Medicine
Saphnelo 120 mg/0.8 mL injection
Saphnelo 120 mg/0.8 mL injection is a prescription medicine containing Anifrolumab for subcutaneous use, marketed by AstraZeneca 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
Store SAPHNELO in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original…
Key facts
- Active ingredient (INN)
- Anifrolumab
- Brand
- Saphnelo
- Strength
- 120 mg/0.8 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 syringe of 0.8 mL
- Marketing authorisation holder
- AstraZeneca Pharmaceuticals
- Manufacturer
- AstraZeneca Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store SAPHNELO in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. • Do not freeze. After the SAPHNELO prefilled syringe or autoinjector has reached room temperature, do not return to the refrigerator. If needed, SAPHNELO prefilled syringe or autoinjector can be stored at room temperature 68°F to 77°F (20°C to 25°C) for up to 7 days protected from light.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AG11 Anifrolumab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 24 April 2026
- Identifiers
- RxCUI 2565280, 2565286, 2741470 +3DailyMed set ID d6203302-2128-41a7-b0b4-0e6c0704d4dcNDC 0310-3080Application BLA761451
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 syringe, glass in 1 carton / .8 mL in 1 syringe, glass | 0310-3080-01 | AstraZeneca Pharmaceuticals | 24 April 2026 |
| 1 syringe, glass in 1 carton / .8 mL in 1 syringe, glass | 0310-3080-02 | AstraZeneca Pharmaceuticals | 24 April 2026 |
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.
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
Other strengths and forms of Anifrolumab
Clinical summary
Anifrolumab is a type I interferon receptor antagonist indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. MedsAcross supplies Anifrolumab 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 AnifrolumabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- SAPHNELO prescribing information (AstraZeneca Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Saphnelo: European public assessment report (EPAR) · European Medicines Agency
Need Saphnelo 120 mg/0.8 mL injection 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.