Vasotec (enalapril), sold in the UK as Innovace and across Europe as Renitec, is licensed for hypertension, symptomatic heart failure and asymptomatic left ventricular dysfunction, and generic enalapril maleate tablets are now the dominant supply route on most tenders.
Vasotec (enalapril maleate), originated by Merck and marketed in the UK as Innovace and across parts of Europe as Renitec, is an oral ACE inhibitor dosed once or twice daily for hypertension and heart failure. M Care Exports is a merchant exporter: we source generic enalapril maleate tablets and, where a tender specifies it, the Innovace brand, through licensed Indian WHO-GMP manufacturing channels and dispatch on quote, not from our own manufacturing.
Enalapril exporter and bulk supplier from India.
For hospital pharmacy, wholesaler and MoH tender orders, M Care quotes enalapril maleate tablets against buyer specification: strength mix (2.5 mg, 5 mg, 10 mg, 20 mg), pack size and destination-market regulatory documentation, drawn from multiple WHO-GMP partner lines on the M Care roster. Because enalapril is contra-indicated in the second and third trimesters of pregnancy and dosing differs sharply between the hypertension and heart-failure indications, we confirm the buyer's intended formulary use before dispatch, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.
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.
ACE (angiotensin-converting enzyme) inhibitor; prodrug hydrolysed to enalaprilat, sourced and documented for export.
Enalapril is a prodrug ACE (angiotensin-converting enzyme) inhibitor: it is hydrolysed in the liver to enalaprilat, the active moiety, which blocks conversion of angiotensin I to angiotensin II, reducing peripheral vascular resistance and aldosterone secretion. It is dosed orally, once daily for most hypertension patients and often twice daily in heart failure, and needs no reconstitution. The FDA and UK-licensed indications cover hypertension, alone or with a thiazide diuretic; symptomatic heart failure, usually alongside a diuretic and digitalis; and asymptomatic left ventricular dysfunction, where enalapril reduces the rate of overt heart failure and hospitalisation in stable patients with an ejection fraction of 35% or below. Enalapril is a chemical agent on the WHO Model List of Essential Medicines, listed under both antihypertensive medicines and medicines used in heart failure, first added in 2003. Destination-country labelling should be checked against this before a tender quote is finalised. Vasotec/Innovace is supplied as 2.5 mg, 5 mg, 10 mg and 20 mg tablets.
Active ingredient
enalapril maleate. ACE (angiotensin-converting enzyme) inhibitor; prodrug hydrolysed to enalaprilat.
Forms and strengths
2.5 mg tablet; 5 mg tablet; 10 mg tablet; 20 mg tablet.
Indications
Oral ACE-inhibitor prodrug indicated for hypertension, symptomatic heart failure and asymptomatic left ventricular dysfunction, dosed once daily for hypertension and often twice daily for heart failure, and carrying a boxed warning against use in the second and third trimesters of pregnancy.
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 enalapril are mainly hospital cardiology and general-medicine pharmacies managing hypertension and heart-failure formularies, national and regional MoH tender desks running cardiovascular procurement lists, licensed pharmaceutical wholesalers and importers stocking a chronic-disease range, and NGO or foundation procurement programmes supporting non-communicable disease treatment access in markets where local registration is in place. Because enalapril sits on the WHO Essential Medicines List, it is a recurring line on national essential-medicines tenders across our GCC and African markets rather than a specialist or occasional order.
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 enalapril.
Enalapril dosing splits by indication, which drives pack-mix planning at the tender stage. For hypertension without a diuretic, start at 5 mg once daily, titrating to a usual range of 10-40 mg daily; when a patient is already on a high-dose diuretic, start at 2.5 mg or lower under supervision, since volume depletion from prior diuretic use raises the risk of first-dose hypotension, and stopping the diuretic 2-3 days beforehand where clinically possible reduces that risk further. Heart-failure dosing starts lower still, at 2.5 mg, and is typically titrated twice daily as tolerated rather than as a single daily dose. Renal impairment needs a dose cut: creatinine clearance at or below 30 mL/min calls for a 2.5 mg starting dose, and dialysis patients are dosed only on dialysis days. Enalapril carries a boxed warning: agents acting on the renin-angiotensin system cause fetal injury and death when used in the second and third trimesters, so pregnancy status should be confirmed at dispensing and enalapril discontinued as soon as pregnancy is detected. Enalapril tablets need no cold chain and store at controlled room temperature, protected from moisture, in the original pack.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, enalapril travels on standard ambient-temperature logistics rather than the validated cold-chain lanes M Care runs for biologics and vaccines. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product. On the brand-versus-generic question, Vasotec and its UK equivalent Innovace remain the originator products developed by Merck; the molecule's patent expired in 2000, and multiple FDA-approved generic enalapril maleate manufacturers have since entered the market alongside branded supply, which is now distributed in the US under Bausch Health rather than Merck. Enalapril sits on the WHO Model List of Essential Medicines under both antihypertensive medicines and medicines used in heart failure, which keeps it on national essential-medicines and NCD tenders across the GCC and African markets M Care serves, distinct from newer patent-protected cardiovascular agents that compete for the same formulary budget. It is not a controlled substance in any market we currently review, so the documentation load sits closer to a conventional generic tablet than to a scheduled drug.
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 enalapril.
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 enalapril.
- 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.
Enalapril supply, the specific questions.
Does a generic version of Vasotec/Innovace exist?
Yes. Enalapril's patent expired in 2000 and FDA-approved generic enalapril maleate tablets are registered and marketed alongside the originator brand, which in the US is now distributed under Bausch Health rather than Merck. Registration status for generic enalapril varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
What is enalapril licensed to treat?
Enalapril is licensed for hypertension, alone or combined with a thiazide diuretic; symptomatic heart failure, usually alongside a diuretic and digitalis; and asymptomatic left ventricular dysfunction, where it reduces the rate of overt heart failure in stable patients with an ejection fraction of 35% or below. Check destination-country labelling for the exact approved indication wording your market requires.
What strengths of enalapril tablets does M Care supply?
2.5 mg, 5 mg, 10 mg and 20 mg tablets, matching the Vasotec/Innovace strengths. Tell us your dosing protocol, whether the order is for hypertension or heart-failure use, and we quote the strength mix accordingly.
Is enalapril safe to use during pregnancy?
No. Enalapril carries a boxed warning: drugs acting on the renin-angiotensin system cause fetal injury and death when used in the second and third trimesters of pregnancy. Prescribing information requires discontinuation as soon as pregnancy is detected, so pregnancy status should be confirmed at dispensing.
Does enalapril need cold-chain shipping?
No. Enalapril tablets are stored at controlled room temperature, protected from moisture, and move on standard ambient logistics rather than the validated cold-chain lanes we use for biologics.
Is enalapril on the WHO Essential Medicines List?
Yes. Enalapril has been on the WHO Model List of Essential Medicines since 2003, listed under both antihypertensive medicines and medicines used in heart failure, which keeps it on national essential-medicines tenders across our GCC and African markets.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-13.
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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