Suppliers and packagers for BENDAMUSTINE HYDROCHLORIDE

BENDAMUSTINE HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Accord Hlthcare	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	POWDER;INTRAVENOUS	205574	ANDA	Accord Healthcare, Inc.	16729-250-03	1 VIAL, SINGLE-DOSE in 1 CARTON (16729-250-03) / 5 mL in 1 VIAL, SINGLE-DOSE	2022-12-07
Accord Hlthcare	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	POWDER;INTRAVENOUS	205574	ANDA	Accord Healthcare, Inc.	16729-251-05	1 VIAL, SINGLE-DOSE in 1 CARTON (16729-251-05) / 20 mL in 1 VIAL, SINGLE-DOSE	2022-12-07
Accord Hlthcare	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	POWDER;INTRAVENOUS	205574	ANDA	BluePoint Laboratories	68001-572-41	1 VIAL, SINGLE-DOSE in 1 CARTON (68001-572-41) / 20 mL in 1 VIAL, SINGLE-DOSE	2023-09-15

Suppliers for the Pharmaceutical Drug: Bendamustine Hydrochloride

Last updated: July 28, 2025

Introduction

Bendamustine Hydrochloride is a chemotherapeutic agent primarily used in the treatment of chronic lymphocytic leukemia (CLL), indolent non-Hodgkin's lymphoma (NHL), and other hematological malignancies. As an alkylating agent with a unique mechanism of action, its supply chain is vital for healthcare providers globally. This article provides a comprehensive overview of key suppliers, manufacturing sources, and market dynamics surrounding Bendamustine Hydrochloride, enabling stakeholders to understand procurement landscapes and strategic sourcing considerations.

Overview of Bendamustine Hydrochloride

Developed in the late 20th century, Bendamustine has gained approval from multiple regulatory agencies, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regional authorities. The drug is available both as a branded product and generic formulations. Its complex synthesis, involving multiple steps and specialized manufacturing processes, limits the number of high-quality suppliers capable of producing pharmaceutical-grade Bendamustine Hydrochloride under Good Manufacturing Practices (GMP).

Major Suppliers and Manufacturers

1. Cephalon / Teva Pharmaceuticals

Historical Context and Market Presence
Initially developed by Cephalon, Inc., Bendamustine was later acquired by Teva Pharmaceuticals after Cephalon's acquisition by Teva in 2011. Teva is a prominent global generic drug manufacturer with significant experience in cytotoxic agents, including Bendamustine Hydrochloride. Teva's formulation of Bendamustine is marketed under the brand names Treanda and Bendamustine Teva, with availability in major markets such as North America, Europe, and Asia.

Manufacturing Capabilities
Teva operates multiple GMP-certified facilities capable of producing pharmaceutical-grade Bendamustine Hydrochloride at scale, ensuring supply stability. Their extensive distribution network supports global access, although capacity constraints can occasionally influence availability.

2. Mundipharma

Emerging Market Presence
Mundipharma, a global network of independent associated companies, offers generic formulations of Bendamustine. Their focus primarily lies in markets such as India, Southeast Asia, and Eastern Europe. Mundipharma sources Bendamustine from various contract manufacturers meeting strict quality standards.

Manufacturing and Supply
Mundipharma's supply chain involves partnerships with Indian and Chinese pharmaceutical manufacturers, leveraging local expertise and cost advantages. These partnerships enable affordable access to Bendamustine Hydrochloride in emerging markets.

3. Pharmacyclics (A division of AbbVie)

Branded Formulation and Proprietary Production
Pharmacyclics developed a proprietary formulation of Bendamustine marketed as Treanda in the United States. As a licensed manufacturer, Pharmacyclics and later AbbVie maintain production capabilities for commercial supply. While primarily focusing on branded products, they play a crucial role in maintaining high-quality manufacturing standards for approved formulations.

4. Contract Manufacturing Organizations (CMOs)

Given the complexity of synthesis, several CMOs serve as key suppliers for both branded and generic Bendamustine Hydrochloride. Notable CMOs include:

• Generics manufacturers in India (e.g., Dr. Reddy's Laboratories, Natco Pharma)
• Chinese pharmaceutical manufacturers with GMP certifications
• European Contract Manufacturers specializing in cytotoxic drugs

Implication
The reliance on CMOs underscores the importance of quality assurance and regulatory compliance in sourcing Bendamustine Hydrochloride.

