Nicorandil never received US FDA approval, and everywhere it is licensed (the UK, EU, Japan, Australia and New Zealand) regulators restrict it to second-line angina therapy because of a distinctive ulceration risk unmatched by other anti-anginals.
Nicorandil has no US FDA approval, and in every market where it is licensed (the UK, EU, Japan, Australia and New Zealand) it sits behind first-line anti-anginal therapy on the formulary. The reason is a well-documented, dose-related ulceration risk affecting the mouth, gut, skin and mucosa. M Care sources nicorandil oral tablets in 5mg, 10mg and 20mg strengths from WHO-GMP certified Indian manufacturers, with export documentation prepared for licensed importers and tender desks in the regions that still prescribe it.
Nicorandil exporter and bulk supplier from India.
Export consignments are prepared as finished oral tablets (5mg, 10mg, 20mg) with batch-specific certificates of analysis, certificates of pharmaceutical product, and stability data matching the sourcing manufacturer's storage conditions, since nicorandil tablets are sensitive to heat and humidity and are typically packed in blister strips with foil backing rather than bulk bottles. Documentation is assembled to match the importing country's licensing category for a second-line cardiovascular medicine, including the manufacturer's WHO-GMP certificate, free sale certificate and any dossier pages a tender desk or import licence holder requests. M Care's own export paperwork carries our ISO 9001:2015 certification and CDSCO export licence; we do not generate or estimate lead times, minimum order quantities or landed pricing outside a formal quotation issued against a specific enquiry and destination.
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.
Potassium channel activator / nicotinamide nitrate vasodilator (anti-anginal), sourced and documented for export.
Nicorandil has never been approved by the US FDA. It is licensed in the United Kingdom, the wider European Union, Japan, Australia, New Zealand and a scatter of other markets, and in every one of those jurisdictions the label restricts it to second-line use for stable angina, reserved for patients whose symptoms are inadequately controlled by, or who cannot tolerate, first-line agents such as beta-blockers or calcium channel blockers. The restriction follows directly from nicorandil's defining safety signal: dose-related ulceration of the mouth, gastrointestinal tract, skin, perianal and genital mucosa, and occasionally the eye, which can progress to perforation, fistula or haemorrhage and typically resolves only when the drug is withdrawn. M Care supplies nicorandil as plain oral tablets in 5mg, 10mg and 20mg strengths, sourced from WHO-GMP certified Indian manufacturers, for buyers in markets where the molecule holds an active marketing authorisation.
Active ingredient
Nicorandil. Potassium channel activator / nicotinamide nitrate vasodilator (anti-anginal).
Forms and strengths
5 mg; 10 mg; 20 mg.
Indications
Nicorandil is an anti-anginal agent that combines ATP-sensitive potassium channel activation with nitrate-ester mediated vasodilation. It is used as second-line prophylaxis and treatment of stable angina pectoris in patients inadequately controlled by, or intolerant of, first-line anti-anginal therapies. M Care supplies nicorandil exclusively as oral tablets in 5mg, 10mg and 20mg strengths, sourced from WHO-GMP certified Indian manufacturers, for export to markets where the molecule holds an active marketing authorisation.
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.
Nicorandil moves through hospital pharmacy and cardiology tender desks in the UK, the wider EU, Australia, New Zealand and Gulf/GCC importers who hold marketing authorisations tied to those regulatory frameworks, plus licensed distributors in Southeast Asia and CIS markets where the molecule is registered. Because it is second-line by label in every jurisdiction that licenses it, ordering volumes track formulary substitution after first-line failure rather than first-prescription volume, so buyers tend to be established cardiology-focused wholesalers and hospital group procurement teams rather than new-to-market retail pharmacy chains. We do not offer nicorandil into markets without an active local marketing authorisation for it, and we do not supply the Indian domestic market, which is outside our export mandate.
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 nicorandil.
Nicorandil combines two mechanisms in one molecule: an ATP-sensitive potassium channel opener and a nitrate ester, giving both arterial and venous dilation. A pharmacist reviewing an order checks for concomitant phosphodiesterase-5 inhibitors and soluble guanylate cyclase stimulators, which are contraindicated with nicorandil due to severe hypotension, and for aspirin, other NSAIDs or corticosteroids, which raise the risk of gastrointestinal ulceration, perforation and haemorrhage. Diverticular disease is a specific caution, since fistula and bowel perforation have been reported in that population. The defining monitoring point is ulceration: any new ulcer of the mouth, gastrointestinal tract, skin, perianal or genital mucosa, or eye, at any stage of treatment, even years after initiation, should prompt permanent discontinuation, because these ulcers are usually refractory to standard treatment and resolve mainly on withdrawal. Contraindications also include cardiogenic shock, severe hypotension, hypovolaemia, left ventricular failure with low filling pressure, and acute pulmonary oedema. Headache is the most frequently reported adverse effect; product labelling lists 10mg twice daily as the usual starting dose, with a lower 5mg twice daily start reserved for patients particularly prone to headache.
