Mitosol kit is a prescription medicine containing Mitomycin, marketed by Mobius 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store kits at 20°C to 25°C (68°F to 77°F). Protect from light.
Key facts
- Active ingredient (INN)
- Mitomycin
- Brand
- Mitosol
- Dosage form
- Kit
- Packs
- 3 trays
- Marketing authorisation holder
- Mobius Therapeutics
- Manufacturer
- Mobius Therapeutics
- Origin register
- US FDA, United States
- Storage
- Store kits at 20°C to 25°C (68°F to 77°F). Protect from light.
- Cold chain
- Not required on record
- 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
- 8 February 2012
- Identifiers
- RxCUI 1244553, 1244558DailyMed set ID 244002c6-c61d-43fe-9326-072797113979NDC 49771-002Application NDA022572
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 |
|---|---|---|---|
| 3 tray in 1 carton / 1 kit in 1 tray * 1 mL in 1 vial, single-use * 1 mL in 1 syringe, glass | 49771-002-03 | Mobius Therapeutics | 8 February 2012 |
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
Alternatives
Other makers and brands of Mitomycin kit.
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 Mitosol kit 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.