Supply Chain Dynamics and Market Players

Global Demand and Production Capacity

The demand for Bendamustine has risen with increased approval for indications like CLL and NHL. Supply constraints can arise from manufacturing complexities, regulatory delays, or raw material shortages. The concentrated manufacturing landscape, dominated by a few major producers, heightens the importance of diversified sourcing strategies.

Regulatory and Quality Standards

Suppliers must adhere to GMP standards to ensure drug purity, potency, and safety. Regulatory audits by agencies such as the FDA and EMA significantly influence supply chain robustness. Manufacturers in India and China have expanded GMP certifications to meet international standards, although disparities in regulatory enforcement can impact reliability.

Market Risks

Risks include batch failures, regulatory non-compliance, geopolitical factors affecting manufacturing and export, and patent expirations influencing generic competition.

Emerging Trends and Opportunities

• Patent Expirations: With the patent for Treanda expired in markets like Europe, generic manufacturers are increasing production, diversifying the supplier base.
• Contract Manufacturing Expansion: The growth of CMOs in Asia and Eastern Europe offers supply flexibility.
• Quality Assurance Advances: Enhanced regulatory oversight reduces counterfeit and substandard product risks.

Key Considerations for Procurement

• Supplier Reliability: Prioritize suppliers with GMP-certified facilities, proven track records, and transparent supply chains.
• Regulatory Compliance: Verify adherence to regional and international standards.
• Capacity and Lead Times: Assess manufacturing capacity and production lead times to mitigate shortages.
• Cost Dynamics: Balance quality with cost, especially when sourcing from emerging markets.
• Contingency Planning: Develop dual sourcing strategies to mitigate geopolitical or supply disruptions.

Conclusion

The supply of Bendamustine Hydrochloride hinges on a limited number of reputable manufacturers capable of meeting stringent quality standards and global demand. Leading suppliers like Teva Pharmaceuticals and Pharmacyclics represent the primary sources in developed markets, while emerging manufacturers in India and China expand availability through contracted manufacturing. For healthcare stakeholders, understanding these dynamics facilitates strategic procurement, ensuring uninterrupted access to this vital chemotherapeutic agent.

Key Takeaways

• Major suppliers include Teva Pharmaceuticals, Pharmacyclics (AbbVie), and Mundipharma, supplemented by multiple CMOs.
• The manufacturing landscape is concentrated, emphasizing the importance of supplier diversity.
• Strict regulatory standards are crucial; GMP compliance remains a non-negotiable criterion.
• Emerging markets are increasing their role, offering cost advantages but necessitating thorough quality vetting.
• Proactive supply chain management and contingency planning are vital to mitigate shortages and ensure patient access.

FAQs

1. Who are the leading global suppliers of Bendamustine Hydrochloride?
Teva Pharmaceuticals and Pharmacyclics (AbbVie) dominate the market in developed countries, with Indian and Chinese companies supplying generics through contract manufacturing and local partnerships.

2. What factors influence the reliability of Bendamustine Hydrochloride supply?
Manufacturing capacity, GMP compliance, regulatory approvals, raw material availability, and geopolitical stability significantly impact supply reliability.

3. Are there patent restrictions on Bendamustine Hydrochloride?
The original patents have expired in certain regions, enabling generic production, which broadens the supplier base and impacts pricing.

4. How do regulatory standards affect supplier selection?
Suppliers with GMP-certified facilities and proven compliance histories provide assurance of drug safety and efficacy, reducing risk of supply disruptions.

5. What are future trends impacting Bendamustine Hydrochloride supply?
Increased generic competition, expansion of contract manufacturing in emerging markets, and evolving regulatory requirements are shaping the supply landscape.

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Sources:

1. [1] FDA Drug Approvals Database.
2. [2] European Medicines Agency (EMA) Product Information.
3. [3] Teva Pharmaceuticals Annual Reports.
4. [4] Mundipharma Official Website.
5. [5] Industry analyses on cytotoxic drug manufacturing and supply chains.