Medicine
Gallium Ga-68 PSMA-11 5 mCi/mL injection
Gallium Ga-68 PSMA-11 5 mCi/mL injection is a prescription medicine containing Gallium ga-68 gozetotide for intravenous use, marketed by Ionetix, 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 Gallium Ga 68 gozetotide injection upright in a lead shielded container…
Key facts
- Active ingredient (INN)
- Gallium ga-68 gozetotide
- Brand
- Gallium Ga-68 PSMA-11
- Strength
- 5 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 9 mL
- Marketing authorisation holder
- Ionetix
- Manufacturer
- Ionetix
- Origin register
- US FDA, United States
- Storage
- Store Gallium Ga 68 gozetotide injection upright in a lead shielded container at 25°C (77°F), excursions are permitted from 15°C to 30°C (59°F to 86°F). Store Gallium Ga 68 gozetotide injection within the original container in radiation shielding.
- 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
- 17 January 2024
- Identifiers
- DailyMed set ID 357655a4-b3ee-4ea1-a1ea-50d4686546bbNDC 71162-201Application ANDA219189
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 |
|---|---|---|---|
| 9 mL in 1 syringe | 71162-201-10 | Ionetix | 17 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 1 December 2020 | 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 Gallium ga-68 gozetotide 5 mCi/mL injection.
Clinical summary
Gallium ga-68 gozetotide is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. It is available as injection for intravenous use. MedsAcross supplies Gallium ga-68 gozetotide 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 Gallium ga-68 gozetotideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Gallium Ga-68 PSMA-11 prescribing information (UCLA Biomedical Cyclotron) · U.S. National Library of Medicine, DailyMed
Need Gallium Ga-68 PSMA-11 5 mCi/mL 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.