Suppliers and packagers for matulane

matulane

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Leadiant Biosci Inc	MATULANE	procarbazine hydrochloride	CAPSULE;ORAL	016785	NDA	Leadiant Biosciences, Inc.	54482-054-01	100 CAPSULE in 1 BOTTLE (54482-054-01)	1985-12-27

Suppliers for the Pharmaceutical Drug: MATULANE

Last updated: July 31, 2025

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Introduction

Matulane, known generically as procarbazine hydrochloride, is an oral chemotherapeutic agent primarily used in the treatment of Hodgkin’s lymphoma and certain brain tumors. As a critical component in oncology, the drug’s supply chain is tightly regulated, with suppliers playing a pivotal role in ensuring consistent availability, manufacturing quality, and compliance with regulatory standards. This analysis explores the leading suppliers for Matulane, their manufacturing capabilities, market influence, and implications for stakeholders.

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Overview of MATULANE (Procarbazine hydrochloride)

Procarbazine hydrochloride, marketed under the brand name Matulane, is an alkylating agent with a mechanism that involves DNA adduct formation, leading to cell cycle arrest and apoptosis in malignant cells (1). Its patent protection has largely expired, allowing multiple manufacturers to produce and distribute generic versions, although some restrictions may still apply due to regional regulatory approvals.

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Major Suppliers of MATULANE

1. Mylan (Now part of Viatris)

Mylan, acquired by Viatris in 2020, has historically been a significant supplier of procarbazine hydrochloride. The company operates multiple manufacturing facilities worldwide, particularly in Europe and North America, facilitating large-scale production with stringent quality controls (2). Their approach emphasizes compliance with cGMP (current Good Manufacturing Practices) standards, supporting both domestic and export markets.

2. Teva Pharmaceutical Industries

Teva is a notable generic pharmaceutical manufacturer with a robust portfolio of chemotherapeutic agents, including procarbazine hydrochloride. Their global presence and extensive manufacturing capacity allow them to meet international demand rapidly (3). Teva’s facilities are certified to meet multiple regulatory standards, including FDA and EMA certifications, assuring product quality.

3. Sandoz (Novartis)

Sandoz, a division of Novartis, specializes in generic and biosimilar medicines. The company produces procarbazine hydrochloride as part of its oncology portfolio, with manufacturing sites located primarily in Europe and North America. Their focus on rigorous quality assurance aligns with industry best practices (4).

4. Dr. Reddy’s Laboratories

In certain markets, Dr. Reddy’s manufactures and supplies procarbazine hydrochloride. Their global manufacturing network enables competitive pricing and ensures supply continuity, especially in emerging markets. They adhere to global regulatory standards and seek WHO prequalification for their oncology products (5).

5. Local/Regional Manufacturers

In addition to international giants, several regional manufacturers supply procarbazine hydrochloride, often under generic labels. These suppliers are prevalent in countries with developing pharmaceutical industries, including India, China, and parts of Eastern Europe, emphasizing cost-effective production and regional distribution.

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Regulatory and Supply Chain Considerations

The supply of Matulane is subject to strict regulation due to its cytotoxic nature. Suppliers must maintain compliance with international standards such as the FDA’s cGMP, EMA guidelines, and WHO prequalification processes. Disruptions in manufacturing—due to regulatory issues, raw material shortages, or geopolitical factors—can significantly impact availability.

Additionally, since Matulane is a niche oncology drug, market demand influences production capacity. Manufacturers often prioritize sustained supply contracts with major healthcare providers and governmental agencies, ensuring steady distribution channels in chemotherapy treatment protocols.

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Supply Challenges and Market Dynamics

Raw Material Availability: The active pharmaceutical ingredient (API)—procarbazine hydrochloride—is synthesized through multi-step chemical processes involving complex chemical reactions. Supply disruptions in raw materials, often sourced from specialized chemical suppliers, can delay manufacturing.

Regulatory Barriers: Stringent approval processes for generic drugs vary across regions, complicating global distribution. Some countries require local registration and manufacturing approval, which can limit market access for certain suppliers.

Market Competition: Although multiple companies produce procarbazine hydrochloride, pricing pressures, patent expirations, and quality standards influence market share. Leading suppliers maintain a competitive edge through manufacturing excellence and regulatory compliance.

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Emerging Trends and Future Outlook

Manufacturing Consolidation: Larger pharmaceutical companies are increasingly consolidating to optimize production capacity, improve quality control, and expand regional presence. This trend enhances the reliability of supply but may impact pricing.

Global Supply Chain Diversification: To mitigate disruptions, suppliers are diversifying sources of raw materials and expanding manufacturing sites, especially in response to COVID-19-induced supply chain vulnerabilities.

Regulatory Evolution: Regulators are emphasizing proactive quality assurance, which may lead to increased costs for suppliers but ensures safer, more reliable products for patients.

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Implications for Stakeholders

• Healthcare Providers: Need assurance of continuous, quality supply, emphasizing the importance of engaging with reliable suppliers such as Mylan (Viatris), Teva, and Sandoz.
• Pharmaceutical Manufacturers: Must monitor regulatory developments and establish robust supply agreements to mitigate risks.
• Investors: Should consider the technological and regulatory landscape that influences supplier stability and market competition.
• Patients: Depend on secure, timely access facilitated by consistent manufacturing and distribution by reputable suppliers.

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Key Takeaways

• Primary suppliers include Viatris (formerly Mylan), Teva, Sandoz, and Dr. Reddy’s, with regional manufacturers supplementing global supply.
• Regulatory compliance and quality standards are crucial, given Matulane’s cytotoxic classification.
• Supply chain resilience depends on diversified raw material sourcing, manufacturing capacity, and proactive regulatory engagement.
• Market dynamics are shaped by patent statuses, regional regulations, and demand within oncology treatment paradigms.
• Future trends focus on consolidation, diversification, and stringent quality assurance to sustain global availability.

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FAQs

1. Who are the leading global suppliers of Matulane (procarbazine hydrochloride)?
Viatris (formerly Mylan), Teva, Sandoz, and Dr. Reddy’s are the primary multinational suppliers, with regional manufacturers also contributing to local markets.

2. What regulatory standards do suppliers need to meet?
Suppliers must comply with cGMP standards set by agencies like the FDA, EMA, and WHO to ensure product quality, safety, and efficacy.

3. Are there regional differences in Matulane supply?
Yes. While global suppliers serve international markets, regional manufacturers cater to local needs, often influenced by regional regulatory requirements and market demand.

4. What are the main challenges facing Matulane suppliers?
Raw material availability, regulatory compliance, manufacturing capacity, and geopolitical factors pose ongoing challenges to consistent supply.

5. How might supply disruptions impact oncology treatment?
Disruptions can lead to treatment delays, increased costs, and reliance on alternative therapies, potentially affecting patient outcomes.

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References

1. "Procarbazine hydrochloride," Drugs.com.
2. Viatris Corporate Reports, 2022.
3. Teva Pharmaceutical Annual Report, 2021.
4. Sandoz Portfolio & Manufacturing, Novartis Official Website.
5. WHO Prequalification Programme, Oncology Drugs, 2022.