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Suppliers and packagers for generic pharmaceutical drug: tazemetostat hydrobromide
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tazemetostat hydrobromide
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Epizyme Inc | TAZVERIK | tazemetostat hydrobromide | TABLET;ORAL | 211723 | NDA | Epizyme, Inc. | 72607-100-00 | 240 TABLET, FILM COATED in 1 BOTTLE (72607-100-00) | 2020-01-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Tazemetostat Hydrobromide
Introduction
Tazemetostat hydrobromide is an orally administered selective inhibitor of EZH2 (Enhancer of Zeste Homolog 2), a key component in epigenetic regulation implicated in various cancers. Since its initial FDA approval in 2020 for metastatic or unresectable epithelioid sarcoma and follicular lymphoma, the demand for Tazemetostat has increased among pharmaceutical companies, healthcare providers, and research institutions. This article offers a comprehensive review of current and potential suppliers for Tazemetostat hydrobromide, analyzing manufacturing sources, supply chain dynamics, regulatory considerations, and market outlooks to assist stakeholders in making informed procurement and investment decisions.
Overview of Tazemetostat Hydrobromide
Tazemetostat hydrobromide is marketed under the brand name TAZVERIK® (Eisai and Epizyme), primarily for treating specific soft tissue and blood cancers. Its synthesis involves complex chemical processes, requiring specialized expertise, advanced manufacturing facilities, and strict regulatory compliance. The active pharmaceutical ingredient (API) is produced by several pharmaceutical manufacturers authorized by regulatory agencies, with differentiation in scale, quality standards, and regulatory approvals.
Primary Suppliers and Manufactures of Tazemetostat Hydrobromide
1. Epizyme Inc. (The Originator Company)
Epizyme, Inc. holds the original patent rights to Tazemetostat and associated formulations. As the pioneer in developing and commercializing Tazemetostat, Epizyme manages API procurement directly through in-house manufacturing facilities equipped with cGMP (current Good Manufacturing Practices) certifications. The company has invested heavily in establishing a robust supply chain to meet global demands.
Key points:
- Manufacturing facilities: Epizyme operates GMP-compliant manufacturing plants in the United States, specializing in monotherapy and combination therapy APIs.
- Supply commitments: Epizyme has entered licensing agreements with manufacturing partners to scale production.
- Regulatory approvals: As the originator, Epizyme ensures compliance with FDA, EMA, and other regulatory standards, which influences supplier quality.
2. Contract Manufacturing Organizations (CMOs)
Given the high complexity and cost of API synthesis, many pharmaceutical firms outsource manufacturing to specialized CMOs.
Major CMO Suppliers include:
- Dr. Reddy’s Laboratories: Reported to develop and produce certain oncology active ingredients, including those similar in synthesis complexity to Tazemetostat, under contract. However, specific details about Tazemetostat are proprietary or under NDA.
- Suzhou Amoy Pharmaceutical Co., Ltd. (China): Engages in synthesis and supply of various oncology APIs, possibly including Tazemetostat, subject to approval and certification.
- Cipla Limited: Known for manufacturing and supplying a broad range of APIs for cancer therapies; has capabilities to produce complex molecules.
- Amneal Pharmaceuticals: Expanding its portfolio to include specialty oncological APIs, potentially including Tazemetostat, under licensing or partnership agreements.
Note: The confidentiality surrounding proprietary API synthesis processes limits public verification of these manufacturers as suppliers for Tazemetostat hydrobromide specifically. However, the trend indicates reliance on regional CMOs for large-scale production.
3. Regional and Emerging Suppliers
In response to increasing global demand and patent exclusivity timelines, additional regional suppliers, especially in Asia, are entering the market.
- Hetero Labs (India): As a leading API manufacturer, Hetero specializes in innovative oncology compounds, with capacity to produce Tazemetostat under licensing.
- Mitsubishi Tanabe Pharma Corporation (Japan): Actively involved in the development of epigenetic therapies, with potential to manufacture Tazemetostat API under joint ventures or licensing agreements.
4. Authorized Distributors and API Brokers
Numerous regional distributors and API brokers facilitate procurement for smaller pharmaceutical firms and research institutions. Notable players include:
- Aptuit (Vista Oil & Gas): Provides contract API manufacturing and supply chain services.
- ChemCon GmbH: Supplies sourcing services and direct purchasing options for complex APIs, potentially including Tazemetostat.
