Medicine
Kesimpta 20 mg/0.4 mL injection
Kesimpta 20 mg/0.4 mL injection is a prescription medicine containing Ofatumumab for subcutaneous use, marketed by Novartis 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
KESIMPTA Sensoready pens and prefilled syringes must be refrigerated at 2ºC to…
Key facts
- Active ingredient (INN)
- Ofatumumab
- Brand
- Kesimpta
- Strength
- 20 mg/0.4 mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Packs
- 1 syringe of 0.4 mL
- Marketing authorisation holder
- Novartis Pharmaceuticals
- Manufacturer
- Novartis Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- KESIMPTA Sensoready pens and prefilled syringes must be refrigerated at 2ºC to 8ºC (36ºF to 46ºF). Do not freeze. Write the date removed from the refrigerator in the space provided on the carton labeling. If necessary, KESIMPTA may be stored for up to 7 days at room temperature, not to exceed 30°C (86°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L01FA02 Ofatumumab
- HS code (indicative)
- 3002.15Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 October 2009
- Identifiers
- RxCUI 2390949, 2390954DailyMed set ID 6a8a3f53-2062-48ff-9dbe-b939df133ca3NDC 0078-1007Application BLA125326
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 / .4 mL in 1 syringe, glass | 0078-1007-68 | Novartis Pharmaceuticals | 20 August 2020 |
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
Clinical summary
Ofatumumab is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. MedsAcross supplies Ofatumumab 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 OfatumumabFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- KESIMPTA prescribing information (Novartis Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Kesimpta: European public assessment report (EPAR) · European Medicines Agency
Need Kesimpta 20 mg/0.4 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.