Medicine
Mutamycin 40 mg/80 mL powder for injection
Mutamycin 40 mg/80 mL powder for injection is a prescription medicine containing Mitomycin for intravenous use, marketed by Accord BioPharma, 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 solution under refrigeration 2° to 8 °C (36° to 46°F), discard after 14…
Key facts
- Active ingredient (INN)
- Mitomycin
- Brand
- Mutamycin
- Strength
- 40 mg/80 mL
- Dosage form
- Powder for injection
- Route
- Intravenous
- Packs
- 1 vial
- Marketing authorisation holder
- Accord BioPharma
- Manufacturer
- Accord BioPharmaIndia
- Origin register
- US FDA, United States
- Storage
- Store solution under refrigeration 2° to 8 °C (36° to 46°F), discard after 14 days. Store dry powder at 25°C, excursion permitted between 15°C and 30°C, protected from light. Avoid excessive heat, over 40 °C (104° F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 July 2017
- Identifiers
- RxCUI 1740894, 1740898, 1740900 +3DailyMed set ID cbf0f6ba-3a53-4791-9a85-5c6b271eeb8eNDC 69448-001, 69448-003Application ANDA064144
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 in 1 carton / 10 mL in 1 vial | 69448-001-05 | Accord BioPharmaIndia | 25 July 2017 |
| 1 vial in 1 box, unit-dose / 80 mL in 1 vial | 69448-003-38 | Accord BioPharmaIndia | 25 July 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 14 November 2002 | 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
Other strengths and forms of Mitomycin
Clinical summary
Mitomycin is an alkylating drug indicated as an adjunct to ab externo glaucoma surgery. It is available as powder for injection and kits for intravenous use. MedsAcross supplies Mitomycin 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 MitomycinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Mitosol prescribing information (Mobius Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Mutamycin 40 mg/80 mL powder for 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.