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MedsAcross

Medicine

Leukeran 2 mg tablet

Chlorambucil · Oral · Waylis Therapeutics
Available on requestPrescription onlyUS FDA Cold chain

Leukeran 2 mg tablet is a prescription medicine containing Chlorambucil 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. It ships in a temperature-controlled cold chain.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Cold chain

Store in a refrigerator, 2° to 8°C (36° to 46°F).

Key facts

Active ingredient (INN)
Chlorambucil
Brand
Leukeran
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 in a refrigerator, 2° to 8°C (36° to 46°F).
Cold chain
Yes, shipped temperature controlled
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
L01AA02 Chlorambucil
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
15 May 2023
Identifiers
RxCUI 105553, 197462DailyMed set ID 58a3c995-5ad6-465d-8437-5970c9088213NDC 80725-610Application NDA010669

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

PackCodeLabelerMarketed since
25 tablet, film coated in 1 bottle80725-610-25Waylis Therapeutics15 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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 18 March 1957Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS 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

Clinical summary

Chlorambucil is an alkylating drug indicated in the treatment of chronic lymphatic (lymphocytic) leukemia, malignant lymphomas including lymphosarcoma, giant follicular lymphoma, and Hodgkin’s disease. It is available as tablets for oral use. MedsAcross supplies Chlorambucil 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 Chlorambucil

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Leukeran 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.