Medicine
Cladribine 10 mg/10 mL injection
Cladribine 10 mg/10 mL injection is a generic prescription medicine for intravenous use, made by 2 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 2° to 8°C (36° to 46°F). Protect from light (keep in outer…
Key facts
- Active ingredient (INN)
- Cladribine
- Brand
- Sold under the generic name
- Strength
- 10 mg/10 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 10 mL
- Manufacturers
- Fresenius KabiHikma Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store refrigerated 2° to 8°C (36° to 46°F). Protect from light (keep in outer carton until time of use).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01BB04 Cladribine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 February 2000
- Identifiers
- RxCUI 240754DailyMed set ID a2592a9b-bca6-4a5a-89c2-855a0634d5fe, 5736aecc-cc1d-47dd-86c0-5fb2e9d70f61NDC 63323-140, 0143-9871Application ANDA076571, ANDA075405
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 / 10 mL in 1 vial, single-dose | 63323-140-10 | Fresenius Kabi | 1 December 2004 |
| 1 vial in 1 box, unit-dose / 10 mL in 1 vial | 0143-9871-01 | Hikma Pharmaceuticals | 28 February 2000 |
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 Cladribine
Clinical summary
Cladribine is a purine antimetabolite indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults, among other approved uses. MedsAcross supplies Cladribine 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 CladribineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Mavenclad prescribing information (EMD Serono) · U.S. National Library of Medicine, DailyMed
- Litak: European public assessment report (EPAR) · European Medicines Agency
- Mavenclad: European public assessment report (EPAR) · European Medicines Agency
Need Cladribine 10 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.