Medicine
Busulfan 60 mg/10 mL injection
Busulfan 60 mg/10 mL injection is a generic prescription medicine for intravenous use, made by 7 labelers, 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store refrigerated between 2° and 8°C (36° and 46°F).
Key facts
- Active ingredient (INN)
- Busulfan
- Brand
- Sold under the generic name
- Strength
- 60 mg/10 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 8 vials of 10 mL, 8 cartons of 10 mL and 5 more
- Manufacturers
- Accord HealthcareIndiaEugiaIndiaMeitheal PharmaceuticalsAmneal PharmaceuticalsHospiraPharmascienceSagent Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store refrigerated between 2° and 8°C (36° and 46°F).
- Cold chain
- Yes, shipped temperature controlled
- 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 2017
- Identifiers
- RxCUI 253113DailyMed set ID 086a715e-4958-4bb5-9ebd-86171e6b6203, ac9448da-37ad-4609-9aef-eedf8be0f69c, fe0ddd44-ef02-4827-b164-7fcbb45bcc1b +5NDC 25021-241, 70121-1244, 16729-351 +5Application ANDA207050, ANDA209580, ANDA210148 +3
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 8 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 16729-351-92 | Accord HealthcareIndia | 22 July 2019 |
| 8 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 55150-395-08 | EugiaIndia | 25 June 2024 |
| 8 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 71288-116-11 | Meitheal Pharmaceuticals | 23 October 2020 |
| 8 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 71288-158-96 | Meitheal Pharmaceuticals | 23 October 2020 |
| 8 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 70121-1244-7 | Amneal Pharmaceuticals | 18 December 2017 |
| 8 carton in 1 carton / 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 0409-1112-01 | Hospira | 28 February 2019 |
| 8 vial in 1 package / 10 mL in 1 vial | 51817-170-01 | Pharmascience | 19 May 2017 |
| 8 vial in 1 carton / 10 mL in 1 vial | 25021-241-10 | Sagent Pharmaceuticals | 15 May 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.
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 Busulfan 60 mg/10 mL injection 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.