Medicine
Ensacove 100 mg capsule
Ensacove 100 mg capsule is a prescription medicine containing Ensartinib for oral use, marketed by Xcovery Holdings, 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 controlled room temperature 20ºC to 25ºC (68ºF to 77ºF), excursions…
Key facts
- Active ingredient (INN)
- Ensartinib
- Brand
- Ensacove
- Strength
- 100 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 60 capsules
- Marketing authorisation holder
- Xcovery Holdings
- Manufacturer
- Xcovery Holdings
- Origin register
- US FDA, United States
- Storage
- Store at controlled room temperature 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). Store and dispense in the original bottle with desiccant to protect from moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 30 April 2025
- Identifiers
- RxCUI 2712634, 2712640, 2712642 +1DailyMed set ID 1e1b2f79-678a-472a-b924-66909c8a4b2eNDC 83076-1100Application NDA218171
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 |
|---|---|---|---|
| 60 capsule in 1 bottle | 83076-1100-6 | Xcovery Holdings | 30 April 2025 |
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 18 December 2024 | Drugs@FDA |
| EU (EMA) | Opinion | EMA medicines data |
| 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 Ensartinib
Clinical summary
Ensartinib is a prescription medicine indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)as detected by an FDA-approved test, among other approved uses. MedsAcross supplies Ensartinib 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 EnsartinibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ENSACOVE prescribing information (Xcovery Holdings) · U.S. National Library of Medicine, DailyMed
Need Ensacove 100 mg capsule 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.