Medicine
AFSTYLA Antihemophilic Factor (Recombinant), Single Chain kit
AFSTYLA Antihemophilic Factor (Recombinant), Single Chain kit is a prescription medicine containing Antihemophilic factor, marketed by CSL Behring Lengnau, 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
Store AFSTYLA in powder form at 2°C to 8°C (36°F to 46°F). Do not freeze to…
Key facts
- Active ingredient (INN)
- Antihemophilic factor
- Brand
- AFSTYLA Antihemophilic Factor (Recombinant), Single Chain
- Dosage form
- Kit
- Packs
- 1 kit and 4 more
- Marketing authorisation holder
- CSL Behring Lengnau
- Manufacturer
- CSL Behring Lengnau
- Origin register
- US FDA, United States
- Storage
- Store AFSTYLA in powder form at 2°C to 8°C (36°F to 46°F). Do not freeze to avoid damage to the diluent vial. AFSTYLA can be stored at room temperature, not to exceed 25°C (77°F), for a single period of up to 3 months, within the expiration date printed on the carton and vial labels. Record the starting date of room temperature on the unopened product carton.
- Cold chain
- Yes, shipped temperature controlled
- 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
- 25 May 2016
- Identifiers
- RxCUI 1796379, 1796384DailyMed set ID 51f19873-a63f-4229-9477-5da4ecf31cdeNDC 69911-476, 69911-478, 69911-475 +4Application BLA125591
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 * 2.5 mL in 1 vial, single-use * 2.5 mL in 1 vial, single-use | 69911-474-02 | CSL Behring Lengnau | 25 May 2016 |
| 1 kit in 1 carton * 2.5 mL in 1 vial, single-use * 2.5 mL in 1 vial, single-use | 69911-475-02 | CSL Behring Lengnau | 25 May 2016 |
| 1 kit in 1 carton * 2.5 mL in 1 vial, single-use * 2.5 mL in 1 vial, single-use | 69911-476-02 | CSL Behring Lengnau | 25 May 2016 |
| 1 kit in 1 carton * 5 mL in 1 vial, single-use * 5 mL in 1 vial, single-use | 69911-477-02 | CSL Behring Lengnau | 25 May 2016 |
| 1 kit in 1 carton * 5 mL in 1 vial, single-use * 5 mL in 1 vial, single-use | 69911-478-02 | CSL Behring Lengnau | 25 May 2016 |
| 1 kit in 1 carton * 5 mL in 1 vial, single-use * 5 mL in 1 vial, single-use | 69911-480-02 | CSL Behring Lengnau | 28 March 2017 |
| 1 kit in 1 carton * 5 mL in 1 vial, single-use * 5 mL in 1 vial, single-use | 69911-481-02 | CSL Behring Lengnau | 28 March 2017 |
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.
- Koate kitAvailable on requestKedrion BiopharmaUS FDA12 packs
- 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
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
- DailyMed label record · Checked 12 November 2026
- ALTUVIIIO prescribing information (Bioverativ Therapeutics) · U.S. National Library of Medicine, DailyMed
Need AFSTYLA Antihemophilic Factor (Recombinant), Single Chain 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.