Medicine
Idamycin PFS 10 mg/10 mL injection
Idamycin PFS 10 mg/10 mL injection is a prescription medicine containing Idarubicin for intravenous use, marketed by Pfizer Laboratories, 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 at 2ºC to 8ºC (36ºF to 46ºF). Store and dispense in the…
Key facts
- Active ingredient (INN)
- Idarubicin
- Brand
- Idamycin PFS
- Strength
- 10 mg/10 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 10 mL
- Marketing authorisation holder
- Pfizer Laboratories
- Manufacturer
- Pfizer Laboratories
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2ºC to 8ºC (36ºF to 46ºF). Store and dispense in the original carton until time of use to protect from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01DB06 Idarubicin
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 17 February 1997
- Identifiers
- RxCUI 1791493, 1791495, 1791498 +3DailyMed set ID 0a5a6d93-cc1e-4d7f-8da1-446c134503b3NDC 0013-2586Application NDA050734
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 |
|---|---|---|---|
| 1 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 0013-2586-10 | Pfizer Laboratories | 11 March 2024 |
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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 27 September 1990 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US 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
Alternatives
Other makers and brands of Idarubicin 10 mg/10 mL injection.
Other strengths and forms of Idarubicin
Clinical summary
Idarubicin is an anthracycline topoisomerase inhibitor indicated for the treatment of adult patients with acute myeloid leukemia (AML) as a component of a combination chemotherapy regimen. It is available as injection for intravenous use. MedsAcross supplies Idarubicin 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 IdarubicinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Idamycin PFS prescribing information (Pfizer Laboratories) · U.S. National Library of Medicine, DailyMed
Need Idamycin PFS 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.