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Cardizem, sold in the UK and EU as Tildiem, is a non-dihydropyridine calcium channel blocker licensed for hypertension and angina in oral modified-release form and, as a separate intravenous formulation, for temporary rate control in atrial fibrillation and flutter, and FDA and MHRA-approved generic diltiazem tablets, capsules and injection are available alongside the originator brands.

Cardizem, marketed in the UK and EU as Tildiem, is a non-dihydropyridine calcium channel blocker: an oral tablet or capsule for hypertension and angina, and a separate intravenous formulation hospitals use to control rapid ventricular rate in atrial fibrillation and flutter. M Care Exports is a merchant exporter: we source the Bausch Health and Sanofi brands and FDA and MHRA-approved generic diltiazem tablets, capsules and injection through licensed Indian distribution and manufacturing channels, and dispatch on quote, not from our own manufacturing.

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WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
Bulk supply and export terms

Diltiazem exporter and bulk supplier from India.

For hospital cardiology, ICU and tender-desk orders, M Care quotes diltiazem against buyer specification: oral modified-release tablets or capsules for outpatient hypertension and angina management, or intravenous diltiazem for inpatient rate control, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. The injectable form carries two extra procurement considerations the oral forms do not: it needs cold-chain storage and transit (labelled for 2-8C refrigeration, with only up to one month permitted at room temperature before the vial must be discarded), and it is listed as an active shortage at the time of writing (September 2026) on the FDA drug shortage database with supply drawn from a small number of manufacturers, so we confirm current allocation status and cold-chain logistics with the sourcing partner before quoting IV lines, while oral tablets and capsules need no cold chain and remain broadly available across brand and generic channels.

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.

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At a glance

Non-dihydropyridine calcium channel blocker (benzothiazepine class), sourced and documented for export.

Diltiazem is a non-dihydropyridine calcium channel blocker of the benzothiazepine class. It slows conduction through the AV node and relaxes vascular and coronary smooth muscle, lowering blood pressure and easing both exertional and vasospastic angina. Cardizem/Tildiem's flagship oral indications are hypertension (extended-release tablets and capsules) and chronic stable or vasospastic (Prinzmetal's) angina (immediate-release tablets), while a separate intravenous formulation is licensed for temporary rate control of rapid ventricular response in atrial fibrillation and atrial flutter, an inpatient, rate-control use the oral forms do not share. Oral strengths run from 30 mg immediate-release tablets to 420 mg once-daily extended-release tablets; injection is supplied as a 5 mg/mL solution in single-dose vials.

Active ingredient

Diltiazem hydrochloride. Non-dihydropyridine calcium channel blocker (benzothiazepine class).

Forms and strengths

30 mg immediate-release tablet; 60 mg modified-release tablet; 200 mg prolonged-release capsule; 300 mg extended-release tablet; 5 mg/mL solution for injection (single-dose vial).

Indications

Diltiazem hydrochloride, a non-dihydropyridine calcium channel blocker indicated for hypertension and angina in oral modified-release form, and for temporary rate control of atrial fibrillation and flutter as a separate intravenous formulation. Supplied as originator Cardizem/Tildiem and licensed generic tablets, capsules and injection from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.

Administration

Oral, Intravenous. Immediate-release and modified/extended-release tablet or capsule (oral); solution for injection (intravenous).

Documentation

Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.

Who we supply

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 diltiazem split by care setting: hospital cardiology and internal-medicine pharmacies stocking oral tablets and capsules for outpatient hypertension and angina, and ICU or emergency-department pharmacies and procurement desks sourcing the intravenous formulation for acute atrial fibrillation and flutter rate control. National and regional MoH tender desks running cardiovascular formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or foundation procurement programmes supporting hypertension management in markets where local registration is in place also buy from us.

GCC registration routes

Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.

MoH registration, GCC →

UK unlicensed routes

Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.

MHRA Specials →

Tender desks

Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.