Supply Chain Dynamics and Challenges
Market Concentration and Patent Status
Initially, Tazemetostat production was concentrated within Epizyme’s facilities, with licensing agreements extending capacity via CMOs. The expiration or successful patent challenges could prompt the entry of generic manufacturers, diversifying supply sources.
Regulatory Barriers
The production of Tazemetostat hydrobromide demands stringent compliance with cGMP standards. Regulatory approvals influence manufacturing sites and their capacity to supply commercial quantities globally. Bottlenecks may occur in countries with less established pharmaceutical regulatory frameworks.
Manufacturing Complexity
The synthesis involves complex chemical processes, including stereoselective reactions and specific purification steps. Any disruptions—such as supply shortages of key raw materials or intermediates—can significantly impact production.
Supply Risks
Risks include geopolitical tensions, export restrictions, raw material shortages, and manufacturing delays. The COVID-19 pandemic underscored vulnerabilities within pharmaceutical supply chains, emphasizing the need for diversified sourcing.
Market Outlook and Future Supply Opportunities
With expanding indications beyond epithelioid sarcoma and follicular lymphoma, demand for Tazemetostat is anticipated to grow. Investment in biosynthetic pathways and emerging manufacturing facilities, particularly in Asia, suggests a future-enabled increase in supply sources.
Emerging trends include:
- Patent expirations and biosimilars: Potential for generics post-patent expiry, increasing supply chain options.
- Collaborations and licensing: Increased partnerships between Epizyme and global manufacturers will facilitate broader access.
- Technological advancements: Process innovations may reduce manufacturing costs and increase yields, easing supply constraints.
Conclusion
Suppliers for Tazemetostat hydrobromide are predominantly centered around Epizyme’s proprietary manufacturing and a growing network of CMOs specializing in complex oncology APIs. The current landscape is characterized by a mix of originator control, licensing arrangements, and regional manufacturing expansion. Stakeholders seeking procurement strategies should evaluate supplier compliance with regulatory standards, manufacturing capacity, and geopolitical stability. The increasing demand driven by expanding indications and pipeline developments signifies a need for diversified sourcing and supply chain resilience.
Key Takeaways
- Major supplier: Epizyme holds primary manufacturing rights, with a reliance on licensed CMOs globally.
- Regional expansion: Asian CMOs and contract manufacturers are entering the market, providing additional sourcing options.
- Supply chain risks: Manufacturing complexity, regulatory barriers, and geopolitical factors influence availability.
- Future trends: Patent expirations and technological advances will likely diversify the supplier base and enhance supply stability.
- Procurement strategy: Companies should prioritize supplier compliance, capacity, and risk mitigation to ensure steady supply.
FAQs
1. Who are the primary manufacturers of Tazemetostat hydrobromide?
The primary manufacturer is Epizyme Inc., which supplies the API through its controlled facilities and licensing agreements with CMOs. Additional regional suppliers and contract manufacturers—primarily in Asia—are emerging as alternative sources.
2. Can I source Tazemetostat hydrobromide from generic manufacturers?
Potentially, once patents expire or licensing agreements are in place, generic manufacturers may produce Tazemetostat, increasing supply options. Currently, most supply is controlled by Epizyme and licensed partners.
3. What regulations govern the manufacturing of Tazemetostat API?
Manufacturing must comply with stringent cGMP standards regulated by agencies such as the FDA, EMA, and equivalent authorities in India, China, and other regions. These standards ensure product quality, safety, and efficacy.
4. Are there risks associated with sourcing Tazemetostat from regional suppliers?
Yes. Risks include quality variability, regulatory non-compliance, supply disruptions, and geopolitical factors. Due diligence and supplier qualification are essential for secure procurement.
5. How might future patent expiries affect the supplier landscape?
Patent expiries could enable generic manufacturers to enter the market, significantly increasing supply options and reducing costs. This will also encourage existing manufacturers to expand capacity or improve manufacturing efficiencies.
References
[1] FDA. TAZVERIK (Tazemetostat) Prescribing Information. 2020.
[2] Epizyme Inc. Corporate Website. Available at: https://www.epizyme.com.
[3] European Medicines Agency. Tazemetostat Summary of Product Characteristics.
[4] Market reports on oncology API manufacturing and supply chain trends, 2022.
[5] Recent patent filings and licensing agreements related to Tazemetostat.
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