Medicine
Clofarabine 20 mg/20 mL injection
Clofarabine 20 mg/20 mL injection is a generic prescription medicine for intravenous use, made by 9 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not freeze. The pH range of the solution is 4.5 to 7.5 and is supplied as…
Key facts
- Active ingredient (INN)
- Clofarabine
- Brand
- Sold under the generic name
- Strength
- 20 mg/20 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 20 mL and 6 more
- Manufacturers
- Dr. Reddy's LaboratoriesIndiaEugiaIndiaGland PharmaIndiaNovadoz PharmaceuticalsIndiaZydus LifesciencesIndiaAmneal PharmaceuticalsFosun PharmaFresenius KabiMeitheal Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not freeze. The pH range of the solution is 4.5 to 7.5 and is supplied as follows: 20 mg per 20 mL (1 mg/mL) 20 mL Single-Dose Vials Packaged Individually NDC 55150-326-01 Vials containing undiluted Clofarabine Injection should be stored at 25°C (77°F), excursions permitted to 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
- ATC code
- L01BB06 Clofarabine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 May 2017
- Identifiers
- RxCUI 486419DailyMed set ID 18adf4af-63ed-41e6-ab59-87085ce3e5fb, b7d3a96e-0280-4f14-b921-795996f75950, e956b1e0-2829-4872-8c09-99462d60e922 +6NDC 55150-326, 68083-386, 72266-108 +6Application ANDA212457, ANDA207831, ANDA204029 +4
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 |
|---|---|---|---|
| 1 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 43598-309-20 | Dr. Reddy's LaboratoriesIndia | 8 November 2017 |
| 1 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 55150-326-01 | EugiaIndia | 3 October 2022 |
| 1 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 68083-386-01 | Gland PharmaIndia | 14 November 2018 |
| 1 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 72205-394-01 | Novadoz PharmaceuticalsIndia | 1 September 2026 |
| 1 vial, single-use in 1 carton / 20 mL in 1 vial, single-use | 49315-003-06 | Zydus LifesciencesIndia | 10 May 2017 |
| 1 vial, single-dose in 1 box / 20 mL in 1 vial, single-dose | 70121-1236-1 | Amneal Pharmaceuticals | 6 November 2017 |
| 1 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 72266-108-01 | Fosun Pharma | 19 August 2019 |
| 1 vial, single-use in 1 carton / 20 mL in 1 vial, single-use | 63323-572-70 | Fresenius Kabi | 10 May 2017 |
| 1 vial, single-dose in 1 carton / 20 mL in 1 vial, single-dose | 71288-128-20 | Meitheal Pharmaceuticals | 23 October 2020 |
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
Clinical summary
Clofarabine is a nucleoside metabolic inhibitor indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. MedsAcross supplies Clofarabine 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 ClofarabineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- CLOFARABINE prescribing information (Novadoz Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Evoltra: European public assessment report (EPAR) · European Medicines Agency
Need Clofarabine 20 mg/20 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.