Bulk Pharmaceutical API Sources for tazemetostat hydrobromide

Bulk Pharmaceutical API Sources for tazemetostat hydrobromide

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-13803C
AbaChemScene		CS-0101826
MolPort		MolPort-046-836-698
BLD Pharm		BD01166401

Bulk Active Pharmaceutical Ingredient (API) Sources for: Tazemetostat Hydrobromide

Last updated: August 1, 2025

Introduction

Tazemetostat hydrobromide is an oral, selective inhibitor of the enhancer of zeste homolog 2 (EZH2), an enzyme instrumental in epigenetic regulation. Approved by the FDA in 2020 for the treatment of epithelioid sarcoma, its therapeutic profile underscores significant potential for oncology applications. As a high-value oncology API, sourcing tazemetostat hydrobromide at scale involves navigating a complex landscape of manufacturing capabilities, regulatory standards, and supply chain considerations. This article provides a comprehensive overview of the primary API suppliers, the strategic factors influencing sourcing decisions, and emerging trends relevant to pharmaceutical companies seeking reliable bulk providers.

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Manufacturing Landscape for Tazemetostat Hydrobromide API

As a specialized epigenetic agent, tazemetostat hydrobromide is produced through complex synthetic pathways requiring advanced chemical expertise, stringent quality controls, and compliance with Good Manufacturing Practices (GMP). Currently, the manufacturing of tazemetostat hydrobromide is centralized among select biopharmaceutical and chemical companies, primarily those involved in innovative oncology therapeutics.

Key API Suppliers for Tazemetostat Hydrobromide

1. Epizyme, Inc.

Overview:
Epizyme, Inc., the originator of tazemetostat, holds the pivotal patent rights and manufacturing process know-how for the active compound. The company has developed in-house manufacturing capabilities to supply the drug for clinical trials and commercial distribution.

Supply Capabilities:
Epizyme maintains controlled manufacturing facilities compliant with GMP standards, prioritizing supply chain reliability for their product. Their focus remains on ensuring consistent API quality, adhering to regulatory certifications, and expanding production capacity to meet global demand.

Implications for Sourcing:

• Direct procurement from Epizyme offers assurance of original quality and regulatory compliance.
• The company’s strategic focus on expanding production lines supports future supply stability.
• As a proprietary manufacturer, partnerships or licensing agreements may be necessary for large-scale procurement, often involving negotiated terms and intellectual property considerations.

2. Contract Manufacturing Organizations (CMOs)

Given the complexity and cost of API production, many pharmaceutical companies turn to specialized CMOs with expertise in high-potency APIs and complex chemical syntheses.

Notable CMOs involved in Tazemetostat API Production:

• Almac Group:
  An established CMO with extensive experience in oncology APIs, Almac offers custom synthesis, pilot-scale manufacturing, and scale-up capabilities under rigorous GMP standards.

• BASF:
  As one of the leading chemical producers globally, BASF provides custom synthesis services and has a proven track record in producing complex active ingredients, including those with challenging synthetic pathways.

• Lonza:
  Renowned for advanced biopharmaceutical manufacturing, Lonza has expanded their portfolio to include small-molecule APIs, with a focus on quality, scalability, and regulatory support.

Considerations for Engaging CMOs:

• Capability to produce high-potency APIs in compliance with strict safety protocols.
• Flexibility in supply volumes, accommodating both clinical and commercial scale.
• Experience in navigating regulatory approval processes for complex chemical entities.
• Intellectual property and confidentiality agreements.

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Emerging and Alternative API Sources

As demand for tazemetostat hydrobromide escalates, new suppliers, particularly from emerging markets, are entering the landscape. These providers often offer cost advantages but require rigorous verification of quality standards and regulatory compliance.

3. Chinese and Indian API Manufacturers

Overview:
In recent years, India and China have become major global hubs for API manufacturing due to lower production costs and expanding chemical capabilities. Several companies have invested in the synthesis and scale-up of complex oncology APIs, including tazemetostat hydrobromide.

Notable Players:

• Hetero Drugs:
  An Indian manufacturer with an expanding portfolio of advanced small-molecule APIs, including epigenetic agents. Hetero emphasizes quality control, GMP compliance, and regulatory clearance.

• Sun Pharmaceutical Industries:
  Offers a wide range of APIs and has the capacity to manufacture complex compounds at scale, adhering to international quality standards.

