Medicine
Pixclara 300 mCi/mL injection
Pixclara 300 mCi/mL injection is a prescription medicine containing Floretyrosine f-18 for intravenous use, marketed by Telix Pharmaceuticals, 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 PIXCLARA at 15°C to 25°C (59°F to 77°F) upright in the original…
Key facts
- Active ingredient (INN)
- Floretyrosine f-18
- Brand
- Pixclara
- Strength
- 300 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 30 mL
- Marketing authorisation holder
- Telix Pharmaceuticals
- Manufacturer
- Telix Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store PIXCLARA at 15°C to 25°C (59°F to 77°F) upright in the original container with radiation shielding.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- V09IX10 Floretyrosine f-18
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 11 September 2026
- Identifiers
- DailyMed set ID dc78b128-3768-4448-b019-61574db05714NDC 74725-338Application NDA218592
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 |
|---|---|---|---|
| 30 mL in 1 vial, multi-dose | 74725-338-30 | Telix Pharmaceuticals | 11 September 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.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 11 September 2026 | 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
Clinical summary
Floretyrosine f-18 is a prescription medicine indicated with positron emission tomography (PET) to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults, among other approved uses. MedsAcross supplies Floretyrosine 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 Floretyrosine 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
- PIXCLARA prescribing information (Telix Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Pixclara 300 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.