The documentation pack a regulator actually asks for.
Every nicorandil consignment ships with a batch-specific certificate of analysis, a certificate of pharmaceutical product, and the sourcing manufacturer's WHO-GMP certification, since M Care sources exclusively from WHO-GMP certified Indian manufacturers rather than holding manufacturing status itself. Stability data is included matching the tablet's sensitivity to heat and humidity, and packaging is blister-strip with foil backing to protect that stability profile in transit. Because nicorandil carries a specific ulceration warning in every market that licenses it, some import authorities request confirmation that the accompanying package insert or product information reflects that warning in the language and format their national regulator requires; we coordinate this with the sourcing manufacturer on a per-enquiry basis rather than holding a generic dossier. M Care's own documentation carries our ISO 9001:2015 quality management certification and CDSCO export licence, which cover our merchant-export operation, not the manufacturing site. We do not claim WHO-GMP or WHO-PQ status for M Care itself, and we do not supply nicorandil into any market where it does not hold an active local marketing authorisation.
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.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Not approved by the US FDA; not marketed in the United States
Second-line agent by label in all licensing markets (UK, EU, Japan, Australia, New Zealand): restricted to patients inadequately controlled by or intolerant of first-line anti-anginal therapy
Prominently highlighted risk of dose-related ulceration: mouth, gastrointestinal tract, skin, perianal, genital mucosa and eye; can progress to perforation, fistula, haemorrhage or abscess; often refractory except on drug withdrawal; permanent discontinuation required if ulceration occurs
Contraindicated with PDE5 inhibitors (sildenafil, tadalafil, vardenafil) and soluble guanylate cyclase stimulators (riociguat): risk of severe hypotension
Contraindicated in cardiogenic shock, severe hypotension, hypovolaemia, left ventricular failure with low filling pressure, and acute pulmonary oedema
Increased GI ulceration/perforation/haemorrhage risk with concomitant aspirin, other NSAIDs, or corticosteroids; particular caution in diverticular disease
Adjacent lines procurement desks order alongside nicorandil.
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 nicorandil.
- 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.
Nicorandil supply, the specific questions.
Is nicorandil approved by the US FDA?
No. Nicorandil has never received US FDA approval and is not marketed in the United States. It is licensed in the UK, the wider EU, Japan, Australia, New Zealand and a number of other markets, and M Care supplies it only into jurisdictions where it holds an active marketing authorisation.
Why is nicorandil restricted to second-line use for angina?
Regulators in every market that licenses nicorandil restrict it to patients whose stable angina is inadequately controlled by, or intolerant of, first-line therapies such as beta-blockers or calcium channel blockers. The restriction follows nicorandil's dose-related ulceration risk, which distinguishes it from other anti-anginal classes on the same formulary.
What ulceration risk does nicorandil carry, and how is it managed?
Nicorandil can cause ulceration of the mouth, gastrointestinal tract, skin, perianal or genital mucosa, and occasionally the eye, at any point during treatment. These ulcers are often refractory to standard treatment and generally resolve only when nicorandil is withdrawn; labelling across licensed markets calls for permanent discontinuation if ulceration develops. This is prescriber-facing safety information, not dosing guidance for patients.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care is a merchant exporter, not a manufacturer, so we do not hold WHO-GMP or WHO-PQ certification ourselves. Our nicorandil is sourced from WHO-GMP certified Indian manufacturers, and each consignment ships with that manufacturer's certification. M Care's own credentials are ISO 9001:2015 and a CDSCO export licence.
What strengths and dosage forms does M Care stock for nicorandil?
M Care's catalogue covers nicorandil oral tablets in 5mg, 10mg and 20mg strengths only, across 31 stocked lines. We do not stock nicorandil capsules, injections, oral suspensions or any other dosage form, and we do not represent that we can source those forms.
Which interactions should a buyer's regulatory or pharmacy team flag before importing nicorandil?
Concomitant use of phosphodiesterase-5 inhibitors or soluble guanylate cyclase stimulators is contraindicated due to severe hypotension risk, and aspirin, NSAIDs or corticosteroids taken alongside nicorandil raise the risk of gastrointestinal ulceration and perforation. These are label-level interactions relevant to procurement and formulary review, not dosing instructions for patients.
Can M Care supply nicorandil for the Indian market?
No. India is M Care's country of origin for sourcing, not a served market. We export nicorandil to licensed buyers in the UK, EU, Gulf and GCC states, Africa, Latin America, Southeast Asia and CIS markets where the molecule holds a marketing authorisation.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
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.