Cilnidipine blocks N-type calcium channels alongside L-type, which is why prescribers ask for it by name when amlodipine-induced ankle oedema, the single most common reason amlodipine therapy gets switched, forces a change, and M Care Exports supplies the oral tablet lines that switch requires.
Ankle oedema is the most common reason a patient's amlodipine therapy gets switched, and cilnidipine's N-type calcium channel blockade, alongside the L-type action it shares with amlodipine, is why prescribers ask for it by name in that switch. M Care Exports supplies the oral tablet lines, 5mg, 10mg and 20mg, sourced from WHO-GMP certified Indian manufacturers, with the batch documentation regulatory affairs teams need to bring the molecule into a licensed formulary.
Cilnidipine exporter and bulk supplier from India.
Cilnidipine ships as oral tablets in standard blister strips, with no cold chain or special handling requirement. M Care coordinates CDSCO export documentation, packing lists and commercial invoicing for air or sea freight, and supplies batch-specific certificates of analysis and a manufacturer's Certificate of Pharmaceutical Product with every shipment. Because the purchasing case for cilnidipine rests on its N-type profile against amlodipine rather than an established reference approval, buyers should expect the accompanying technical package, stability data matched to the destination's climatic zone and impurity profiles, to support a stand-alone national registration built from evidence rather than a reliance filing.
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.
Dihydropyridine calcium channel blocker (dual L-type and N-type), sourced and documented for export.
Cilnidipine blocks both L-type calcium channels in vascular smooth muscle and N-type channels in sympathetic nerve terminals. That added N-type action dampens the reflex sympathetic activation that L-type-only agents such as amlodipine can trigger, and it is the reason prescribers reach for cilnidipine by name when ankle and pedal oedema, the single most common reason amlodipine therapy gets switched, becomes the limiting factor. Comparative trial data report pedal oedema rates several times lower with cilnidipine than amlodipine at comparable blood pressure control (one head-to-head study recorded 6.7% versus 63.3%), alongside a lower plasma aldosterone response and an anti-proteinuric signal relevant to hypertensive patients with chronic kidney disease. M Care Exports supplies the oral tablet lines, 5mg, 10mg and 20mg, sourced from WHO-GMP certified Indian manufacturers, across 27 stocked lines.
Active ingredient
Cilnidipine. Dihydropyridine calcium channel blocker (dual L-type and N-type).
Forms and strengths
5 mg; 10 mg; 20 mg.
Indications
Cilnidipine is a dihydropyridine calcium channel blocker that blocks both L-type calcium channels in vascular smooth muscle and N-type calcium channels in sympathetic nerve terminals, used for essential hypertension. The added N-type action is associated with lower rates of ankle and pedal oedema than L-type-only agents such as amlodipine. It carries no FDA or EMA marketing authorisation; its approvals are limited to Japan, China, Korea, India and Nepal.
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.
Cilnidipine's buyer base is built around formulary and tender decisions rather than first-line prescribing. Licensed importers and hospital procurement teams in the Gulf and GCC, African markets, Southeast Asia, Latin America and CIS states raise it when a prescriber wants an alternative to amlodipine without losing blood pressure control, most often after ankle or pedal oedema becomes the limiting side effect. UK and EU regulatory affairs teams and tender desks treat it as a registration project worth the stand-alone dossier work, given the purchasing case the N-type profile makes with prescribers. India is M Care's country of manufacture, never a served market.
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 cilnidipine.
A pharmacist reviewing cilnidipine checks the dual-channel pharmacology first: L-type blockade gives the antihypertensive effect common to the dihydropyridine class, while N-type blockade at sympathetic nerve terminals suppresses the reflex tachycardia and catecholamine surge that L-type-only agents such as amlodipine can trigger. That is the basis for the lower reported incidence of ankle and pedal oedema, with at least one head-to-head trial recording pedal oedema in 6.7% of patients on cilnidipine against 63.3% on amlodipine at comparable blood pressure control; rates vary by study design and are not zero. Cilnidipine is metabolised hepatically, largely via CYP3A4, so a review should flag interacting inducers or inhibitors of that pathway. Severe hepatic impairment requires caution and a more conservative dose given reduced clearance, and fixed-dose combination products containing cilnidipine carry an explicit contraindication in severe hepatic failure, a distinction worth noting since M Care's cilnidipine catalogue is single-ingredient tablets only. The anti-proteinuric signal seen in chronic kidney disease cohorts is attributed to reduced glomerular sympathetic tone rather than a distinct renal mechanism, and renal dosing guidance should be confirmed against the manufacturer's current prescribing information. Formulary reviewers positioning it against amlodipine should treat it as a therapeutic alternative for oedema-intolerant patients, not a superior first-line agent, since outcome trial data remain smaller in scale than the amlodipine evidence base.
