Medicine
Myleran 2 mg tablet
Myleran 2 mg tablet is a prescription medicine containing Busulfan for oral use, marketed by Waylis Therapeutics, 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 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
Key facts
- Active ingredient (INN)
- Busulfan
- Brand
- Myleran
- Strength
- 2 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 25 tablets
- Marketing authorisation holder
- Waylis Therapeutics
- Manufacturer
- Waylis Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01AB01 Busulfan
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 May 2023
- Identifiers
- RxCUI 105551, 197422DailyMed set ID 2da33e5b-dcfb-4cdf-b163-50398e42f41cNDC 80725-620Application NDA009386
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 |
|---|---|---|---|
| 25 tablet, film coated in 1 bottle | 80725-620-25 | Waylis Therapeutics | 15 May 2023 |
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.
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 Busulfan
Clinical summary
Busulfan is an alkylating drug indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia. It is available as injection and tablets for intravenous and oral use. MedsAcross supplies Busulfan 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 BusulfanFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- MYLERAN prescribing information (Waylis Therapeutics) · U.S. National Library of Medicine, DailyMed
- Busulfan Fresenius Kabi: European public assessment report (EPAR) · European Medicines Agency
Need Myleran 2 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.