Kesimpta (ofatumumab) is a monthly, self-injected anti-CD20 antibody for relapsing multiple sclerosis, and what an importer needs is a verified cold chain and the destination registration route, not a generic to source.
M Care Exports supplies Kesimpta (ofatumumab), the Novartis subcutaneous anti-CD20 antibody for relapsing forms of multiple sclerosis, in 20 mg/0.4 mL presentations. M Care is a merchant exporter: we source the originator brand through licensed channels and dispatch on quote, in 2 to 8 degree Celsius lanes, not from our own manufacturing.
Ofatumumab exporter and bulk supplier from India.
"I'm looking for Kesimpta for a neurology service" and "We need a partner for a refrigerated biologic" are how these requests usually arrive. For hospital pharmacy, MoH and tender-desk orders, and for licensed importers and distributors, M Care quotes ofatumumab against the buyer's specification: the 20 mg/0.4 mL pre-filled pen or, where the destination market authorises it, the pre-filled syringe, the pack size and the quantity per delivery. Kesimpta is a specialist-prescribed biologic, so we confirm the destination's registration route, the importer's cold-chain handling capability and the pack and leaflet language before a quote. Each quote is built per destination, because registration route, pack format and freight lane differ between the UAE, Nigeria, the UK and other markets.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Anti-CD20 monoclonal antibody (disease-modifying therapy for relapsing multiple sclerosis), sourced and documented for export.
Ofatumumab is a monoclonal antibody that targets CD20 on B cells. Kesimpta is given by subcutaneous injection: 20 mg at weeks 0, 1 and 2, then 20 mg once monthly from week 4, as stated in both the US label and the UK SmPC. The FDA label lists relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The EU and UK wording is adults with relapsing forms of MS with active disease defined by clinical or imaging features. The US label lists a single-dose Sensoready Pen and a single-dose pre-filled syringe, each delivering 20 mg/0.4 mL. The UK SmPC describes a pre-filled pen in a single-pen pack and a multipack of three, noting that not every pack size may be marketed. The EMA record describes a solution for injection in pre-filled syringes or pre-filled pens. It needs no reconstitution. The first injection is given under healthcare professional guidance (US label), and later doses are self-administered at home, which shapes how hospitals and importers plan supply.
Active ingredient
Ofatumumab. Anti-CD20 monoclonal antibody (disease-modifying therapy for relapsing multiple sclerosis).
Forms and strengths
20 mg/0.4 mL solution for injection in pre-filled pen; 20 mg/0.4 mL solution for injection in pre-filled syringe.
Indications
Ofatumumab, a CD20-directed monoclonal antibody given by subcutaneous injection for relapsing forms of multiple sclerosis in adults. Supplied as the originator brand Kesimpta in cold-chain lanes to regulated and semi-regulated markets outside India.
Administration
Subcutaneous. Solution for injection in a pre-filled pen or pre-filled syringe.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers are hospital neurology and MS-service pharmacies, MoH and public-hospital tender desks that list disease-modifying MS therapies, licensed importers and distributors who hold the destination registration and cold-chain storage, and private hospital groups in the GCC, Africa and the UK. Because Kesimpta is prescribed by specialists and dispensed for home injection, the buyer is usually a hospital or specialist pharmacy, not a general retailer. A typical request reads: I'm looking for Kesimpta 20 mg pens for a named-patient programme, or we need a partner for a refrigerated MS biologic across several hospital sites. India is not a served market.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on ofatumumab.
For the pharmacist, the practical points are these. Dosing is a fixed 20 mg: weeks 0, 1 and 2, then monthly from week 4, so a new patient's first month needs four pens or syringes, and later months one. Storage is 2 to 8 degrees Celsius in the original carton, protected from light, and never frozen or shaken (US label). The UK SmPC permits, if necessary, a single unrefrigerated period of up to 7 days at room temperature (not above 30 degrees Celsius), and this should be written into the dispatch and receiving record. The UK SmPC gives a shelf life of 3 years. Vaccination planning matters: the UK SmPC advises live or live-attenuated vaccines at least 4 weeks before starting and inactivated vaccines, whenever possible, at least 2 weeks before; live vaccines are not recommended during treatment or until B-cell repletion. Hepatitis B screening is required in the US label, which also contraindicates active HBV infection. Infection and injection-related reactions are the usual counselling points.
