Medicine
Posluma 158 mCi/mL injection
Posluma 158 mCi/mL injection is a prescription medicine containing Flotufolastat f-18 for intravenous use, marketed by Blue Earth Diagnostics, 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 POSLUMA at 20°C to 25°C (68°F to 77°F). Store POSLUMA in the original…
Key facts
- Active ingredient (INN)
- Flotufolastat f-18
- Brand
- Posluma
- Strength
- 158 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 25 mL
- Marketing authorisation holder
- Blue Earth Diagnostics
- Manufacturer
- Blue Earth Diagnostics
- Origin register
- US FDA, United States
- Storage
- Store POSLUMA at 20°C to 25°C (68°F to 77°F). Store POSLUMA in 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
- 25 May 2023
- Identifiers
- DailyMed set ID 907ac4a4-a088-4826-ab50-cfc31985c9d4NDC 69932-002Application NDA216023
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 |
|---|---|---|---|
| 25 mL in 1 vial, multi-dose | 69932-002-50 | Blue Earth Diagnostics | 25 May 2023 |
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 |
| 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
Clinical summary
Flotufolastat f-18 is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy. MedsAcross supplies Flotufolastat f-18 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 Flotufolastat f-18For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- POSLUMA prescribing information (Blue Earth Diagnostics) · U.S. National Library of Medicine, DailyMed
Need Posluma 158 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.