Repatha (evolocumab) is a subcutaneous PCSK9 inhibitor given every two weeks or monthly to lower LDL cholesterol, supplied as 140 mg prefilled pens and syringes that stay refrigerated at 2°C to 8°C.
M Care Exports supplies Repatha (evolocumab) to hospital pharmacies, MoH tender desks and licensed importers in the GCC, Africa and the UK. Repatha is an Amgen biologic given by subcutaneous injection, so the buying questions are cold chain, device presentation and the destination's registration route. M Care is a merchant exporter: we source against your specification and quote per destination.
Evolocumab exporter and bulk supplier from India.
"I'm looking for Repatha for our lipid clinic" and "We need a partner for a refrigerated biologic that patients self-inject" are typical of the enquiries buyers send. M Care Exports quotes Repatha against the presentation you name: the US label lists a 140 mg/mL prefilled single-dose pen, SureClick autoinjector and prefilled syringe, while the EU SmPC adds a 420 mg cartridge with an automated mini-doser. Each quote also states pack size, quantity, the registration paperwork your regulator expects, the cold-chain lane and the Incoterms.
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.
PCSK9 inhibitor monoclonal antibody, sourced and documented for export.
Evolocumab is a human IgG2 monoclonal antibody against PCSK9, produced in Chinese hamster ovary cells. The US label lists Repatha to reduce the risk of major adverse cardiovascular events in adults at increased risk, and as an adjunct to diet and exercise to lower LDL-C in adults with hypercholesterolaemia and in adults and children aged 10 years and over with heterozygous or homozygous familial hypercholesterolaemia. The EU SmPC covers hypercholesterolaemia and mixed dyslipidaemia, homozygous familial hypercholesterolaemia from age 10, and established atherosclerotic cardiovascular disease. The usual dose is 140 mg every two weeks or 420 mg once monthly, given under the skin of the abdomen, thigh or upper arm. It must not be given intravenously or intramuscularly. The EU marketing authorisation dates from 17 July 2015 and the holder is Amgen Europe B.V.
Active ingredient
Evolocumab. PCSK9 inhibitor monoclonal antibody.
Forms and strengths
140 mg/mL solution for injection in prefilled single-dose pen or syringe; 420 mg/3.5 mL solution for injection in cartridge with automated mini-doser (EU).
Indications
Human IgG2 monoclonal antibody that binds PCSK9, indicated to lower LDL cholesterol and reduce cardiovascular risk.
Administration
Subcutaneous. Solution for injection in prefilled pen, autoinjector, syringe or cartridge.
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 and cardiology pharmacies running lipid clinics, MoH and hospital tender desks that list specialist biologics, licensed importers and distributors holding a cold-chain licence, and private hospital groups in the GCC, Africa and the UK. Because Repatha is prescribed for specific lipid indications and handled as a refrigerated biologic, it is bought by specialist pharmacy and import teams rather than general stores.
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 evolocumab.
Repatha is dosed as 140 mg every two weeks or 420 mg once monthly; the two schedules are described as clinically equivalent in the EU SmPC. A 420 mg dose from the 140 mg pens or syringes means three consecutive injections within 30 minutes, whereas the EU 420 mg cartridge is delivered in one go through the automated mini-doser. In homozygous familial hypercholesterolaemia both labels start at 420 mg monthly and allow a step up to every two weeks after 12 weeks, and patients on apheresis can start at 420 mg every two weeks, given after the session in the US label. Store the cartons at 2°C to 8°C, in the original carton, never frozen or shaken. Both labels allow up to 30 days (US, 20°C to 25°C) or one month (EU, up to 25°C) out of the fridge, after which the product is discarded; let it warm for at least 30 minutes before injecting. The needle cover of the US glass autoinjector and syringe presentations that carry the dry natural rubber warning contains a latex derivative, so check the carton for latex-sensitive patients. Serious hypersensitivity including angioedema is a contraindication on re-exposure.
The documentation pack a regulator actually asks for.
Repatha is a cold-chain biologic, so a quote covers the lane as well as the product: 2°C to 8°C transit, an excursion plan within the label's out-of-fridge allowance, and batch documents the receiving pharmacy can check. The EU SmPC gives a 3-year shelf life for the 140 mg syringe and pen and 2 years for the 420 mg cartridge. M Care Exports sources originator Repatha and aligns paperwork to the destination regulator (SFDA, the UAE's Emirates Drug Establishment, NAFDAC, PPB, SAHPRA or the UK MHRA route); registration status differs by market and we check it before we quote. The US label and the EU SmPC both identify Amgen as the originator. The labels we fetched list one brand, Repatha, and no other branded or subcutaneous version.
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 evolocumab.
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 evolocumab.
- 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.
Evolocumab supply, the specific questions.
What are the side effects of Repatha injection?
The US label contraindicates Repatha in anyone with a history of serious hypersensitivity to evolocumab or its excipients, and angioedema has been reported. In its 52-week trial table, nasopharyngitis, upper respiratory tract infection, influenza, back pain and injection site reactions were the adverse reactions seen more often than on placebo. The EU SmPC names nasopharyngitis among the most commonly reported. Prescribers and pharmacovigilance teams should use the full destination-market leaflet; M Care Exports supplies product, not clinical advice.
What is the Repatha dosage, and how do the devices differ?
For hypercholesterolaemia and cardiovascular risk reduction, both labels give 140 mg every two weeks or 420 mg once monthly by subcutaneous injection. In homozygous familial hypercholesterolaemia the start is 420 mg monthly, with a possible step up to every two weeks after 12 weeks. The 140 mg pen, SureClick autoinjector and syringe each deliver one 140 mg dose, so 420 mg takes three injections within 30 minutes. The EU 420 mg cartridge with automated mini-doser delivers it as one dose.
Can you supply Repatha to the UAE, and what do you need from us?
Yes. If you write "I'm looking for Repatha in the UAE", M Care Exports quotes it against your presentation, pack size and quantity. Registration status for a UAE importer must be confirmed with the Emirates Drug Establishment (EDE) before shipment, so send the import permit details, the receiving cold-chain facility and the delivery point and we will confirm the route in the quote.
What decides the price of Repatha 140 mg for an importer?
The landed price depends on originator supply, the presentation and pack size, the quantity, the destination's registration and import route, the cold-chain lane and the Incoterms. Repatha is a branded biologic, so there is no single list price that fits every market. M Care Exports quotes per destination after we know these details, and we do not publish prices on this page.
Is there a generic or biosimilar of Repatha, and how does it compare with Leqvio?
The US label and the EU product page we fetched name Repatha as the only product under this brand, and we have not confirmed an approved evolocumab generic or biosimilar in the US, EU or India from a regulator source. We recheck this before each quote. Leqvio is a different product, and choosing between the two is a prescriber and formulary decision. We can quote either as the tender specifies.
Does Repatha SureClick need cold-chain handling during shipment?
Yes. Both labels require storage at 2°C to 8°C in the original carton, away from light, without freezing. The US label allows 30 days at 20°C to 25°C and the EU SmPC allows one month at up to 25°C, after which the product is discarded. We plan lanes so the allowance is a safety margin, not part of the journey, and the receiving pharmacy should check temperature records on arrival.
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.