Medicine
Tobi 300 mg/5 mL inhalation solution
Tobi 300 mg/5 mL inhalation solution is a prescription medicine containing Tobramycin for inhalation, oral use, marketed by Viatris Specialty, 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
TOBI should be stored under refrigeration at 2ºC-8ºC/36ºF-46ºF. Upon removal…
Key facts
- Active ingredient (INN)
- Tobramycin
- Brand
- Tobi
- Strength
- 300 mg/5 mL
- Dosage form
- Inhalation solution
- Route
- Inhalation, oral
- Packs
- 56 pouches
- Marketing authorisation holder
- Viatris Specialty
- Manufacturer
- Viatris Specialty
- Origin register
- US FDA, United States
- Storage
- TOBI should be stored under refrigeration at 2ºC-8ºC/36ºF-46ºF. Upon removal from the refrigerator, or if refrigeration is unavailable, TOBI pouches (opened or unopened) may be stored at room temperature (up to 25ºC/77ºF) for up to 28 days.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J01GB01 Tobramycin
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 June 2022
- Identifiers
- RxCUI 213194, 348719DailyMed set ID 6a3c3871-1d3a-44d6-8be3-526b30123ef7NDC 49502-345Application NDA050753
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 |
|---|---|---|---|
| 56 pouch in 1 carton / 14 ampule in 1 pouch / 5 mL in 1 ampule | 49502-345-74 | Viatris Specialty | 25 June 2026 |
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
Alternatives
Other makers and brands of Tobramycin 300 mg/5 mL inhalation solution.
- Tobramycin 300 mg/5 mL inhalation solutionAvailable on request—US FDA10 packs Cold chain
- Kitabis Pak 300 mg/5 mL inhalation solutionAvailable on requestPari Respiratory EquipmentUS FDA1 pack Cold chain
- Tobramycin Inhalation Solution Pak 300 mg/5 mL inhalation solutionAvailable on requestGenericusUS FDA1 pack Cold chain
Other strengths and forms of Tobramycin
Clinical summary
Tobramycin is an aminoglycoside antibacterial indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. It is available as inhalation solution, eye drops and injection for ophthalmic and intravenous use. MedsAcross supplies Tobramycin 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 TobramycinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- TOBREX prescribing information (Novartis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Tobi Podhaler: European public assessment report (EPAR) · European Medicines Agency
- Vantobra (previously Tobramycin PARI): European public assessment report (EPAR) · European Medicines Agency
Need Tobi 300 mg/5 mL inhalation solution 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.