Coniel (benidipine), a triple L-, T- and N-type calcium channel blocker developed in Japan, is licensed for hypertension and angina pectoris, and M Care sources both the originator line and generic benidipine hydrochloride tablets from Indian WHO-GMP manufacturers for buyers running country-specific registration or named-patient import.
M Care Exports supplies benidipine hydrochloride, sold by originator Kyowa Hakko Kirin as Coniel, an oral dihydropyridine calcium channel blocker licensed in Japan and separately in Turkey and China. As a merchant exporter, we do not manufacture; we source Coniel-equivalent generic benidipine tablets through licensed Indian WHO-GMP channels and dispatch against a buyer's own registration or import documentation, not from stock we hold ourselves.
Benidipine exporter and bulk supplier from India.
For hospital pharmacy, wholesaler and tender-desk enquiries, M Care quotes benidipine hydrochloride tablets against buyer specification: strength (2 mg, 4 mg or 8 mg), pack size and the destination regulator's dossier requirements, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because benidipine carries no FDA, EMA or MHRA approval and is not on most GCC or African formularies, we first confirm whether the buyer is importing on a named-patient or Specials-style basis or building a full country registration file, then align CTD/eCTD documentation to that route before dispatch.
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 (combined L-, T- and N-type blockade), sourced and documented for export.
Benidipine hydrochloride is a dihydropyridine calcium channel blocker distinguished from most drugs in its class by blocking L-, T- and N-type calcium channels together, alongside antimineralocorticoid activity that its originator has studied for a renoprotective effect. It is taken orally, needs no reconstitution and is not a controlled substance. Licensed in Japan as Coniel and separately in Turkey (as Coniel, via Deva) and China, it treats hypertension, renal parenchymal hypertension and, at a higher twice-daily dose, angina pectoris. It is supplied as 2 mg, 4 mg and 8 mg tablets, usually dosed once daily after breakfast for hypertension and twice daily for angina, with the Turkish label limiting use in cardiogenic shock and in pregnancy. Benidipine is not listed on the WHO Model List of Essential Medicines, unlike amlodipine, so most buyer formularies do not carry it as a standing line.
Active ingredient
Benidipine hydrochloride. Dihydropyridine calcium channel blocker (combined L-, T- and N-type blockade).
Forms and strengths
2 mg tablet; 4 mg tablet; 8 mg tablet.
Indications
Benidipine hydrochloride is a dihydropyridine calcium channel blocker that combines L-, T- and N-type calcium channel blockade with antimineralocorticoid activity. Licensed in Japan as Coniel and licensed separately in Turkey and China, it treats hypertension, renal parenchymal hypertension and angina pectoris. It holds no FDA, EMA or MHRA approval and is not on the WHO Model List of Essential Medicines. M Care sources generic benidipine hydrochloride tablets from Indian WHO-GMP manufacturers for export.
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 asking M Care for benidipine are typically hospital pharmacists managing a named-patient prescription for a Japanese, Turkish or East Asian expatriate patient, MoH tender desks evaluating whether to add a non-WHO-EML calcium channel blocker to a formulary, and licensed importers testing demand ahead of a full registration filing. India is our sourcing base, not a market we sell into; benidipine tablets are dispatched only to licensed buyers outside India. Because benidipine lacks a stringent-regulatory-authority approval to anchor a dossier, buyers usually need country-specific registration support or a named-patient/Specials import route rather than a standard tender listing, and M Care's Mumbai desk scopes that route before quoting.
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 benidipine.
Benidipine's dosing splits by indication, which trips up buyers used to a single once-daily CCB line: hypertension starts at 2 to 4 mg once daily after breakfast, titrating to 8 mg in resistant cases, while angina pectoris is dosed at 4 mg twice daily, after breakfast and dinner. The Turkish SmPC lists cardiogenic shock and pregnancy as contraindications, and warns against abrupt discontinuation, which can worsen anginal symptoms; taper rather than stop. There is no cold-chain requirement: tablets are stable at ambient conditions below 30 degrees C, with a 48-month shelf life at manufacture in Aluminium/PVC blister packs of 30. The clinical wrinkle for procurement, not the patient, is regulatory: with no FDA, EMA or MHRA licence and no WHO EML listing, a tender desk cannot lean on a stringent-regulatory-authority approval to fast-track registration, so budget for a full CTD dossier or a named-patient import route rather than a standard generic tender timeline.
The documentation pack a regulator actually asks for.
M Care is a merchant exporter, not a manufacturer: we source benidipine hydrochloride tablets from WHO-GMP-audited Indian manufacturing partners under our own CDSCO export licensure and ISO 9001:2015 quality system, and we do not hold or claim WHO-GMP or WHO-PQ status ourselves. Benidipine's own regulatory picture is narrower than most CCBs on our roster: it holds no FDA, EMA or MHRA marketing authorisation, so we treat every enquiry outside Japan, Turkey and China as a registration or named-patient project rather than an off-the-shelf tender line, and we compile CTD/eCTD documentation to the destination regulator's own requirements rather than assuming a reference-country approval exists to cite.
If your question is the route rather than the molecule, start with the licensed route for importing medicines from India and come back here for the product specifics.
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 benidipine.
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 benidipine.
- 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.
Benidipine supply, the specific questions.
We're looking for benidipine as Coniel or as a generic. Which can M Care supply?
Both, depending on the destination market's registration status. M Care sources generic benidipine hydrochloride tablets through licensed Indian WHO-GMP manufacturing channels; we do not supply Kyowa Hakko Kirin's own Coniel stock, since that is licensed separately in Japan, Turkey and China. Tell us your target market and we will confirm which route, generic export or a locally licensed originator product, actually applies there.
Is benidipine approved by the FDA, EMA or MHRA?
No. Benidipine has never held a US FDA, European EMA or UK MHRA marketing authorisation. It is licensed in Japan as Coniel and separately in Turkey and China. Buyers in GCC, African and European markets should plan for country-specific registration or a named-patient import route rather than assume an existing licence.
Is benidipine on the WHO Essential Medicines List?
No. The WHO Model List of Essential Medicines lists amlodipine among calcium channel blockers for hypertension; benidipine does not appear on the current list. A tender desk building an EML-anchored cardiovascular formulary would list benidipine as a supplementary or specialist line, not a core essential medicine.
How is benidipine dosed for hypertension compared with angina?
For hypertension, the standard dose is 2 to 4 mg once daily after breakfast, increasing to a maximum of 8 mg once daily in resistant cases. For angina pectoris, the licensed dose is 4 mg twice daily, after breakfast and after dinner. We confirm the buyer's intended indication before quoting a strength mix, since the two dosing patterns are not interchangeable.
Does benidipine need cold-chain shipping or special storage?
No. Benidipine hydrochloride tablets are stored below 30 degrees C at ambient conditions, with a shelf life of 48 months from manufacture, and are packed in Aluminium/PVC blister strips. No cold-chain logistics or reconstitution is required, which keeps freight and warehousing simpler than for an injectable line.
We need a partner for benidipine in a market where it isn't registered yet. Can M Care help?
Yes. Because benidipine lacks FDA, EMA or MHRA approval to anchor a fast-track filing, most GCC and African buyers approach it either through a named-patient or Specials-style import for individual patients, or by building a full country registration dossier from scratch. M Care's Mumbai desk compiles CTD/eCTD documentation from our Indian manufacturing partners to support either route, and scopes realistic timelines before you commit to a tender bid.
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.