• Zhejiang Tinpo Pharmaceutical Co., Ltd.:
  A Chinese manufacturer with capabilities in chemically complex APIs, including epigenetic modulators.

Risks and Considerations:

• Verification of GMP certification and regulatory approvals (e.g., US FDA, EMA).
• Ensuring quality consistency and purity levels necessary for clinical and commercial use.
• Potential IP considerations when sourcing from emerging markets.

Regulatory and Quality Considerations

Reliable sourcing of tazemetostat hydrobromide API hinges on regulatory validation and quality assurance. The API must conform to specifications outlined in the Common Technical Document (CTD), including purity, residual solvents, heavy metals, and stability profiles.

Pharmaceutical companies should prioritize suppliers with:

• Valid GMP certifications (US FDA, EMA, TGA, etc.).
• Proven track record in complex API manufacturing.
• Robust quality control protocols and analytical testing procedures.
• Transparent supply chain documentation and traceability.

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Strategic Sourcing Trends

1. Vertical Integration and Strategic Partnerships:
Biopharmaceutical firms increasingly stipulate vertical integration or long-term supply agreements to mitigate risks. Exclusive partnerships with Epizyme or established CMOs ensure supply stability besides fostering collaborative development.

2. Geographic Diversification:
Diversifying sources across regions mitigates risks related to geopolitical disruptions, regulatory variances, and supply chain delays.

3. Focus on Quality and Compliance:
Regulatory authorities scrutinize high-potency APIs, emphasizing rigorous quality management. Suppliers with demonstrable compliance records are preferred to avoid delays in registration or commercialization.

4. Supply Chain Transparency:
Advance due diligence on supplier manufacturing processes and quality audits are critical, especially when engaging with emergent API producers.

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Conclusion

Sourcing bulk tazemetostat hydrobromide API involves navigating a niche but expanding landscape. The primary domestic supplier remains Epizyme, Inc., with numerous CMOs serving as strategic partners capable of scaling production. Emerging markets, predominantly India and China, offer cost-effective alternatives but necessitate comprehensive vetting to ensure compliance with international standards. The trend toward strategic partnerships, supply chain diversification, and rigorous quality control underpins effective API procurement strategies in this high-demand oncology segment.

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Key Takeaways

• Primary supplier: Epizyme, Inc., retains control over API manufacturing for Tazemetostat hydrobromide, emphasizing quality and regulatory adherence.
• CMO partnerships: Leading contract manufacturers like Almac, BASF, and Lonza facilitate scalable, compliant production.
• Emerging markets: India and China are emerging as alternative sources, but require thorough quality verification.
• Regulatory compliance: GMP certification and transparent quality processes are non-negotiable for sustained supply.
• Strategic sourcing: Diversifying suppliers and establishing long-term partnerships mitigate supply risks and ensure ongoing access to high-quality APIs.

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FAQs

1. Who is the primary manufacturer of tazemetostat hydrobromide API?
Epizyme, Inc., the original developer and patent holder, is the primary manufacturer, controlling the supply and distribution for clinical and commercial uses.

2. Are there reputable third-party APIs available from CMOs?
Yes, contract manufacturing organizations such as Almac, BASF, and Lonza provide scalable, GMP-compliant synthesis for tazemetostat hydrobromide.

3. Can APIs from emerging markets be considered reliable?
While cost-effective, sourcing from India or China requires due diligence to verify quality, GMP compliance, and regulatory approvals to ensure reliability.

4. What are the critical quality considerations for bulk API sourcing?
Ensuring GMP certification, analytical validation, residual solvent control, impurity profiles, and batch-to-batch consistency are vital.

5. How can companies mitigate supply chain risks for tazemetostat API?
By diversifying suppliers, establishing long-term supply agreements, and conducting rigorous vetting and audits, companies can secure reliable access to high-quality API.

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References

[1] U.S. Food & Drug Administration. Tazemetostat - Epizyme. 2020.
[2] Epizyme, Inc. Company Website. Product Portfolio.
[3] Chemical Business NewsBase. 2022 Reports on Oncology API Manufacturing.
[4] Contract Pharma. Trends in API Supply Chain Management. 2021.
[5] International Pharmaceutical Regulators Forum. Guide to API Quality Standards.