Medicine
Profilnine kit
Profilnine kit is a prescription medicine containing Factor ix complex for intravenous use, marketed by Grifols, 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
Do not freeze. Profilnine is stable for three years, up to the expiration date…
Key facts
- Active ingredient (INN)
- Factor ix complex
- Brand
- Profilnine
- Dosage form
- Kit
- Route
- Intravenous
- Packs
- 1 kit
- Marketing authorisation holder
- Grifols
- Manufacturer
- Grifols
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Profilnine is stable for three years, up to the expiration date printed on its label, provided that the storage temperature does not exceed 25 °C (77 °F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.12Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 20 July 1981
- Identifiers
- RxCUI 1670387, 1670392DailyMed set ID 79821042-86a5-4a64-b621-76de0a0bbab2NDC 68516-3210, 68516-3212, 68516-3211Application BLA102476
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 kit in 1 carton * 5 mL in 1 vial * 5 mL in 1 vial, glass | 68516-3210-1 | Grifols | 20 July 1981 |
| 1 kit in 1 carton * 10 mL in 1 vial * 10 mL in 1 vial, glass | 68516-3211-2 | Grifols | 20 July 1981 |
| 1 kit in 1 carton * 10 mL in 1 vial * 10 mL in 1 vial, glass | 68516-3212-2 | Grifols | 20 July 1981 |
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
Factor ix complex is a prescription medicine indicated for the prevention and control of bleeding in patients with factor IX deficiency (hemophilia B). It is available as kits for intravenous use. MedsAcross supplies Factor ix complex 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 Factor ix complexFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Profilnine prescribing information (Grifols) · U.S. National Library of Medicine, DailyMed
Need Profilnine kit 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.