Suppliers and packagers for generic pharmaceutical drug: TREOSULFAN

TREOSULFAN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Medexus	GRAFAPEX	treosulfan	POWDER;INTRAVENOUS	214759	NDA	Medexus Pharma, Inc.	59137-335-01	1 VIAL in 1 CARTON (59137-335-01) / 1 g in 1 VIAL	2025-01-28
Medexus	GRAFAPEX	treosulfan	POWDER;INTRAVENOUS	214759	NDA	Medexus Pharma, Inc.	59137-365-01	1 VIAL in 1 CARTON (59137-365-01) / 5 g in 1 VIAL	2025-01-28

Suppliers for the Pharmaceutical Drug: TREOSULFAN

Last updated: July 27, 2025

Introduction

Treosulfan, a bifunctional alkylating agent, is used primarily in chemotherapy for ovarian and peritoneal cancers. Its unique mechanism involves inducing DNA cross-linking, leading to cell apoptosis. As an essential chemotherapeutic agent, the supply chain landscape for treosulfan involves a combination of specialized manufacturers, compounding pharmacists, and regional suppliers. This analysis provides an in-depth overview of key suppliers, manufacturing sources, regulatory considerations, and strategic factors shaping the availability of treosulfan in the global pharmaceutical market.

Market Overview and Significance

Treosulfan holds significant importance in oncology treatment regimes, particularly in Europe and parts of Asia, due to its favorable toxicity profile and efficacy. Although not as globally widespread as other alkylating agents like cyclophosphamide or ifosfamide, treosulfan's niche status results in a limited yet specialized supplier base. Its production is primarily handled by biotech and pharmaceutical manufacturing firms with expertise in chemotherapy agent synthesis.

Major Suppliers and Manufacturers

1. Medac GmbH

Medac GmbH, based in Germany, is one of the leading producers of treosulfan, specifically marketed under the brand Treosulfan Medac. The company specializes in niche oncological and autoimmune medications, with a focus on high-quality chemotherapeutic agents. Medac’s dominance in the European market is reinforced by its comprehensive manufacturing capabilities and regulatory approvals within the European Medicines Agency (EMA).

2. GlaxoSmithKline (GSK)

While primarily known for its extensive portfolio of vaccines and pharmaceuticals, GSK historically engaged in the production of anticancer compounds, including treosulfan in some regions. However, the company's involvement appears limited to specific markets and distribution channels. GSK's production capacity for treosulfan is subject to regional licensing and manufacturing agreements.

3. Non-Commercial and Contract Manufacturers

Due to the specialized nature of treosulfan, several countries have contract manufacturing organizations (CMOs) capable of synthesizing and packaging treosulfan for regional markets, particularly in Asia and Eastern Europe. These include:

• Famar (Greece): Provides contract manufacturing for sterile chemotherapeutic agents.
• CordenPharma (France): Offers complex drug synthesis and sterile manufacturing, potentially including treosulfan on a custom basis.
• Suzhou Tianma Pharmaceutical (China): Known for producing generic chemotherapy agents, possibly including treosulfan under licensing agreements.

4. Emerging and Regional Suppliers

In recent years, some emerging pharmaceutical companies in India and Southeast Asia have expressed interest in producing generic versions of treosulfan. However, their market presence remains limited due to regulatory hurdles and intellectual property constraints.

Regulatory and Patent Landscape

Treosulfan’s patent status significantly influences its supply chain. In Europe, Medac holds exclusive rights for its formulation, supported by regulatory approvals. The patent landscape in other jurisdictions varies, with some countries allowing generic manufacturing post-expiry or license expiration. Manufacturers seeking entry into the treosulfan market must navigate complex regulatory frameworks, including European Registration (EMA), FDA approval processes, and regional drug listing requirements.

