Leqvio (inclisiran) is Novartis's small interfering RNA directed to PCSK9 mRNA, a 284 mg prefilled syringe given by a healthcare professional at the start, at 3 months and then every 6 months, and labelled for storage without refrigeration.
M Care Exports supplies Leqvio (inclisiran), the Novartis originator, to hospital pharmacies, importers and tender desks in the GCC, Africa and the UK. If you are looking for Leqvio injection, send the destination, the quantity and the registration route you need, and we confirm what your regulator has registered before we quote.
Inclisiran exporter and bulk supplier from India.
"We need a partner for Leqvio" is a typical cardiology, lipid-clinic or tender enquiry. M Care is a merchant-exporter: we source the originator against your specification and quote per destination, confirming what your destination has registered before we offer. Leqvio has one strength, 284 mg in a single-dose prefilled syringe (the UK SmPC lists versions with and without a needle guard), so the quote turns on quantity, remaining shelf life at arrival, the registration route and Incoterms. The UK SmPC requires no special storage conditions beyond not freezing, and the US label sets controlled room temperature, so under those labels there is no refrigerated lane to price. For the antibody alternative that lipid units compare, see our evolocumab (Repatha) page.
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.
Small interfering RNA (siRNA) directed to PCSK9 mRNA, sourced and documented for export.
Inclisiran is a small interfering RNA (siRNA) directed to PCSK9 mRNA, given by subcutaneous injection. Each single-dose prefilled syringe holds 284 mg of inclisiran in 1.5 mL (189 mg/mL). The US label states that the 284 mg of inclisiran is present as 300 mg of inclisiran sodium salt, and the UK SmPC notes that some studies refer to the same dose as 300 mg inclisiran sodium salt. The recommended dose is 284 mg at the first visit, again at 3 months, then every 6 months. The US label lists LDL-C lowering as an adjunct to diet and exercise in adults with hypercholesterolaemia, in adults and children aged 12 and over with heterozygous familial hypercholesterolaemia, and in children aged 12 and over with homozygous familial hypercholesterolaemia. The EMA lists adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet, with a statin or other lipid-lowering therapy when LDL-C goals are not met, or alone when a statin is not tolerated or is contraindicated. The UK SmPC states that safety and efficacy under 18 have not been established.
Active ingredient
Inclisiran sodium. Small interfering RNA (siRNA) directed to PCSK9 mRNA.
Forms and strengths
284 mg/1.5 mL (189 mg/mL) single-dose prefilled syringe.
Indications
Inclisiran (Leqvio), a small interfering RNA directed to PCSK9 mRNA for LDL-C lowering, given by a healthcare professional at the start, at 3 months and then every 6 months. Supplied as the Novartis originator to regulated and semi-regulated markets.
Administration
Subcutaneous. Solution for injection in a single-dose prefilled 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 pharmacists and cardiology or lipid-clinic formulary leads, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Leqvio injection for a lipid clinic" or "We need a partner for Leqvio 284 mg for a tender". Each destination has its own registration route, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria and the MHRA in the UK, and we align the offer with it before quoting. Because Leqvio is given by a healthcare professional, hospital and clinic pharmacies are the main buyers rather than retail channels.
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 inclisiran.
Leqvio is one fixed dose, so the ward questions are about timing and administration. The label schedule is 284 mg at the first visit, again at 3 months, then every 6 months. If a dose is missed by under 3 months, give it and keep the original schedule; if by more than 3 months, restart the schedule. Both the US label and the UK SmPC say it is for administration by a healthcare professional, into the abdomen, upper arm or thigh, avoiding areas of active skin disease or injury. Inspect the syringe before use and do not use it if particulate matter or discolouration is seen. The US label warns of hypersensitivity reactions including anaphylaxis and angioedema, and lists injection site reaction, arthralgia and bronchitis as common adverse reactions in clinical trials. The UK SmPC advises against haemodialysis for at least 72 hours after dosing. Per the UK SmPC, a patient moving from a PCSK9 monoclonal antibody can start inclisiran immediately after the last antibody dose, and starting within 2 weeks of it is recommended to maintain LDL-C lowering.
