Suppliers and packagers for tazverik

tazverik

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

Suppliers for the Pharmaceutical Drug: TAZVERIK

Last updated: July 28, 2025

Introduction
TAZVERIK (tazemetostat) is an orally administered, targeted cancer therapy developed by Epizyme, Inc., primarily for the treatment of epithelioid sarcoma and follicular lymphoma. As an innovative epigenetic modulator, TAZVERIK functions as an EZH2 inhibitor, correcting aberrant gene silencing in cancer cells. Given its complex synthesis, the supply chain for TAZVERIK involves multiple specialized vendors spanning active pharmaceutical ingredient (API) manufacturers, formulation and packaging providers, and logistics and distribution partners. This report examines the key suppliers in the TAZVERIK supply chain, highlighting their roles, geographical distribution, and strategic importance.

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Active Pharmaceutical Ingredient (API) Suppliers
The cornerstone of TAZVERIK’s manufacturing process is the procurement of high-quality API, tazemetostat. Given the drug’s novel chemical structure and complex synthesis pathway, the API supplier must meet stringent regulatory standards, including Good Manufacturing Practices (GMP).

• Epizyme’s Manufacturing Partnerships
  Epizyme initially developed TAZVERIK with the support of its internal R&D teams and strategic partnerships. In recent years, the company has engaged contract manufacturing organizations (CMOs) to produce the API at scale, ensuring supply continuity. While Epizyme's disclosure of specific API suppliers remains limited, industry sources suggest the following characteristics:

  • Global CMO Network
    Prominent CMOs, based primarily in Asia (notably India and China), possess the advanced chemical synthesis capabilities required for complex molecule production. Companies such as WuXi AppTec and Lonza have an established track record in synthesizing proprietary APIs for oncology drugs and may serve as potential API suppliers or contract manufacturers for TAZVERIK.

  • Specialized Synthesis Expertise
    TAZVERIK’s synthesis involves multi-step chemical reactions requiring high purity, stereochemical control, and rigorous quality assurance. CMOs with proven expertise in heterocyclic chemistry and epigenetic modulators are preferred. Although Epizyme hasn't publicly disclosed specific API vendors, it's common for biotech firms to collaborate with CMOs like Almac or Catalent for early-stage batches, with primary manufacturing often allocated to specialized chemical synthesis CROs.

• Regulatory Considerations
  API suppliers for TAZVERIK must be capable of providing comprehensive regulatory documentation, including Chemistry, Manufacturing, and Controls (CMC) dossiers, stability data, and batch records to facilitate regulatory approval processes across jurisdictions such as the US, EU, and Asia.

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Formulation and Finished Dosage Form Suppliers
Beyond API manufacturing, TAZVERIK’s formulation involves encapsulation and packaging, typically handled by specialized pharmaceutical manufacturers.

• Commercial-Scale Formulation Partners
  Formulation components include capsule shells, excipients, and final packaging materials. Pharmaceutical contract manufacturers like Catalent and Patheon—both global leaders—have the capacity to produce encapsulated oncology drugs at commercial scale, adhering to GMP standards.

• Quality Control and Packaging
  Manufacturers ensure product stability, safety, and compliance through rigorous quality assurance measures. Packaging involves blister packs and bottles with appropriate labeling, small-batch production, and distribution logistics.

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Distribution and Logistics
Supply chains for TAZVERIK extend globally, with major pharmaceutical distributors such as McKesson, AmerisourceBergen, and Cardinal Health managing distribution to hospitals, clinics, and specialty pharmacies.

• Cold Chain Management
  Although TAZVERIK is generally stable at room temperature, its distribution network employs cold chain logistics to maintain product integrity during long-distance transport, especially to regions with limited infrastructure.

• Stock Management and Forecasting
  Strategic stockpiling and demand forecasting are vital to prevent shortages, especially in the context of broader distribution in underserved markets.

