Medicine
Pylarify 80 mCi/mL injection
Pylarify 80 mCi/mL injection is a prescription medicine containing Piflufolastat f-18 for intravenous use, marketed by Progenics 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 PYLARIFY at controlled room temperature (USP) 20°C to 25°C (68°F to…
Key facts
- Active ingredient (INN)
- Piflufolastat f-18
- Brand
- Pylarify
- Strength
- 80 mCi/mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 50 mL
- Marketing authorisation holder
- Progenics Pharmaceuticals
- Manufacturer
- Progenics Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store PYLARIFY at controlled room temperature (USP) 20°C to 25°C (68°F to 77°F). Store PYLARIFY in the original container with 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
- 26 May 2021
- Identifiers
- DailyMed set ID a00e5cbc-4fd5-4280-82ec-cd3498df4553NDC 71258-022Application NDA214793
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 |
|---|---|---|---|
| 50 mL in 1 vial, multi-dose | 71258-022-01 | Progenics Pharmaceuticals | 26 May 2021 |
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 26 May 2021 | 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
Other strengths and forms of Piflufolastat f-18
Clinical summary
Piflufolastat 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. It is available as injection for intravenous use. MedsAcross supplies Piflufolastat 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 Piflufolastat 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
- PYLARIFY prescribing information (Progenics Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Pylarify 80 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.