Medicine
Alphanate kit
Alphanate kit is a prescription medicine containing Antihemophilic factor/von willebrand factor 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. ALPHANATE is stable for three years, up to the expiration date…
Key facts
- Active ingredient (INN)
- Antihemophilic factor/von willebrand factor complex
- Brand
- Alphanate
- Dosage form
- Kit
- Route
- Intravenous
- Packs
- 1 kit and 2 more
- Marketing authorisation holder
- Grifols
- Manufacturer
- Grifols
- Origin register
- US FDA, United States
- Storage
- Do not freeze. ALPHANATE 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
- 15 August 1978
- Identifiers
- RxCUI 1661332, 1661345DailyMed set ID 5a7aea94-654c-4113-9014-c3137de0a931NDC 68516-4620, 68516-4616, 68516-4618 +2Application BLA102475
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 | 68516-4616-1 | Grifols | 15 August 1978 |
| 1 kit in 1 carton * 5 mL in 1 vial * 5 mL in 1 vial, glass | 68516-4617-1 | Grifols | 15 August 1978 |
| 1 kit in 1 carton * 10 mL in 1 vial * 10 mL in 1 vial, glass | 68516-4618-2 | Grifols | 15 August 1978 |
| 1 kit in 1 carton * 10 mL in 1 vial * 10 mL in 1 vial, glass | 68516-4619-2 | Grifols | 15 August 1978 |
| 1 kit in 1 carton * 10 mL in 1 vial * 10 mL in 1 vial, glass | 68516-4620-2 | Grifols | 26 June 2014 |
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
Alternatives
Other makers and brands of Antihemophilic factor/von willebrand factor complex kit.
Clinical summary
Antihemophilic factor/von willebrand factor complex is a prescription medicine indicated for treatment and prevention of bleeding episodes and perioperative management in adult, among other approved uses. MedsAcross supplies Antihemophilic factor/von willebrand factor 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 Antihemophilic factor/von willebrand factor 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
- Alphanate prescribing information (Grifols) · U.S. National Library of Medicine, DailyMed
Need Alphanate 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.