Medicine
AlphaNine SD kit
AlphaNine SD kit is a prescription medicine containing Coagulation factor ix 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. 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
Do not freeze to prevent damage to diluent vial. When removed from…
Key facts
- Active ingredient (INN)
- Coagulation factor ix
- Brand
- AlphaNine SD
- Dosage form
- Kit
- Route
- Intravenous
- Packs
- 1 kit and 3 more
- Marketing authorisation holder
- Grifols
- Manufacturer
- Grifols
- Origin register
- US FDA, United States
- Storage
- Do not freeze to prevent damage to diluent vial. When removed from refrigeration, record the date removed on the space provided on the carton. AlphaNine SD is stable for three years, up to the expiration date printed on its label, provided that the storage temperature is between 2 and 8 °C (36 and 46 °F). May be stored at room temperature not to exceed 30 °C for 1 month.
- 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
- 31 December 1990
- Identifiers
- RxCUI 1666303, 1666309DailyMed set ID 3e99052d-4442-4283-8915-c9a796c77008NDC 68516-3612, 68516-3607, 68516-3610 +3Application BLA103249
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 * 10 mL in 1 vial, single-dose | 68516-3607-2 | Grifols | 31 December 1990 |
| 1 kit in 1 carton * 10 mL in 1 vial * 10 mL in 1 vial, single-dose | 68516-3608-2 | Grifols | 31 December 1990 |
| 1 kit in 1 carton * 10 mL in 1 vial * 10 mL in 1 vial, single-dose | 68516-3609-2 | Grifols | 31 December 1990 |
| 1 kit in 1 carton * 10 mL in 1 vial * 10 mL in 1 vial, glass | 68516-3610-2 | Grifols | 31 December 1990 |
| 1 kit in 1 carton * 10 mL in 1 vial * 10 mL in 1 vial, glass | 68516-3611-2 | Grifols | 31 December 1990 |
| 1 kit in 1 carton * 10 mL in 1 vial * 10 mL in 1 vial, glass | 68516-3612-2 | Grifols | 31 December 1990 |
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 Coagulation factor ix kit.
Clinical summary
Coagulation factor ix is a prescription medicine. It is available as kits for intravenous use. MedsAcross supplies Coagulation factor ix 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 Coagulation factor ixFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- RIXUBIS prescribing information (Takeda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need AlphaNine SD 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.