Supply Chain Challenges

• Manufacturing Complexity: Treosulfan's synthesis involves multi-step chemical processes requiring specialized equipment and containment protocols.
• Regulatory Barriers: Stringent quality assurance, stability testing, and licensing can delay or restrict market entry.
• Limited Manufacturing Base: Few companies possess the expertise and capacity to produce treosulfan at scale, constraining supply.
• Global Distribution: Ensuring consistent supply across regions depends heavily on regional regulatory approvals and logistical capabilities.

Regional Availability and Market Dynamics

Europe

Medac GmbH dominates treosulfan supply, with widespread use in Germany, Austria, and other European nations. The regulatory approval status simplifies importation and distribution within the EU. Hospitals and oncology centers rely heavily on Medac’s supply, making regional partnerships crucial.

Asia-Pacific

Emerging markets such as India, China, and Japan show increasing demand for chemotherapeutic agents, including treosulfan. Some regional manufacturers have initiated production under licensing agreements. However, data on distribution and licensing remain limited.

United States

Treosulfan is not currently approved for general medical use by the FDA, limiting domestic production and procurement. Importation relies on special regulatory pathways or compassionate use programs, constraining supply.

Emerging Markets

A growing interest in generic chemotherapeutic agents has spurred efforts by regional manufacturers to produce treosulfan. However, quality assurance and regulatory approval remain bottlenecks to wider availability.

Strategies for Stakeholders

• Vertical Integration: Companies looking to expand supply should consider collaborations with specialized synthesis firms or invest in in-house manufacturing.
• Regulatory Navigation: Early engagement with regional drug authorities facilitates approvals and market access.
• Patent Analysis: Continuous monitoring of patent expiry timelines can unlock opportunities for generic manufacturing.
• Supply Diversification: Diversifying suppliers reduces risk of shortages, especially given the complex manufacturing process and limited number of producers.

Future Outlook

Anticipated growth in the oncology market, coupled with advancements in manufacturing technology and harmonization of regulatory standards, could enhance treosulfan’s global supply chain robustness. Additionally, patent expirations and the emergence of generics may foster increased competition, potentially reducing costs and expanding regional availability.

Key Takeaways

• Medac GmbH remains the primary supplier in Europe, controlling most of the global supply of treosulfan.
• The manufacturing complexity and regulatory hurdles limit the number of active producers, constraining global supply.
• Emerging markets are exploring local licensing or generic production, but regulatory barriers remain.
• The regional regulatory environment heavily influences supplier viability and market access.
• Strategic partnerships, patent monitoring, and technological innovations are crucial for expanding treosulfan’s global availability.

FAQs

Q1: Who are the main manufacturers of treosulfan globally?
A1: Medac GmbH is the primary manufacturer and supplier of treosulfan in Europe. Other manufacturers operate under licensing agreements or provide contract manufacturing services in various regions, including Asia and Eastern Europe.

Q2: Is treosulfan available as a generic medication?
A2: Currently, treosulfan's primary marketed formulation is under patent protection by Medac in Europe. Generic versions could emerge following patent expiries or licensing agreements, but such availability is limited at present.

Q3: What regulatory bodies oversee treosulfan production and approval?
A3: The European Medicines Agency (EMA) oversees approvals in Europe. Regional agencies, such as the FDA in the United States, have not yet approved treosulfan for general use, limiting its market access there.

Q4: Are there regional suppliers outside Europe?
A4: Yes. Several regional manufacturers in Asia, particularly in China and India, are known to produce chemotherapy agents, including potential generic versions of treosulfan, under licensing agreements or for export.

Q5: What are the primary challenges in sourcing treosulfan?
A5: Challenges include limited manufacturing capacity due to complex synthesis, regulatory barriers impacting market access, patent protections, and regional distribution logistics.

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Sources
[1] European Medicines Agency. "Treosulfan." EMA Official Records.
[2] Medac GmbH. "Product information and technical data."
[3] CordenPharma. "Contract manufacturing of chemotherapeutic agents."
[4] GlobalData. "Pharmaceuticals Market Analysis."
[5] Regulatory Affairs Professionals Society. "Drug approval processes and patent landscapes."