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Medicine

Tobramycin 3 mg/mL eye drops

Tobramycin · Ophthalmic
Available on requestPrescription onlyUS FDAGeneric name

Tobramycin 3 mg/mL eye drops is a generic prescription medicine for ophthalmic use, made by 14 labelers, 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

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 2° - 25°C (36° - 77°F).

Key facts

Active ingredient (INN)
Tobramycin
Brand
Sold under the generic name
Strength
3 mg/mL
Dosage form
Eye drops
Route
Ophthalmic
Packs
1 bottle, 5 mL and 14 more
Manufacturers
Alembic PharmaceuticalsIndiaGland PharmaIndiaProficient RxA-S Medication SolutionsAsclemedBelcher PharmaceuticalsDirectRxJvet PharmaceuticalsNuCare Pharmaceuticals,IncPreferred Pharmaceuticals
Origin register
US FDA, United States
Storage
Store at 2° - 25°C (36° - 77°F).
Cold chain
Not required on record
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
31 January 1996
Identifiers
RxCUI 313415DailyMed set ID 5564e780-2320-4ce7-b211-806ca99110c3, 17b5b083-79ab-46b5-bed6-866e5415c623, 3c23234a-452b-40d0-922f-37e49147d537 +13NDC 76420-092, 62250-110, 62332-518 +13Application ANDA207444, ANDA212628, ANDA211847 +1

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

Packs from every labeler of this generic presentation.

PackCodeLabelerMarketed since
1 bottle in 1 carton / 5 mL in 1 bottle46708-518-05Alembic PharmaceuticalsIndia19 April 2019
1 bottle in 1 carton / 5 mL in 1 bottle62332-518-05Alembic PharmaceuticalsIndia19 April 2019
1 bottle, plastic in 1 carton / 5 mL in 1 bottle, plastic68083-374-01Gland PharmaIndia9 March 2021
1 bottle, plastic in 1 carton / 5 mL in 1 bottle, plastic62250-110-01Belcher Pharmaceuticals1 April 2024
1 bottle, plastic in 1 carton / 5 mL in 1 bottle, plastic86211-110-01Jvet Pharmaceuticals26 January 2026
1 bottle in 1 carton / 5 mL in 1 bottle70069-131-01Somerset Therapeutics11 August 2020
1 bottle, dropper in 1 carton / 2 mL in 1 bottle, dropper63187-902-02Proficient Rx1 September 2017
1 bottle, dropper in 1 carton / 5 mL in 1 bottle, dropper63187-902-05Proficient Rx1 September 2017
1 bottle in 1 carton / 5 mL in 1 bottle71205-101-05Proficient Rx4 September 2018
1 bottle in 1 carton / 5 mL in 1 bottle50090-4190-0A-S Medication Solutions11 August 2020
5 mL in 1 bottle76420-092-05Asclemed24 October 2020
5 mL in 1 bottle61919-642-05DirectRX23 April 2019
1 bottle in 1 carton / 5 mL in 1 bottle68071-2272-5NuCare Pharmaceuticals,Inc7 October 2020
1 bottle in 1 carton / 5 mL in 1 bottle68788-7252-5Preferred Pharmaceuticals29 August 2018
1 bottle in 1 carton / 5 mL in 1 bottle70518-1370-0Remedyrepack13 August 2018
1 bottle in 1 carton / 5 mL in 1 bottle85766-189-05Sportpharm20 March 2026
1 bottle in 1 carton / 5 mL in 1 bottle60760-583-05St. Mary's Medical Park Pharmacy12 September 2019

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 11 June 1975Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
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

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 Tobramycin

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

Data sources

Need Tobramycin 3 mg/mL eye drops 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.