Medicine
Recombinate kit
Recombinate kit is a prescription medicine containing Antihemophilic factor recombinant, marketed by Takeda Pharmaceuticals, 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
RECOMBINATE can be refrigerated [2° - 8°C (36° - 46°F)] or stored at room…
Key facts
- Active ingredient (INN)
- Antihemophilic factor recombinant
- Brand
- Recombinate
- Dosage form
- Kit
- Packs
- 1 kit and 2 more
- Marketing authorisation holder
- Takeda Pharmaceuticals
- Manufacturer
- Takeda Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- RECOMBINATE can be refrigerated [2° - 8°C (36° - 46°F)] or stored at room temperature, not to exceed 30°C (86°F). Avoid freezing to prevent damage to the diluent vial.
- 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
- 10 April 2009
- Identifiers
- RxCUI 1719222, 1719243DailyMed set ID d99348b1-edad-41de-aed9-903a6f9f279fNDC 0944-2843, 0944-2842, 0944-2844 +2Application BLA103375
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 * 10 mL in 1 vial, glass * 5 mL in 1 vial, glass | 0944-2841-10 | Takeda Pharmaceuticals | 10 April 2009 |
| 1 kit in 1 carton * 10 mL in 1 vial, glass * 5 mL in 1 vial, glass | 0944-2842-10 | Takeda Pharmaceuticals | 10 April 2009 |
| 1 kit in 1 carton * 10 mL in 1 vial, glass * 5 mL in 1 vial, glass | 0944-2843-10 | Takeda Pharmaceuticals | 10 April 2009 |
| 1 kit in 1 carton * 10 mL in 1 vial, glass * 5 mL in 1 vial, glass | 0944-2844-10 | Takeda Pharmaceuticals | 15 March 2010 |
| 1 kit in 1 carton * 10 mL in 1 vial, glass * 5 mL in 1 vial, glass | 0944-2845-10 | Takeda Pharmaceuticals | 15 March 2010 |
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 recombinant kit.
Clinical summary
Antihemophilic factor recombinant is a prescription medicine indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes, among other approved uses. It is available as kits. MedsAcross supplies Antihemophilic factor recombinant 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 recombinantFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- RECOMBINATE prescribing information (Takeda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Recombinate 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.