Medicine
Provenge 50000000 injection
Provenge 50000000 injection is a prescription medicine containing Sipuleucel-t for intravenous use, marketed by Dendreon 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
The insulated container and gel packs within the container are designed to…
Key facts
- Active ingredient (INN)
- Sipuleucel-t
- Brand
- Provenge
- Strength
- 50000000
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 bag
- Marketing authorisation holder
- Dendreon Pharmaceuticals
- Manufacturer
- Dendreon Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- The insulated container and gel packs within the container are designed to maintain the appropriate transportation and storage temperature of PROVENGE until infusion.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L03AX17 Sipuleucel-t
- HS code (indicative)
- 3002.51Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 29 April 2010
- Identifiers
- RxCUI 997264, 997267DailyMed set ID 8309b497-5d4e-4408-ac0c-2452c11c8a35NDC 30237-8900Application BLA125197
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 bag in 1 carton / 1 injection in 1 bag | 30237-8900-6 | Dendreon Pharmaceuticals | 29 April 2010 |
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
Sipuleucel-t is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. It is available as injection for intravenous use. MedsAcross supplies Sipuleucel-t 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 Sipuleucel-tFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- PROVENGE prescribing information (Dendreon Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Provenge 50000000 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.