Medicine
Koate kit
Koate kit is a prescription medicine containing Antihemophilic factor for intravenous use, marketed by Kedrion Biopharma, 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
Storage as on the product label
Key facts
- Active ingredient (INN)
- Antihemophilic factor
- Brand
- Koate
- Dosage form
- Kit
- Route
- Intravenous
- Packs
- 1 kit and 9 more
- Marketing authorisation holder
- Kedrion Biopharma
- Manufacturer
- Kedrion Biopharma
- Origin register
- US FDA, United States
- 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 May 1999
- Identifiers
- NDC 76125-253, 76125-258, 76125-674 +9Application BLA101130
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, glass * 5 mL in 1 vial, glass | 76125-253-25 | Kedrion Biopharma | 20 May 1999 |
| 1 kit in 1 carton * 5 mL in 1 vial, glass * 5 mL in 1 vial, glass | 76125-257-25 | Kedrion Biopharma | 20 May 1999 |
| 1 kit in 1 carton * 5 mL in 1 vial, glass * 5 mL in 1 vial, glass | 76125-258-02 | Kedrion Biopharma | 20 May 1999 |
| 1 kit in 1 carton * 5 mL in 1 vial, glass * 5 mL in 1 vial, glass | 76125-259-02 | Kedrion Biopharma | 20 May 1999 |
| 1 kit in 1 carton * 5 mL in 1 vial, glass * 5 mL in 1 vial, glass | 76125-661-02 | Kedrion Biopharma | 20 May 1999 |
| 1 kit in 1 carton * 5 mL in 1 vial, glass * 5 mL in 1 vial, glass | 76125-662-50 | Kedrion Biopharma | 20 May 1999 |
| 1 kit in 1 carton * 5 mL in 1 vial, glass * 5 mL in 1 vial, glass | 76125-663-50 | Kedrion Biopharma | 20 May 1999 |
| 1 kit in 1 carton * 5 mL in 1 vial, glass * 5 mL in 1 vial, glass | 76125-665-02 | Kedrion Biopharma | 20 May 1999 |
| 1 kit in 1 carton * 10 mL in 1 vial, glass * 10 mL in 1 vial, glass | 76125-674-10 | Kedrion Biopharma | 20 May 1999 |
| 1 kit in 1 carton * 10 mL in 1 vial, glass * 10 mL in 1 vial, glass | 76125-675-12 | Kedrion Biopharma | 20 May 1999 |
| 1 kit in 1 carton * 10 mL in 1 vial, glass * 10 mL in 1 vial, glass | 76125-678-10 | Kedrion Biopharma | 20 May 1999 |
| 1 kit in 1 carton * 10 mL in 1 vial, glass * 10 mL in 1 vial, glass | 76125-679-12 | Kedrion Biopharma | 20 May 1999 |
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 kit.
- Eloctate kitAvailable on requestBioverativ TherapeuticsUS FDA10 packs
- Esperoct kitAvailable on requestNovo NordiskUS FDA10 packs Cold chain
- Kovaltry kitAvailable on requestBayer HealthCareUS FDA10 packs Cold chain
- Xyntha kitAvailable on requestWyeth BioPharmaUS FDA9 packs Cold chain
- Nuwiq kitAvailable on requestOctapharmaUS FDA8 packs
- AFSTYLA Antihemophilic Factor (Recombinant), Single Chain kitAvailable on requestCSL Behring LengnauUS FDA7 packs Cold chain
Clinical summary
Antihemophilic factor is a prescription medicine. It is available as kits for intravenous use. MedsAcross supplies Antihemophilic factor 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 factorFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- US FDA NDC directory · Checked 12 November 2026
- ALTUVIIIO prescribing information (Bioverativ Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Koate 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.