Idhifa 100 mg tablet is a prescription medicine containing Enasidenib for oral use, marketed by Celgene, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C-25°C (68°F-77°F), excursions permitted between 15°C-30°C…
Key facts
- Active ingredient (INN)
- Enasidenib
- Brand
- Idhifa
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets
- Marketing authorisation holder
- Celgene
- Manufacturer
- Celgene
- Origin register
- US FDA, United States
- Storage
- Store at 20°C-25°C (68°F-77°F), excursions permitted between 15°C-30°C (59°F-86°F). Store and dispense in the original bottle (with a desiccant canister) to protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01XX59 Enasidenib
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 August 2017
- Identifiers
- RxCUI 1940370, 1940372, 1940374 +1DailyMed set ID a5b4cdf0-3fa8-4c6c-80f6-8d8a00e3a5b6NDC 59572-710Application NDA209606
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 30 tablet, film coated in 1 bottle | 59572-710-30 | Celgene | 1 August 2017 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 1 August 2017 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Enasidenib
Clinical summary
Enasidenib is an isocitrate dehydrogenase 2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test. MedsAcross supplies Enasidenib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about EnasidenibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Idhifa prescribing information (Celgene) · U.S. National Library of Medicine, DailyMed
Need Idhifa 100 mg tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.