The documentation pack a regulator actually asks for.
Storage differs by label, so build the lane to the destination's registered label. The US label says store at controlled room temperature, 20 to 25 °C, with allowable excursions between 15 and 30 °C. The UK SmPC says no special storage conditions are required, do not freeze, and gives a shelf life of 3 years. The EMA lists Novartis Europharm Limited as the EU marketing authorisation holder, with authorisation issued on 9 December 2020. The UK SmPC names Novartis Pharmaceuticals UK Limited as the UK holder, and the US label names Novartis Pharmaceuticals Corporation. Packs are a single prefilled syringe, with or without a needle guard in the UK, and the UK SmPC notes not all pack sizes may be marketed. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator requires it. We state each source's quality status per line before quoting, and make no claim for M Care itself beyond merchant-exporter documentation.
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 inclisiran.
Rosuvastatin
Hydrophilic HMG-CoA reductase inhibitor (statin) · NHS Cat M · NICE NG181 · 5/10/20/40mg
Ezetimibe
Cholesterol absorption inhibitor · hypercholesterolaemia
Atorvastatin
Statin · dyslipidaemia · NHS Cat M
Alirocumab (Praluent)
PCSK9 inhibitor antibody · LDL-C lowering
All cardiovascular
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 inclisiran.
- 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.
Inclisiran supply, the specific questions.
What does Leqvio cost, and what sets the landed price for an importer?
We do not publish prices. The landed cost of Leqvio depends on the quantity, the remaining shelf life you require at arrival, the registration route in your destination, the freight lane and Incoterms. Because the UK SmPC requires no special storage and the US label sets controlled room temperature, refrigerated freight is not the cost driver it is for most biologicals. M Care Exports quotes per destination once you send the country, the quantity and the registration route.
What is Leqvio 284 mg, and how does it relate to inclisiran sodium?
Leqvio is a single-dose prefilled syringe containing 284 mg of inclisiran in 1.5 mL, which is 189 mg/mL. The US label states that the 284 mg of inclisiran is present as 300 mg of inclisiran sodium salt. The UK SmPC says the same dose is sometimes written as 300 mg inclisiran sodium salt in studies. They are one product and one dose, not two strengths.
How is Leqvio dosed and administered?
The dose is 284 mg by subcutaneous injection at the first visit, again at 3 months, then every 6 months. The US label and UK SmPC both say it is for administration by a healthcare professional, into the abdomen, upper arm or thigh. If a dose is missed by less than 3 months, it is given and the original schedule continues. After more than 3 months, the schedule restarts from the initial dose.
Leqvio vs Repatha: how do they differ on the label?
Leqvio is an siRNA directed to PCSK9 mRNA, given by a healthcare professional at the first visit, 3 months, then every 6 months. Repatha (evolocumab) is a monoclonal antibody that attaches to the PCSK9 protein; for most of its labelled groups the EMA page gives 140 mg every two weeks or 420 mg once a month, and says patients can self-administer once properly trained. They are different products with separate registrations and dosing. We compare on label facts only and do not recommend one over the other. See our evolocumab page.
Is there a generic of Leqvio?
In the US, Drugs@FDA lists a single inclisiran application, Novartis's NDA 214012 for Leqvio. In the EU and the UK, the regulator pages we read name only the Novartis holders for Leqvio, and we make no further claim about generics there. The position can differ by destination, so if your regulator has registered another inclisiran product, send the registration and we confirm what we can supply. M Care quotes the originator and confirms any other version per enquiry.
What are the labelled uses and common side effects of Leqvio?
The EMA lists primary hypercholesterolaemia or mixed dyslipidaemia in adults, as an adjunct to diet. The US label covers adults with hypercholesterolaemia, adults and children aged 12 and over with heterozygous familial hypercholesterolaemia, and children aged 12 and over with homozygous familial hypercholesterolaemia. The US label lists injection site reaction, arthralgia and bronchitis as common adverse reactions in clinical trials, and warns of hypersensitivity including anaphylaxis. It is contraindicated after a prior serious hypersensitivity reaction to inclisiran or any excipient. Full prescribing information governs clinical use.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-08.
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.
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