Medicine
Papzimeos 500000000000 VP/mL injectable suspension
Papzimeos 500000000000 VP/mL injectable suspension is a prescription medicine containing Zopapogene imadenovec for subcutaneous use, marketed by Precigen, 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
PAPZIMEOS is shipped and stored frozen at ≤ -60°C [≤ -76°F] and should be…
Key facts
- Active ingredient (INN)
- Zopapogene imadenovec
- Brand
- Papzimeos
- Strength
- 500000000000 VP/mL
- Dosage form
- Injectable suspension
- Route
- Subcutaneous
- Packs
- 1 pouch
- Marketing authorisation holder
- Precigen
- Manufacturer
- Precigen
- Origin register
- US FDA, United States
- Storage
- PAPZIMEOS is shipped and stored frozen at ≤ -60°C [≤ -76°F] and should be stored in an appropriate freezer at ≤ -60°C [≤ -76°F] until ready to thaw and administer. DO NOT place the vial in a refrigerator, freezer, or on dry ice at any time once removed from the pouch. PAPZIMEOS should not be held at room temperature for more than 60 minutes after thawing. DO NOT shake the vial.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 15 September 2025
- Identifiers
- RxCUI 2723367, 2723374DailyMed set ID 103db7f1-8540-4bea-935e-217d69e7aa01NDC 84768-511Application BLA125832
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 |
|---|---|---|---|
| 1 pouch in 1 carton / 1 vial in 1 pouch / 1 mL in 1 vial | 84768-511-01 | Precigen | 15 September 2025 |
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
Zopapogene imadenovec is a prescription medicine indicated for the treatment of adults with recurrent respiratory papillomatosis. It is available as injectable suspension for subcutaneous use. MedsAcross supplies Zopapogene imadenovec 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 Zopapogene imadenovecFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- PAPZIMEOS prescribing information (Precigen) · U.S. National Library of Medicine, DailyMed
Need Papzimeos 500000000000 VP/mL injectable suspension 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.