The documentation pack a regulator actually asks for.
Ofatumumab is a refrigerated biologic, so the shipping pack must show a validated 2 to 8 degree Celsius lane with in-transit temperature logging and an on-arrival record. The labelled room-temperature allowance is a patient-use provision, and M Care does not use it to plan transit. The originator product carries labelling that differs by market: the US label lists a pen and a syringe and a 6-month contraception window after the last dose, while the UK SmPC describes the pen and a 2-month window. We therefore match the pack and leaflet to the destination's approved text rather than a single global version. UAE product registration sits with the Emirates Drug Establishment (EDE), and Nigerian, Kenyan, Ghanaian and other African registrations are national. Whether Kesimpta is registered in a specific destination is something we check with the importer per quote, as we have not verified it from regulator pages for every market. We provide batch certificates, import documentation and CTD-format support where a regulator asks for a dossier. M Care holds ISO 9001:2015 for its trading entity and does not claim manufacturer status.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside ofatumumab.
Ocrelizumab
CD20-directed antibody · relapsing and primary progressive MS
Rituximab
Another CD20-directed antibody (MabThera, Rituxan), a separate product with its own licensed uses
Edaravone
Radicava · a specialist neurology infusion, for ALS
All cns & neurology
The full category listing for procurement desks.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for ofatumumab.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Ofatumumab supply, the specific questions.
What is Kesimpta used for?
Kesimpta (ofatumumab) is used to treat relapsing forms of multiple sclerosis in adults. The US label includes clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The EU and UK wording is adults with relapsing forms of MS with active disease defined by clinical or imaging features. It is a subcutaneous injection, not an infusion, and treatment is started by a specialist. Always follow the labelling approved in your destination market.
What does the Kesimpta FDA label say about dose?
The FDA label gives 20 mg by subcutaneous injection at weeks 0, 1 and 2, then 20 mg once monthly from week 4. Each presentation delivers 20 mg/0.4 mL, in a single-dose Sensoready Pen or a pre-filled syringe. The label carries no boxed warning, contraindicates active hepatitis B infection, and requires hepatitis B screening before treatment. It also advises storage at 2 to 8 degrees Celsius in the original carton, protected from light, and not frozen.
What sets the price of Kesimpta, the 20 mg injection or the 20 mg pen for an importer?
We do not publish a price for Kesimpta. For an importer the landed price depends on whether you want the originator brand, the presentation (pen or syringe) and pack size, the order quantity, the destination's registration route, cold-chain freight and the Incoterms. M Care Exports quotes per destination, so a UAE hospital, a Nigerian distributor and a UK specialist pharmacy each receive a quote built for their own route. Send the destination, quantity and delivery terms and we come back with a written offer.
Is the Kesimpta 20 mg injection a pen or a syringe?
Both exist in the US, where the label lists a single-dose Sensoready Pen and a single-dose pre-filled syringe, each 20 mg/0.4 mL. The UK SmPC describes the pre-filled pen, in a pack of one or a multipack of three. The EMA record lists pre-filled syringes or pens. Presentations vary by market, so tell us which your regulator has approved and we quote that pack.
Is there a generic or biosimilar Kesimpta?
In the DailyMed Kesimpta record and the EMA and UK records we reviewed, the authorised multiple sclerosis product is Novartis's own Kesimpta, and we found no ofatumumab generic or biosimilar there. Those records cannot by themselves rule out a newer approval, and we have not verified the position in India. Because status can change, M Care checks the destination's current registers when it quotes. If a licensed alternative appears, we can source it alongside the originator.
How is Kesimpta different from Arzerra, and can M Care supply it to my country?
Arzerra is also ofatumumab but is a separate product, authorised in the EU for chronic lymphocytic leukaemia. The EMA record shows Novartis Europharm as holder and the authorisation withdrawn on 28 February 2019 at the holder's request, for commercial reasons. Kesimpta is the multiple sclerosis product. M Care supplies Kesimpta on an import basis against your licence and local registration, in validated cold-chain lanes. Tell us your country and we confirm the route.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-07.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.