Medicine
Cresemba 40 mg capsule
Cresemba 40 mg capsule is a prescription medicine containing Isavuconazonium for oral use, marketed by Astellas Pharma, 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
The prepared infusion solution should be kept for not more than 6 hours at…
Key facts
- Active ingredient (INN)
- Isavuconazonium
- Brand
- Cresemba
- Strength
- 40 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 7 blister pack
- Marketing authorisation holder
- Astellas Pharma
- Manufacturer
- Astellas Pharma
- Origin register
- US FDA, United States
- Storage
- The prepared infusion solution should be kept for not more than 6 hours at room temperature [20°C to 25°C (68°F to 77°F)] or 24 hours at 2°C to 8°C (36°F to 46°F) prior to use. Store CRESEMBA capsules at 20°C to 25°C (68°F to 77°F) in the original packaging to protect from moisture. Excursions are permitted from 15°C to 30°C (59°F to 86°F).
- 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
- 22 November 2022
- Identifiers
- RxCUI 1608327, 1608333, 1608811 +3DailyMed set ID 8f7f73b8-586a-4df0-935f-fecd4696c16cNDC 0469-2860Application NDA207500
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 |
|---|---|---|---|
| 7 blister pack in 1 carton / 5 capsule in 1 blister pack | 0469-2860-35 | Astellas Pharma | 22 November 2022 |
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 6 March 2015 | 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 Isavuconazonium
Clinical summary
Isavuconazonium is an azole antifungal indicated for the treatment of invasive aspergillosis and Invasive mucormycosis, among other approved uses. It is available as capsules and powder for injection for oral and intravenous use. MedsAcross supplies Isavuconazonium 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 IsavuconazoniumFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- CRESEMBA prescribing information (Astellas Pharma) · U.S. National Library of Medicine, DailyMed
Need Cresemba 40 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.