Medicine
Xyntha kit
Xyntha kit is a prescription medicine containing Antihemophilic factor, marketed by Wyeth 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. 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 XYNTHA under refrigeration at a temperature of 2° to 8°C (36° to 46°F)…
Key facts
- Active ingredient (INN)
- Antihemophilic factor
- Brand
- Xyntha
- Dosage form
- Kit
- Packs
- 1 kit and 6 more
- Marketing authorisation holder
- Wyeth BioPharma
- Manufacturer
- Wyeth BioPharma
- Origin register
- US FDA, United States
- Storage
- Store XYNTHA under refrigeration at a temperature of 2° to 8°C (36° to 46°F) for up to 36 months from the date of manufacture until the expiration date stated on the label. • Within the expiration date, XYNTHA also may be stored at room temperature not to exceed 25°C (77°F) for up to 3 months. • After room temperature storage, XYNTHA can be returned to the refrigerator until the expiration date.
- 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
- 1 August 2008
- Identifiers
- RxCUI 797544, 1718993, 1718996 +2DailyMed set ID 52e97c7f-8240-4cd6-afd2-c452ab2f6e32, 25ea1c3c-14a2-ef11-302e-012bd683924fNDC 58394-015, 58394-023, 58394-024 +6Application BLA125264
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 * 4 mL in 1 vial, single-use * 4 mL in 1 syringe * 1 mL in 1 packet | 58394-012-01 | Wyeth BioPharma | 1 August 2008 |
| 1 kit in 1 carton * 4 mL in 1 syringe * 1 mL in 1 packet * 4 mL in 1 vial, single-use | 58394-013-01 | Wyeth BioPharma | 1 August 2008 |
| 1 kit in 1 carton * 4 mL in 1 syringe * 1 mL in 1 packet * 4 mL in 1 vial, single-use | 58394-014-01 | Wyeth BioPharma | 1 August 2008 |
| 1 kit in 1 carton * 1 mL in 1 packet * 4 mL in 1 vial, single-use * 4 mL in 1 syringe | 58394-015-01 | Wyeth BioPharma | 1 August 2008 |
| 1 kit in 1 carton * 4 mL in 1 syringe * 1 mL in 1 packet | 58394-016-03 | Wyeth BioPharma | 13 August 2010 |
| 1 kit in 1 carton * 4 mL in 1 syringe * 1 mL in 1 packet | 58394-022-03 | Wyeth BioPharma | 1 December 2011 |
| 1 kit in 1 carton * 4 mL in 1 syringe * 1 mL in 1 packet | 58394-023-03 | Wyeth BioPharma | 1 December 2011 |
| 1 kit in 1 carton * 4 mL in 1 syringe * 1 mL in 1 packet | 58394-024-03 | Wyeth BioPharma | 1 August 2011 |
| 1 kit in 1 carton * 4 mL in 1 syringe * 1 mL in 1 packet | 58394-025-03 | Wyeth BioPharma | 1 August 2011 |
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
- 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
- DailyMed label record · Checked 12 November 2026
- ALTUVIIIO prescribing information (Bioverativ Therapeutics) · U.S. National Library of Medicine, DailyMed
Need Xyntha 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.