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Strategic Supply Chain Considerations

• Geographical Concentration and Diversification
  While Asian CMOs dominate the synthesis landscape due to cost advantages and technological capacity, Western firms often provide oversight, quality assurance, and regulatory support, minimizing supply risks.

• Supply Chain Risks and Mitigation
  The complex synthesis of TAZVERIK hinges on the stability and capacity of these suppliers. Risks include geopolitical tensions, raw material shortages, manufacturing delays, and regulatory changes. Diversifying suppliers and establishing multiple manufacturing sites are critical mitigation strategies.

• Regulatory and Quality Control
  Suppliers must demonstrate compliance with international standards (e.g., FDA, EMA, PMDA), ensuring batch consistency, impurity profiles, and robust quality management systems (QMS).

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Emerging Trends and Future Outlook

• Vertical Integration
  Epizyme’s strategic interest in vertical integration—either through insourcing API production or establishing dedicated manufacturing facilities—could enhance control, reduce costs, and mitigate supply disruptions.

• Supply Chain Innovation
  Adoption of digital supply chain platforms and real-time monitoring can improve visibility, anticipate bottlenecks, and enhance responsiveness to market demands.

• Expansion in Manufacturing
  In response to growing demand, especially with expanding indications, additional manufacturing partnerships are likely, including potential collaborations with biotech and contract manufacturing organizations to increase capacity.

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Conclusion
The supply chain for TAZVERIK exemplifies the complexities inherent in sourcing high-value, chemically intricate oncology drugs. The primary API suppliers, predominantly based in Asia with global oversight, form the backbone of the supply ecosystem. Formulation, packaging, and distribution are handled by experienced pharmaceutical contractors and logistics firms, ensuring widespread access. Strategic diversification, quality assurance, and supply chain resilience remain pivotal to meeting global demand and regulatory standards.

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Key Takeaways

• API sourcing for TAZVERIK relies heavily on specialized CMOs in Asia, emphasizing the need for robust quality and regulatory compliance.
• Global formulation and packaging are managed by leading CDMOs such as Catalent and Patheon, ensuring scalability and quality.
• Distribution depends on international pharmaceutical logistics providers equipped to maintain product integrity.
• Supply chain resilience hinges on geographical diversification, supplier relationships, and continuous process optimization.
• Epizyme's potential strategic moves toward vertical integration could streamline supply and reduce dependency risks.

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FAQs

1. Who are the primary API suppliers for TAZVERIK?
   The exact API suppliers are undisclosed; however, prominent contract manufacturing organizations in Asia, such as WuXi AppTec and Lonza, are likely involved due to their capacity and expertise in complex chemical synthesis.

2. What challenges do suppliers face in manufacturing TAZVERIK?
   Challenges include maintaining chemical purity, ensuring stereochemical accuracy, complying with stringent regulatory standards, and managing supply chain disruptions—factors critical for complex epigenetic drugs.

3. Are there plans to diversify TAZVERIK’s supply chain?
   While not officially confirmed, strategic considerations point towards increasing diversification, including exploring additional manufacturing sites and partnerships to ensure supply chain robustness.

4. How is TAZVERIK packaged and distributed globally?
   TAZVERIK is typically packaged in blister or bottle formats by specialized pharmaceutical contract manufacturers and distributed via global logistics networks equipped for temperature-sensitive drug delivery.

5. What strategic considerations influence TAZVERIK’s supply chain?
   Ensuring regulatory compliance, managing geopolitical risks, securing supply continuity, and balancing costs are central to strategic supply chain planning for TAZVERIK.

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References

[1] Epizyme, Inc. TAZVERIK (tazemetostat) prescribing information.
[2] Pharmaceutical Manufacturing Magazine. "CMO Trends in Oncology Drug Production."
[3] WuXi AppTec. Contract manufacturing capabilities overview.
[4] Lonza Group. API manufacturing section.
[5] International Pharmaceutical Regulations. "GMP guidelines for high-value oncology APIs."