Last updated: April 23, 2026
What is OJEMDA and who supplies it?
OJEMDA is the brand name for tazemetostat (an EZH2 inhibitor) marketed in the U.S. by Eisai Inc.. The commercial supply chain is tied to the marketing authorization holder (Eisai) and the contract manufacturing footprint used for tazemetostat dosage forms.
Who is the marketing authorization holder and commercial supplier?
- Eisai Inc. is the U.S. marketing authorization holder for OJEMDA (tazemetostat).
- Source: U.S. FDA label for OJEMDA lists Eisai Inc. as the manufacturer/holder on the prescribing information. (See FDA label via DailyMed) [1].
Which contract manufacturers supply OJEMDA drug substance or drug product?
The supplier list for OJEMDA is determined by:
1) Label-referenced manufacturer information (drug product manufacturing and packaging), and
2) Regulatory registrations and inspections tied to tazemetostat supply (drug substance and/or finished dosage forms).
However, the complete, label-level named manufacturing facilities and packaging contractors for OJEMDA are not present in the content available in the provided material for this response. With no verifiable facility-level supplier names shown in the available text, a definitive “who supplies OJEMDA” list cannot be produced without risking inaccuracy.
What supplier roles matter for OJEMDA sourcing?
For commercial procurement and R&D vendor qualification, suppliers typically fall into these role categories:
- Finished-dose manufacturer (tablets/capsules production, coating, compression, packaging)
- Packaging house (bottling, label application, carton packing)
- Drug substance manufacturer (API production for tazemetostat)
- Sterile vs. non-sterile: OJEMDA is oral, non-sterile, so the supply chain is built around solid-dose and API capability, not sterile filling
OJEMDA sourcing snapshot (verifiable only)
| Item |
Supplier / Holder |
Evidence |
| OJEMDA U.S. commercial marketing |
Eisai Inc. |
FDA label prescribing information via DailyMed [1] |
OJEMDA supplier due-diligence checklist (procurement-ready)
Because OJEMDA supply sits on a solid-dose manufacturing model, diligence typically focuses on:
- GMP site eligibility for the finished dosage form
- Batch release testing coverage (identity, assay, impurity profile, dissolution)
- API traceability (tazemetostat source and impurity control)
- Change control history (site changes, scale-up, process changes)
Where to verify named facility suppliers (regulatory evidence path)
The only supplier statement that can be asserted from the currently provided, citable material is the marketing authorization holder. Named facility suppliers for drug product and packaging generally appear in:
- The U.S. FDA label (manufacturer/labeler or “Manufactured for” / “Distributed by” sections), and
- The full prescribing label document hosted on FDA label systems (DailyMed and FDA label PDFs)
The cited material for this response supports Eisai as the label/holder supplier, but it does not include the facility names needed to build a complete supplier roster [1].
Key Takeaways
- Eisai Inc. is the U.S. commercial marketing authorization holder for OJEMDA (tazemetostat). [1]
- A complete list of named contract manufacturers and packaging suppliers for OJEMDA cannot be stated from the available citable content in this response without introducing error.
- For supplier qualification, procurement should rely on label-identified manufacturers and confirm through GMP registration/inspection records tied to the specific OJEMDA dosage form.
FAQs
1) Who supplies OJEMDA in the U.S.?
Eisai Inc. supplies OJEMDA as the U.S. marketing authorization holder per the FDA label. [1]
2) What is the active ingredient in OJEMDA?
OJEMDA is tazemetostat (EZH2 inhibitor). [1]
3) Are OJEMDA manufacturing suppliers the same as the marketing holder?
Not necessarily; the marketing holder (Eisai) can use one or more contract manufacturers for drug product and packaging, which must be verified from the label manufacturing sections. [1]
4) What types of suppliers matter for OJEMDA sourcing?
Finished-dose manufacturers, packaging houses, and API (drug substance) producers, all under non-sterile solid-dose GMP controls.
5) How do investors or R&D teams validate OJEMDA supply risk?
By mapping label-identified manufacturers to registered GMP sites and tracking batch release history and manufacturing changes for the specific dosage strengths.
References
[1] U.S. Food and Drug Administration. OJEMDA (tazemetostat) prescribing information. DailyMed. https://dailymed.nlm.nih.gov/
