	1 BOTTLE in 1 CARTON (24338-342-05) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE	2025-10-24

Suppliers for the Pharmaceutical Drug: GLEOSTINE

Last updated: August 5, 2025

Introduction

Gleostine, generically known as both mustard or chlorambucil, is a chemotherapeutic agent primarily used in the treatment of chronic lymphocytic leukemia (CLL), Hodgkin’s lymphoma, and certain other lymphoid malignancies. As an alkylating agent, gleostine functions by disrupting DNA replication in rapidly dividing cells, thus inhibiting cancer progression. Given its critical role in oncology, a robust and reliable supply chain for gleostine is paramount for healthcare providers and pharmaceutical companies. This article examines key suppliers, manufacturing landscapes, and the factors influencing the availability of gleostine globally.

Manufacturers of Gleostine (Chlorambucil)

Established Pharmaceutical Companies

Several multinational pharmaceutical corporations have historically manufactured gleostine, either as a proprietary product or under generic licensing agreements. Key industry players include:

• Teva Pharmaceutical Industries Ltd.
  A dominant generic drug producer, Teva supplies chlorambucil in various formulations globally. Their extensive manufacturing infrastructure and presence in emerging markets position them as a primary supplier.

• Sandoz (a Novartis division)
  Sandoz manufactures chlorambucil as part of its wide array of generic oncology medicines, adhering to high manufacturing standards aligned with regulatory requirements such as FDA and EMA.

• MediGene AG
  Although primarily focused on biotechnology, MediGene has engaged in developing formulations of alkylating agents, including chlorambucil, often supplying through licensing arrangements.

• Accord Healthcare
  A notable supplier of generic oncology products, including chlorambucil, particularly for markets in Europe and Asia.

Major Contract Manufacturing Organizations (CMOs)

• Hospira (a Pfizer subsidiary)
  Known for contract manufacturing of injectable and oral chemotherapeutics, Hospira has capabilities to produce chlorambucil for third-party clients and private label formulations.

• Rottapharm/Madaus Group
  Historically involved in the synthesis and supply of alkylating agents, Rottapharm supplies APIs (Active Pharmaceutical Ingredients) for oncological drugs, including chlorambucil.

Generic Production and Licensing

The generic industry accelerates supply availability. Several regional manufacturers produce chlorambucil under licensed agreements or through their own R&D efforts, often adapting the form for local markets.

Supply Chain Dynamics and Regulatory Considerations

Regulatory Approvals

Manufacturers must comply with rigorous standards from agencies such as the FDA, EMA, and Japanese PMDA. These regulatory frameworks influence manufacturing capacity, quality control, and market access.

Geographical Distribution

Supply chains for gleostine are most robust in regions with mature pharmaceutical markets, including North America, Europe, and Japan. Emerging markets, notably India and China, also host numerous generic manufacturers that produce chlorambucil.

Market Challenges

• API Production Constraints
  The synthesis of chlorambucil hinges on complex chemical processes, which can be affected by raw material availability and manufacturing variables, leading to potential supply disruptions.

• Regulatory Hurdles
  Stringent approval processes may delay entry or renewal of manufacturing licenses, impacting supply stability.

• Cost and Patent Status
  As a long-established generic, gleostine is often subject to price competition; patent barriers are less relevant, allowing multiple sources.

Impact of Market Dynamics

Global demand fluctuations, patent expirations, and geopolitical issues influence the proliferation of suppliers. For example, the expiry of patents in the early 2000s spurred broad licensing and manufacturing by various generics companies, increasing supply robustness.

Emerging Alternatives and Supply Considerations

Advances in targeted therapies and monoclonal antibodies have slightly altered oncology treatment landscapes, but chlorambucil remains relevant, especially in resource-constrained settings. The continual presence of multiple suppliers ensures that shortages of gleostine are rare but can occasionally occur due to production issues or regulatory delays.

Quality Assurance and Supply Reliability

Maintaining high-quality standards is critical given the therapeutic importance and toxicity profile of gleostine. Suppliers typically adhere to cGMP (current Good Manufacturing Practices), with batch testing, stability studies, and lot traceability. Inspection and accreditation by authorities such as the FDA or EMA further underpin supply reliability.

Conclusion

The supply of gleostine hinges on a diversified network of world-class manufacturers, primarily including established pharmaceutical giants and specialized CMOs. The long-standing patent expiration and generic manufacturing landscape foster competitive production, promoting stable availability. However, factors such as API synthesis complexity, regulatory compliance, and geopolitical influences require ongoing vigilance to sustain consistent supply chains for this critical chemotherapeutic agent.

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Key Takeaways

• Multiple suppliers, notably Teva, Sandoz, and Accord Healthcare, ensure broad availability of gleostine globally.
• Contract manufacturing organizations play an essential role in supplementing capacity and facilitating regional supply.
• Stringent regulatory standards sustain product quality but may occasionally impact manufacturing continuity.
• Ongoing market dynamics, including generic proliferation and geopolitical factors, influence supply stability.
• For healthcare providers, maintaining relationships with multiple suppliers and monitoring regulatory updates are vital for uninterrupted access to gleostine.

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FAQs

1. Who are the primary global suppliers of gleostine?
Teva, Sandoz, and Accord Healthcare are among the leading manufacturers distributing chlorambucil worldwide, supported by dedicated contract manufacturers.

2. How does regulation affect the supply of gleostine?
Regulatory compliance ensures quality but can delay manufacturing licensing or renewal, impacting availability if approvals are not maintained or if inspections reveal deficiencies.

3. Are there regional differences in gleostine sourcing?
Yes. Developed markets tend to have a wide array of approved generic manufacturers, whereas some regions rely heavily on imported supplies due to local manufacturing limitations.

4. What challenges threaten the stability of gleostine supply?
API synthesis complexities, raw material shortages, production disruptions, regulatory delays, and geopolitical issues can all threaten supply continuity.

5. Are there alternatives to gleostine in chemotherapy protocols?
Yes. Alternatives include other alkylating agents, targeted therapies, or monoclonal antibodies, but gleostine remains a preferred option in certain treatment protocols, especially where cost and resource constraints are considerations.

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Sources

[1] U.S. Food and Drug Administration (FDA). Approved Drug Products with Therapeutic Equivalence Evaluations.
[2] European Medicines Agency (EMA). Marketing Authorisations.
[3] Teva Pharmaceutical Industries. Product Portfolio.
[4] Sandoz. Generic Oncology Drugs.
[5] Market Research Reports on Oncology Drug Manufacturing.