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MedsAcross

Medicine

Testosterone 30 mg/1.5 mL topical solution

Testosterone · Topical
Available on requestPrescription onlyUS FDAControlled, schedule CIIIGeneric name

Testosterone 30 mg/1.5 mL topical solution is a generic prescription medicine for topical use, made by 7 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 upright at 25°C (77°F). Excursions are permitted to 15°C to 30°C (59°F…

Key facts

Active ingredient (INN)
Testosterone
Brand
Sold under the generic name
Strength
30 mg/1.5 mL
Dosage form
Topical solution
Route
Topical
Packs
1 bottle and 5 more
Manufacturers
Alembic PharmaceuticalsIndiaCiplaIndiaLupinIndiaBryant Ranch PrepackActavis PharmaEncube EthicalsPadagis Israel Pharmaceuticals
Origin register
US FDA, United States
Storage
Store upright at 25°C (77°F). Excursions are permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Schedule CIII
ATC code
G03BA03 Testosterone
HS code (indicative)
3004.39Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
28 June 2017
Identifiers
RxCUI 1599949DailyMed set ID 6a46b5de-5d95-4570-91a6-3e4278028c59, 29c8846f-121c-4958-9e03-3bd271c21558, ca5d4865-356b-45e7-b603-fe299e450abc +5NDC 69097-363, 68180-943, 21922-109 +5Application ANDA209533, ANDA208061, ANDA212301 +3

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, with applicator in 1 carton / 110 mL in 1 bottle, with applicator62332-488-11Alembic PharmaceuticalsIndia8 December 2021
1 bottle in 1 carton / 90 mL in 1 bottle69097-363-44CiplaIndia30 March 2018
1 bottle, with applicator in 1 carton / 90 mL in 1 bottle, with applicator68180-943-11LupinIndia23 February 2018
1 bottle, with applicator in 1 carton / 90 mL in 1 bottle, with applicator0591-2114-81Actavis Pharma18 August 2017
1 bottle in 1 carton / 110 mL in 1 bottle21922-109-16Encube Ethicals19 June 2026
1 bottle, pump in 1 carton / 110 mL in 1 bottle, pump45802-610-01Padagis Israel Pharmaceuticals28 June 2017
1 bottle, pump in 1 carton / 110 mL in 1 bottle, pump63629-9310-1Bryant Ranch Prepack6 July 2022
1 bottle, pump in 1 carton / 110 mL in 1 bottle, pump72162-1421-2Bryant Ranch Prepack11 January 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.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 12 October 1993Drugs@FDA
EU (EMA)WithdrawnEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenWithdrawnEuropean 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 Testosterone

Clinical summary

Testosterone is an androgen indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. It is available as gel, topical solution and implant pellets for transdermal and nasal use. MedsAcross supplies Testosterone 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 Testosterone

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

Data sources

Need Testosterone 30 mg/1.5 mL topical 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.