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

Tazverik (tazemetostat) Suppliers: Who Manufactures Drug Product, API, and Key Components for US and EU Supply Chains

Last updated: May 24, 2026

Tazverik (tazemetostat) is supplied through a defined ecosystem of contract manufacturers and API makers that support commercial drug product batches and clinical supply. The supplier footprint is anchored by Eisai’s commercialization of tazemetostat and upstream manufacturing by specialized CDMOs for API and finished dose manufacturing.

Who supplies tazverik drug product and who makes tazemetostat API?

Short answer: Tazverik’s commercial supply chain is built on upstream API manufacturing by large-scale API producers/CDMOs and finished dose manufacturing by qualified pharmaceutical manufacturers that produce the marketed tablet strength(s) under cGMP for Eisai.

Because “tazverik suppliers” is often used to mean either (1) API sources, (2) finished dose (tablet) makers, or (3) raw-material component suppliers, the clean way to map the supply chain is by tier.

What are the likely supplier tiers for tazverik?

1. API manufacturer (tazemetostat active pharmaceutical ingredient)
   Tiered suppliers include API manufacturing sites capable of controlled synthesis, purification, and batch release under cGMP.

2. Finished dose manufacturer (tablet production and packaging)
   Tablet compression, film coating (if applicable to the dosage form), blistering or bottle packaging, and batch release.

3. Excipients and packaging suppliers
   Common pharmaceutical raw materials (binders, disintegrants, coatings, colorants when present) and primary/secondary packaging components.

Where do you verify the actual named sites?

Authoritative verification requires the manufacturing site list shown on regulatory filings (FDA drug master file references, label sections that list manufacturing/packaging, and CMC sections submitted to regulators). Without the specific label/manufacturing insert text and the corresponding FDA/NDA or supplements, the only defensible statement is that supplier identification is regulated by cGMP site qualification and reflected in product labeling and submissions.

What does the FDA label say about tazverik manufacturing sites?

Short answer: The US commercial manufacturing and packaging sites for tazverik are listed in the prescribing information and associated FDA labeling.

How to use the label to map suppliers

Look for:

• “Manufactured for” / “Distributed by” lines (company responsibility)
• “Manufactured by” and site addresses (CDMO or manufacturing company)
• Packaging (“Packaged by” / “Repackaged by”) lines when present

If the label is not included in the source set, exact named supplier companies cannot be stated with the level of precision required for supplier due diligence.

Who are the CDMOs behind tazemetostat tablets?

Short answer: Finished dose tablet production is performed by qualified contract manufacturers for Eisai.

Which manufacturers typically show up for oncology tablet CDMO work?

Common patterns across oncology small molecules:

• A tablet manufacturing site with solid oral dosage expertise and scale-up capability.
• A packaging site that provides stability packaging and label/lot handling.

But named company identification still requires the specific manufacturing section text from the label or a CMC site listing from regulator-accessible documents.

Who supplies tazemetostat API?

Short answer: API is produced at cGMP-compliant API facilities that support Eisai’s commercial and ongoing supply needs.

What makes API supplier selection critical for tazemetostat?

• Consistent impurity profile and control strategy
• Scale-up robustness across batches
• Compatibility with formulation and tablet dissolution specifications
• Regulatory audit history and change control maturity

What documents normally list the API supplier?

• NDA CMC sections and manufacturing correspondence
• Drug Master File references (DMF)
• Labeling references where the API source is named (less common than finished dose sites)

Without the actual FDA label and/or CMC site listings, the API supplier list cannot be stated accurately.

How do tazverik supplier changes impact supply risk?

Short answer: Supply risk rises when:

• A manufacturing site change requires comparability work and regulatory notifications
• Late-stage transfer strains packaging supply or stability stock
• Starting-material availability (key intermediates) tightens

What supply continuity indicators matter

• Batch release timelines
• Lot-to-lot impurity trends
• Packaging lead times for blister and bottle components
• Reserve capacity at the selected CDMOs

What is the competitive supply landscape for tazemetostat?

Short answer: The supply landscape is shaped less by “generic supplier count” and more by specialized commercial manufacturing capacity for solid oral oncology products and the API chemistry for tazemetostat.

What happens when manufacturing is outsourced?

• Eisai’s commercialization structure typically uses established CDMOs with prior oncology small-molecule experience.
• Supplier consolidation can occur after scale-up once commercial volumes are stable.

What generic or biosimilar angle matters for suppliers of tazverik?

Tazverik is a small-molecule drug, so “biosimilar” does not apply in the same way it does for biologics. The supplier question shifts toward:

• Generic applicant manufacturing capability
• ANDA/CMC demonstration of API source and process control
• Drug product bioequivalence and dissolution alignment

Key Takeaways

• Tazverik supply is supported by upstream API manufacturing and downstream CDMO tablet production plus packaging, all under cGMP and reflected in regulatory and label documentation.
• Exact named supplier companies and sites must be taken from the prescribing information manufacturing/packaging sections and associated FDA labeling/CMC site listings; otherwise, supplier identification cannot be stated precisely enough for procurement, licensing, or diligence use.

FAQs

1. How can I identify the actual tazverik finished dose manufacturer from official documents?
   Use the manufacturing and packaging lines in the US prescribing information and cross-check site addresses.

2. Does tazverik list the tazemetostat API supplier on the US label?
   Often the label emphasizes finished dose manufacturing and distribution; API source disclosure may be limited and typically requires CMC/DMF-level review.

3. What procurement risk is most common when CDMOs change for oncology tablets like tazverik?
   Batch comparability work and packaging/stability lead times.

4. When generic tazemetostat enters, what supplier capabilities determine product launch reliability?
   API process control, impurity control, solid oral formulation reproducibility, and packaging supply chain readiness.

5. Where do you verify CDMO sites for cGMP compliance for tazverik?
   Regulatory label manufacturing/packaging sections and submissions that list manufacturing sites.

References (APA)

1. U.S. Food and Drug Administration. (n.d.). Tazverik (tazemetostat) prescribing information and labeling. FDA.
2. U.S. Food and Drug Administration. (n.d.). Drug approvals and labeling information for tazemetostat. FDA.