Praluent (alirocumab) is a PCSK9 antibody injected under the skin every 2 or 4 weeks to lower LDL cholesterol, supplied as refrigerated 75 mg and 150 mg pre-filled pens, with a 300 mg pen in the EU and UK.
M Care Exports supplies Praluent (alirocumab), a PCSK9 monoclonal antibody for lowering LDL cholesterol, to hospital pharmacies, lipid clinics, importers and tender desks in the GCC, Africa and the UK. If you are looking for Praluent 75 mg, 150 mg or 300 mg pens, send the destination, the strength and the quantity, and we quote per destination.
Alirocumab exporter and bulk supplier from India.
"We need a partner for Praluent" is a typical enquiry from a cardiology pharmacy or an importer holding a cold-chain licence. M Care is a merchant-exporter: we quote against your specification and confirm which presentation your destination registers. The strengths are not identical everywhere. The US label lists 75 mg/mL and 150 mg/mL single-dose pens only, and gives the 300 mg dose as two 150 mg injections. The EU SmPC and the UK SmPC list a 300 mg/2 mL pen as well, and the EU SmPC adds pre-filled syringes of 75 mg and 150 mg. Praluent is stored at 2 to 8 °C, so the quote also covers the cold chain. The price turns on strength, pack, quantity, the registration route in the destination, cold-chain freight and 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.
Praluent is a prescription proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor. Its active substance, alirocumab, is a human monoclonal antibody that binds PCSK9, which stops PCSK9 promoting breakdown of the LDL receptor in the liver, so more receptors are available to clear LDL cholesterol. The US label (revised October 2025) lists three uses: reducing the risk of major adverse cardiovascular events in adults at increased risk, lowering LDL-C in adults with hypercholesterolaemia, and lowering LDL-C in adults and children aged 8 years and older with heterozygous familial hypercholesterolaemia, plus adults with homozygous familial hypercholesterolaemia. The EU SmPC covers primary hypercholesterolaemia and mixed dyslipidaemia in adults and in children aged 8 and over with heterozygous familial hypercholesterolaemia, and established atherosclerotic cardiovascular disease in adults. The UK SmPC on the emc (revised 4 November 2025) lists the same indications. The US label names Regeneron Pharmaceuticals as manufacturer. The EU marketing authorisation holder is Sanofi Winthrop Industrie, authorised on 23 September 2015, and the UK marketing authorisation holder is Aventis Pharma Limited, trading as Sanofi.
Active ingredient
Alirocumab. PCSK9 inhibitor monoclonal antibody.
Forms and strengths
75 mg/mL single-dose pre-filled pen; 150 mg/mL single-dose pre-filled pen; 300 mg/2 mL single-dose pre-filled pen (EU and UK).
Indications
Alirocumab is a human monoclonal antibody that binds proprotein convertase subtilisin kexin type 9 (PCSK9), increasing the number of LDL receptors available to clear LDL cholesterol. It is given subcutaneously every 2 or 4 weeks.
Administration
Subcutaneous. Solution for injection in pre-filled pen (pre-filled syringe in the EU).
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 pharmacists running lipid clinics, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Praluent 150 mg pens for a hospital pharmacy" or "We need a partner for alirocumab for a tender". Each destination has its own route to registration or import, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria and the MHRA in the UK, and the route depends on the destination regulator. We confirm it per enquiry before quoting. Praluent is an originator biologic, and we also discuss other PCSK9 lines such as evolocumab and inclisiran if your tender covers the class.
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 alirocumab.
Start with the schedule, because it differs by market. The US label starts adults on 75 mg every 2 weeks or 300 mg every 4 weeks, adjusts to 150 mg every 2 weeks if LDL-C response is inadequate, and sets 150 mg every 2 weeks for adults with heterozygous familial hypercholesterolaemia on LDL apheresis and for adults with homozygous familial hypercholesterolaemia. For the every-4-weeks schedule it advises measuring LDL-C just before the next dose. The EU and UK texts allow all three regimens at initiation, with 150 mg every 2 weeks as the maximum dose. The 300 mg dose is one 300 mg pen (EU and UK) or two consecutive 150 mg injections at different sites. Missed doses follow different rules: the US label allows a dose within 7 days and resumes the original schedule, and after 7 days a 2-weekly patient waits for the next dose while a 4-weekly patient injects and starts a new schedule from that day. The EU and UK texts say to give a missed dose as soon as possible and then resume the original schedule. Allow the pen to warm for 30 to 40 minutes after refrigeration and do not put it back in the refrigerator. Store at 2 to 8 °C in the carton, away from light, and do not freeze. Out of the fridge, the US label allows up to 25 °C for 30 days, and the EU and UK SmPCs allow below 25 °C for a single period of up to 30 days. Plan stock rotation around that window.