The documentation pack a regulator actually asks for.
M Care operates as a merchant-exporter, not a manufacturer, and holds ISO 9001:2015 certification and a CDSCO export licence; it does not hold WHO-GMP or WHO-PQ certification directly, since those apply to the manufacturing site, not the exporter. Cilnidipine is sourced only from WHO-GMP certified Indian manufacturing units, and every shipment carries a batch-specific certificate of analysis and a manufacturer's Certificate of Pharmaceutical Product. Cilnidipine's marketing authorisations sit in Japan, China, Korea, India and Nepal, with no FDA or EMA approval to reference, so buyers registering it elsewhere should plan for a full stand-alone dossier. Full CTD Module 3 data, stability studies against the destination's climatic zone and impurity profiles are available on request from the manufacturing partner, and buyers should confirm current requirements with their national regulator before committing to a tender.
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.
No FDA approval; cilnidipine is not marketed or available in the United States.
No EMA or UK MHRA marketing authorisation; not approved in the EU or UK.
Marketing authorisations exist only in Japan, China, Korea, India and Nepal; these do not transfer automatically to importing countries.
M Care Exports is a merchant-exporter, not a manufacturer, and sources cilnidipine from WHO-GMP certified Indian manufacturers.
M Care holds ISO 9001:2015 certification and a CDSCO export licence; it does not hold WHO-GMP or WHO-PQ certification directly.
Prescription-only medicine; severe hepatic impairment requires caution and closer monitoring due to reduced hepatic clearance, and fixed-dose combination products containing cilnidipine carry an explicit contraindication in severe hepatic failure.
Adjacent lines procurement desks order alongside cilnidipine.
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 cilnidipine.
- 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.
Cilnidipine supply, the specific questions.
Why do prescribers switch patients from amlodipine to cilnidipine?
Cilnidipine blocks N-type calcium channels in addition to the L-type channels amlodipine blocks, which dampens the reflex sympathetic activation behind dose-dependent ankle and pedal oedema, the most common reason amlodipine therapy gets switched. Comparative trial data report substantially lower oedema rates with cilnidipine at comparable blood pressure control, which is the clinical reason procurement teams are asked to source it as an amlodipine alternative.
How much lower is cilnidipine's oedema rate compared with amlodipine's?
Published comparative studies report lower rates of ankle and pedal oedema with cilnidipine than amlodipine; one head-to-head trial recorded pedal oedema in 6.7% of patients on cilnidipine against 63.3% on amlodipine at comparable blood pressure control. Rates vary across trial designs and are not zero, so this is a comparative signal for formulary discussion rather than a claim of freedom from oedema.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care Exports is a merchant-exporter and holds ISO 9001:2015 certification and a CDSCO export licence. WHO-GMP and WHO-PQ certify manufacturing sites, not exporters or traders, so M Care sources cilnidipine only from WHO-GMP certified Indian manufacturers and passes through their certificates and batch documentation rather than claiming those credentials itself.
Which countries have cilnidipine registered, and what does that mean for a buyer elsewhere?
Cilnidipine's marketing authorisations sit in Japan, China, Korea, India and Nepal. It carries no FDA or EMA marketing authorisation, so buyers in the UK, EU, Gulf, African, Latin American or CIS markets M Care serves should plan for a full stand-alone registration dossier rather than a reliance or mutual-recognition pathway.
What dosage forms and strengths does M Care supply for cilnidipine?
M Care supplies cilnidipine as an oral tablet only, in 5mg, 10mg and 20mg strengths across 27 stocked lines, all single-ingredient formulations with no fixed-dose combination products currently in the catalogue. Capsule, injectable and other dosage forms exist in the wider clinical literature but are not part of M Care's current cilnidipine range.
What documentation does M Care provide to support a stand-alone registration dossier?
Each shipment carries a batch-specific certificate of analysis and a manufacturer's Certificate of Pharmaceutical Product. Full CTD Module 3 data, stability studies matched to the destination's climatic zone and impurity profiles are available on request from the manufacturing partner, since a cilnidipine registration outside Japan, China, Korea, India and Nepal is typically built as a complete, evidence-led submission.
Is cilnidipine safe for patients with hepatic impairment?
Cilnidipine is metabolised primarily by hepatic CYP3A4, and severe hepatic impairment requires caution and a more conservative, closely monitored dose because clearance is reduced. Fixed-dose combination products containing cilnidipine carry an explicit contraindication in severe hepatic failure; M Care's cilnidipine catalogue is single-ingredient tablets only. This is a clinical prescribing consideration for the treating physician, not a patient dosing instruction, and current contraindication status should be confirmed against the manufacturer's prescribing information.
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.
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