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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 and packagers for generic pharmaceutical drug: tazemetostat hydrobromide
Who Supplies Tazemetostat Hydro bromide (TAZEMETOSTAT HBr) Materials?
Tazemetostat hydrobromide is supplied through a limited set of global generic and specialty APIs and through packager-led supply chains. Commercial procurement typically breaks down into: (1) API manufacturers for tazemetostat (often supplied as the free base or as a specific salt form) and (2) salt-form conversion and formulation supply where the contracted deliverable is specifically “tazemetostat hydrobromide.”
Which suppliers provide tazemetostat hydrobromide?
The supplier set depends on whether the buyer requires the exact salt form (hydrobromide) versus accepting the free base with internal salt conversion. Under typical industry procurement practice for salt-validated APIs, suppliers quote the requested salt form or provide a salt-conversion option through the same qualified supply chain.
Common procurement categories for tazemetostat HBr
| Procurement need | Typical supplier capability | What the contract usually specifies |
|---|---|---|
| API as tazemetostat hydrobromide | API manufacturer with salt-form capability and QC release testing | Identity (salt form), assay, residual solvents, polymorph/solid form controls |
| API as tazemetostat (base) + buyer-led salt conversion | API manufacturer for tazemetostat base only | Base API CoA specs and customer conversion acceptance criteria |
| API formed into a specific intermediate salt grade | Specialty chemical supplier or in-house conversion | Salt verification method and stability/impurity limits |
Actionable supplier landscape for tazemetostat (salt-validated supply)
- API and specialty chemical supply: Look for vendors that explicitly list “tazemetostat” and the hydrobromide salt in their catalog, or that can provide a salt-form certificate (identity + impurity package).
- Qualified supply chain: If the buyer’s quality agreement requires the exact salt form, prioritize suppliers with published deliverables that name tazemetostat hydrobromide in CoA and/or SDS.
How do you screen suppliers for true “tazemetostat hydrobromide” delivery?
You need salt-form certainty. Use a screening checklist aligned to how APIs are released and how salts are verified in pharma supply.
Supplier screening points (must be contractually defined)
- Identity method that distinguishes the salt
- Salt form confirmation via XRPD, DSC, Raman, or equivalent.
- CoA must state the delivered form as hydrobromide (not inferred from “tazemetostat” alone).
- Impurity and degradation controls specific to salt form
- Limit framework for related substances and known degradants.
- Statement on water content or hydrate status if relevant to the supplier’s material.
- Specifications and analytical package
- Release: assay, related substances, residual solvents, water (or KF), heavy metals.
- Stability: short-term and long-term data for the salt form in the stated storage container.
Where do most commercial supplies come from?
Tazemetostat is a small-molecule oncology drug with a supply chain dominated by:
- API manufacturers with scalable synthetic routes for the tazemetostat core,
- salt-form manufacturing capability to control solid-state properties,
- distributor networks that repackage and broker documented API lots into customer-specific logistics.
In practice, many buyers do not source directly from every API producer. They use distributors that carry inventory and can provide lot-level documentation quickly, while still tying the lot back to the API manufacturer via traceability.
What does “supplier” mean in your procurement workflow?
For high-stakes R&D and investment diligence, “supplier” should be interpreted as:
- The entity that issues the CoA/SDS for the lot you receive, and
- The entity that is traceable as the API manufacturer in the documentation pack.
Many firms can sell the material; far fewer can provide salt-form validation and a complete release package for tazemetostat hydrobromide.
Key Takeaways
- “Tazemetostat hydrobromide” supply depends on whether the deliverable is the exact salt form with salt-form identity controls, not just “tazemetostat” as a base chemical.
- Use salt-specific screening: the CoA/SDS and analytical package must explicitly confirm the hydrobromide form using an identity method that distinguishes salt form.
- Supplier diligence should focus on traceability to the API manufacturing source and on solid-state quality controls (XRPD/DSC/Raman), not only on listing claims.
FAQs
1) Can suppliers deliver tazemetostat hydrobromide from tazemetostat free base?
Yes, some suppliers offer a conversion or salt-prep pathway, but the receiving party must require salt-form identity confirmation and a salt-specific impurity and stability package.
2) Why do salt form requirements matter for procurement?
Salt form impacts identity, impurity profile, solid-state behavior, and downstream formulation compatibility. Contracts should reflect the exact salt form and required analytical methods.
3) What documents prove the material is the hydrobromide salt?
A lot’s CoA and SDS that explicitly name tazemetostat hydrobromide, paired with an identity method that distinguishes the salt form (e.g., XRPD/DSC/Raman) and related substances specifications.
4) Do distributors qualify as suppliers for regulatory-grade material?
Distributors are often the seller of record for logistics and inventory, but quality responsibility should be anchored to traceability back to the API manufacturing source and the qualified documentation pack.
5) What is the fastest path to reliable lot-level sourcing?
Select suppliers that can deliver lot traceability plus salt-form analytical release data on demand for the exact material name “tazemetostat hydrobromide.”
References
[1] FDA. Labeling for tazemetostat-containing products (Zelboraf is for vemurafenib; for tazemetostat: Tazverik, prescribing information and related regulatory documents). U.S. Food and Drug Administration. https://www.fda.gov/ (accessed 2026-04-23).
[2] EMA. EPAR and related documents for tazemetostat (Tazverik). European Medicines Agency. https://www.ema.europa.eu/ (accessed 2026-04-23).
[3] ICH. Guidelines for specifications, stability, and analytical methods (Q-series). International Council for Harmonisation. https://www.ich.org/ (accessed 2026-04-23).
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