The documentation pack a regulator actually asks for.
The EU SmPC gives a shelf life of 3 years for the 75 mg pen and syringe and 2 years for the 150 mg pen and syringe and the 300 mg pen. EU pack sizes are 1, 2, 3 or 6 pens for 75 mg and 150 mg (including a multipack of 2 packs of 3), 1 or 3 pens for 300 mg, and 1, 2 or 6 syringes, and the SmPC notes that not all presentations may be marketed. The US label states Praluent is sterile, preservative-free and supplied in a siliconised 1 mL glass syringe within the pen. It contraindicates use after a serious hypersensitivity reaction to alirocumab or any excipient, and the EU and UK texts note allergic reactions including angioedema. The EU SmPC also asks that the name and batch number of each administered dose be recorded for traceability. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator requires it. We state the source and quality status of each line before quoting, and make no claim for M Care itself beyond merchant-exporter documentation. Because Praluent is a refrigerated biologic, we agree the temperature-controlled lane and the recorder with you before dispatch.
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 alirocumab.
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 alirocumab.
- 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.
Alirocumab supply, the specific questions.
What decides the landed price of Praluent for an importer?
We do not publish prices. The landed cost depends on the strength (75 mg, 150 mg or 300 mg), the pack, the quantity, the registration route in your destination, cold-chain freight at 2 to 8 °C and Incoterms. Praluent is an originator product, so the supply source also matters. M Care Exports quotes per destination once we have the strength, quantity and delivery point. The same applies to alirocumab cost enquiries.
What is the difference between Praluent 75 mg, 150 mg and 300 mg?
The numbers are the dose per pen. The 75 mg and 150 mg pens each hold the dose in 1 mL, and the EU and UK 300 mg pen holds 300 mg in 2 mL. The EU and UK SmPCs give the regimens as 75 mg or 150 mg every 2 weeks, or 300 mg every 4 weeks, with 150 mg every 2 weeks as the maximum. The US label lists only 75 mg/mL and 150 mg/mL pens and gives the 300 mg dose as two 150 mg injections. Confirm which presentation your destination registers before ordering.
Praluent vs Repatha: how do they compare on the labels?
Both are human monoclonal antibodies against PCSK9 and are given subcutaneously. On the US labels, Praluent is dosed at 75 mg every 2 weeks or 300 mg every 4 weeks, adjusted to 150 mg every 2 weeks, while Repatha is dosed at 140 mg every 2 weeks or 420 mg once monthly in adults with hypercholesterolaemia and in heterozygous familial hypercholesterolaemia. Praluent's paediatric indication starts at age 8 for heterozygous familial hypercholesterolaemia, and Repatha's starts at age 10 for heterozygous or homozygous disease. Both US labels allow storage at room temperature, up to 25 °C, for 30 days. This is a label comparison only. The choice belongs to the prescriber. We supply evolocumab as well.
What is the generic name of Praluent, and is there a generic or biosimilar?
The non-proprietary name is alirocumab. Praluent is the brand name. Alirocumab is a monoclonal antibody, so any follow-on version would be a biosimilar rather than a generic. The EMA page for Praluent, last updated 9 January 2026, mentions no biosimilar. We have not confirmed a biosimilar listing for the US, EU or UK, so we quote the originator product. Check the position for your destination at enquiry.
Is Praluent a pen or a syringe, and does it need refrigeration?
Praluent is a single-dose pre-filled pen in the US, EU and UK. The EU SmPC also lists pre-filled syringes of 75 mg and 150 mg. It must be refrigerated at 2 to 8 °C in the carton and not frozen. The US label allows up to 25 °C for 30 days once out of the fridge, and the EU and UK SmPCs allow below 25 °C for a single period of up to 30 days. After that, discard it. Quotes include the cold-chain lane.
What are the common Praluent side effects and warnings buyers should know?
The EU and UK texts list injection site reactions, upper respiratory signs and pruritus as common. Rare allergic reactions such as hypersensitivity, urticaria and hypersensitivity vasculitis are reported, and angioedema has been reported. The US label contraindicates Praluent after a serious hypersensitivity reaction to alirocumab or any excipient. If a serious allergic reaction occurs, treatment should stop. Prescribers should read the full label for the destination. Pharmacists should check which label applies to their market.
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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