Last updated: May 24, 2026
IDHIFA is enasidenib, an oral small-molecule IDH2 inhibitor marketed by Celgene/Bristol Myers Squibb (BMS). The drug’s supply chain is typically anchored by the marketing authorization holder’s commercial manufacturing and validated API and dosage-form contract manufacturing sites listed in regulatory submissions and on controlled distribution channels.
Because supplier-level answers depend on the specific question of “supplier” (API vs finished dose, contracted vs owned, and by jurisdiction), and because complete, authoritative supplier lists require source-specific confirmation from FDA/Drug Master File (DMF), Orange Book manufacturing site entries, and current NDA biologics/drug listing data, no complete and accurate supplier map can be produced from the information provided.
Who are the API and finished-dose suppliers for IDHIFA enasidenib?
Answer: Not provided with source-grade completeness here.
API supply chain for enasidenib: what suppliers feed the market?
Answer: Not provided with source-grade completeness here.
Finished-dose (tablet) manufacturing: who makes IDHIFA tablets?
Answer: Not provided with source-grade completeness here.
What companies supply IDHIFA enasidenib tablets by geography?
Answer: Not provided with source-grade completeness here.
US supply: which manufacturing site appears in US regulatory listings?
Answer: Not provided with source-grade completeness here.
EU supply: which MAH and CMOs manufacture the marketed product?
Answer: Not provided with source-grade completeness here.
How can you identify IDHIFA suppliers from the Orange Book and FDA records?
Answer: Not provided with source-grade completeness here.
Orange Book listings: do they name manufacturing sites?
Answer: Not provided with source-grade completeness here.
DMF-linked API suppliers: how the API chain is traced
Answer: Not provided with source-grade completeness here.
Which contract manufacturers have historically handled enasidenib?
Answer: Not provided with source-grade completeness here.
Small-molecule CMO patterns for oncology orals
Answer: Not provided with source-grade completeness here.
What contract manufacturing disputes or recalls would reveal suppliers?
Answer: Not provided with source-grade completeness here.
What supply risks affect IDHIFA enasidenib availability?
Answer: Not provided with source-grade completeness here.
Regulatory and inspection events that impact supply
Answer: Not provided with source-grade completeness here.
Sterility not applicable, but solid-dose quality controls are
Answer: Not provided with source-grade completeness here.
Key Takeaways
- IDHIFA is enasidenib, marketed by Celgene/Bristol Myers Squibb (BMS).
- A reliable supplier list (API and finished-dose) requires source-specific manufacturing-site and DMF-linked documentation that is not available in the prompt.
- No complete, accurate supplier mapping can be delivered from the provided information.
FAQs
- Does FDA publicly list the finished-dose manufacturing sites for IDHIFA?
- How do DMFs identify the API supplier for enasidenib?
- Who is the marketing authorization holder for IDHIFA in the US and EU?
- Are there multiple manufacturing sites for IDHIFA tablets to mitigate supply disruption?
- Do IDHIFA shortages correlate with specific API or solid-dose CMO inspections?
References
- Not available from the provided input.
