Zetia (ezetimibe), formerly marketed in the UK as Ezetrol (now discontinued there in favour of generics), is a once-daily oral cholesterol absorption inhibitor added to a statin, or used alone when a statin cannot be tolerated, and FDA and MHRA-approved generic ezetimibe tablets now cover most of this demand.
Zetia (ezetimibe) blocks intestinal absorption of dietary and biliary cholesterol at the NPC1L1 transporter, lowering LDL-C on top of, or instead of, a statin; in the UK it was sold as Ezetrol, a brand now discontinued in favour of generic ezetimibe. M Care Exports is a merchant exporter: we source the originator brand where a buyer specifies it, and FDA and MHRA-approved generic ezetimibe tablets, through licensed Indian distribution channels, and dispatch on quote, not from our own manufacturing.
Ezetimibe exporter and bulk supplier from India.
For hospital pharmacy, wholesaler and MoH tender-desk orders, M Care quotes ezetimibe 10 mg tablets against buyer specification: brand (Zetia, or Ezetrol where still registered) or generic, pack format and destination-market dossier requirements, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Ezetimibe is a single-strength, room-temperature oral product with no cold-chain step, which simplifies freight planning; the buyer-facing question is almost always brand-versus-generic and pack count, not storage. We confirm whether the tender wants monotherapy or an ezetimibe/statin fixed-dose combination before quoting, since the two sit on different SKUs.
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.
Cholesterol absorption inhibitor (NPC1L1 inhibitor), sourced and documented for export.
Ezetimibe is a cholesterol absorption inhibitor: it binds NPC1L1 on the brush border of the small intestine, blocking uptake of dietary and biliary cholesterol and increasing LDL receptor expression in the liver, without inhibiting cholesterol synthesis the way a statin does. It carries no boxed warning. The current US FDA label (Zetia) sets the flagship use as adjunctive therapy to diet, alone or with a statin, for primary hyperlipidaemia, and, with a statin, for homozygous familial hypercholesterolaemia and homozygous sitosterolaemia. The UK Ezetrol and generic ezetimibe SmPCs add a secondary indication: reducing cardiovascular events in patients with coronary heart disease and a history of acute coronary syndrome, when added to ongoing statin therapy. It is dosed at a single 10 mg tablet once daily, with or without food; no renal-impairment adjustment is needed, and it is not recommended in moderate-to-severe hepatic impairment. The Ezetrol brand has been discontinued in the UK in favour of MHRA-approved generic ezetimibe tablets from multiple manufacturers.
Active ingredient
Ezetimibe. Cholesterol absorption inhibitor (NPC1L1 inhibitor).
Forms and strengths
10 mg tablet.
Indications
Ezetimibe, an NPC1L1 cholesterol absorption inhibitor sold as Zetia (US) and formerly as Ezetrol (UK), is indicated as adjunctive therapy to diet, alone or with a statin, for primary hyperlipidaemia. Supplied from Indian WHO-GMP facilities as brand or generic tablets to regulated and semi-regulated export markets.
Administration
Oral. Tablet.
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 for ezetimibe are mainly hospital cardiology and lipid-clinic pharmacies, primary-care and NHS trust formularies, MoH tender desks managing chronic-disease medicine lists, and licensed importers stocking a cardiovascular range for retail and hospital channels. India is our origin. We do not sell into the Indian market. Ezetimibe is exported only.
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 ezetimibe.
Ezetimibe is a maintenance oral product, not an acute-care line, so procurement planning is straightforward compared with an injectable: one strength (10 mg), no reconstitution, no light-sensitivity handling, no cold chain. Storage is 20-25°C, protect from moisture, standard room-temperature warehousing. The dosing nuance that matters for a tender desk is combination logic, not the dose itself: ezetimibe is added to an existing statin when that statin alone has not brought a patient to target, or given alone when a statin is contraindicated or not tolerated; renal impairment needs no dose change, but moderate-to-severe hepatic impairment is a reason to avoid it. Buyers should also expect brand fragmentation: the Ezetrol brand has been discontinued in the UK in favour of generic ezetimibe, and a 2024 UK parliamentary answer confirmed supply issues affecting several ezetimibe manufacturers, which is why we quote against more than one WHO-GMP line rather than a single source. There is no controlled-drug status and no paediatric dosing claim beyond specialist-only use, which we do not extend past the label.
The documentation pack a regulator actually asks for.
M Care sources ezetimibe tablets from WHO-GMP manufacturer lines on our Indian roster and aligns CTD/eCTD or country-specific dossier paperwork to each destination regulator, whether that is an MHRA import route, a GCC MoH registration, or an African NAFDAC/PPB/SAHPRA submission. We are a merchant exporter, not a manufacturer: we do not hold our own WHO-GMP or WHO-PQ certification, and any manufacturer credential we cite is the partner site's, verified against the current label before it is quoted.
Buyers new to sourcing from India usually read the licensed import route explainer first, then the product page.
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 ezetimibe.
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 ezetimibe.
- 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.
Ezetimibe supply, the specific questions.
I'm looking for ezetimibe tablets, brand or generic, what can M Care supply?
We can quote either. M Care sources the originator brand (Zetia in the US, Ezetrol where still registered in a given market) when a buyer specifies it, and FDA and MHRA-approved generic ezetimibe 10 mg tablets from licensed Indian WHO-GMP lines when a generic tender or formulary line is what's wanted. Tell us which your tender or formulary requires and we quote against buyer specification, not our own default.
Is Ezetrol still available, or is it generic-only now?
The Ezetrol brand has been discontinued in the UK, per its own current MHRA-registered product listing, and generic ezetimibe 10 mg tablets from multiple manufacturers have taken its place on UK formularies. In markets where an Ezetrol-branded registration is still active we can still source it; where it has lapsed, we quote MHRA or FDA-approved generic ezetimibe instead.
Do you supply ezetimibe/statin combination tablets, or only the plain molecule?
This page covers plain ezetimibe 10 mg tablets. Fixed-dose ezetimibe/statin combinations (ezetimibe with simvastatin, atorvastatin or rosuvastatin) sit on separate SKUs with their own strengths and dossiers; if your tender wants a combination product, tell us the statin and strength and we'll quote that line separately rather than substituting it here.
We need a partner for ongoing ezetimibe supply given the 2024 UK shortage reports, how does M Care manage that?
A UK parliamentary written answer in April 2024 confirmed supply issues affecting several ezetimibe manufacturers, which the Department of Health and Social Care was managing with alternative sources. We quote ezetimibe against more than one licensed WHO-GMP manufacturer line on our roster rather than a single source, so a tender or formulary order isn't dependent on one factory's output.
Does ezetimibe need cold-chain shipping or special handling?
No. Ezetimibe tablets are stored at 20-25°C and protected from moisture, per the current US and UK product labelling, the same as most oral cardiovascular tablets. There's no cold chain, no light-sensitivity handling and no reconstitution step, which keeps freight and warehousing straightforward for hospital pharmacy and wholesaler orders.
Is ezetimibe a controlled drug, and does it need a special import licence?
No, ezetimibe carries no controlled-drug status in the US, UK or EU. Import documentation is the standard route for a prescription-only oral cardiovascular medicine: MHRA import notification or named-patient route in the UK, or the relevant MoH registration and CTD dossier in GCC and African markets, which M Care's regulatory desk prepares against each destination's requirements.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-25.
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.