Tender response →

Dossier support

CTD documentation from the sourcing manufacturer, compiled for your regulator's format.

Dossier preparation →

Pharmacist's note

What the dispensing pharmacist checks on diltiazem.

Diltiazem's oral forms are not interchangeable: the 30-120 mg immediate-release tablet is dosed three to four times daily for angina, while extended-release tablets and capsules (Cardizem LA, Cardizem CD, Tildiem Retard/LA) are titrated once daily up to 540 mg for hypertension, so a tender specifying 'diltiazem tablets' should confirm which release profile the formulary actually stocks. Intravenous diltiazem is dosed differently again: an initial weight-based bolus of 0.25 mg/kg over two minutes, with a second bolus of 0.35 mg/kg after 15 minutes if the response is inadequate, sometimes followed by continuous infusion, and it is contraindicated where an accessory pathway such as Wolff-Parkinson-White syndrome is present, since it can precipitate a life-threatening rise in heart rate. Sick sinus syndrome, second- or third-degree AV block without a pacemaker, and severe bradycardia are contraindications across every dosage form. The oral tablets and capsules need no cold chain and are stored at room temperature, but the intravenous formulation is different: it is labelled for storage under refrigeration (2-8C), room-temperature storage is permitted for only up to one month before the vial must be discarded, and freezing must be avoided throughout, so IV allocations carry cold-chain logistics the oral forms do not. Hepatic or renal impairment, and elderly patients, warrant a lower starting dose.

Regulatory & quality

The documentation pack a regulator actually asks for.

Diltiazem travels on standard ambient-temperature logistics for the oral tablets and capsules. The intravenous formulation is different: FDA-approved diltiazem injection is labelled for refrigerated storage (2-8C), with room-temperature storage permitted for only up to one month before the vial must be discarded, so IV orders need cold-chain packaging and transit that the oral forms do not. What buyers need 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. Diltiazem does not appear on the current WHO Model List of Essential Medicines; amlodipine holds the list's core antihypertensive calcium-channel-blocker entry, so diltiazem functions as a formulary-specific tender line rather than a pooled-procurement first-line agent, useful chiefly where a buyer's protocol calls for the rate-control or vasospastic-angina cover a dihydropyridine does not provide. On the brand-versus-generic question, Cardizem (US, Bausch Health) and Tildiem (UK/EU, Sanofi) remain the originator products; FDA and MHRA-approved generic diltiazem tablets, capsules and injection from multiple manufacturers are separately registered in the US, UK and EU, so buyers have a genuine brand-or-generic choice for oral therapy. The intravenous formulation is a different story on supply too: it is listed as an active shortage at the time of writing (September 2026) on the FDA drug shortage database, with allocation-based distribution from a small number of active manufacturers, so M Care confirms current supply, lead time and cold-chain logistics with the sourcing partner before quoting IV lines rather than assuming standard availability.

Permit sequence, registration status and customs handling are documented in importing medicines from India through the licensed route; this page sticks to what is specific to the molecule.

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.

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Form and strength, pack preference, destination market and indicative volume for diltiazem.
  2. We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
  3. Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
  4. Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
  5. After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Frequently asked

Diltiazem supply, the specific questions.

Does a generic version of Cardizem/Tildiem exist?

Yes. FDA and MHRA-approved generic diltiazem tablets, extended-release capsules and injection are registered and marketed in the US, UK and EU alongside the originator brands Cardizem and Tildiem. Registration status varies by destination country and dosage form, so M Care checks local approval before quoting brand or generic against a specific tender.

Can M Care supply Cardizem or Tildiem to our market?

Yes, on an import basis. We source Cardizem/Tildiem through Bausch Health and Sanofi's licensed Indian distribution channels and dispatch against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds.

What strengths and dosage forms of diltiazem are available?

Immediate-release tablets from 30 mg to 120 mg for angina dosed several times daily, once-daily extended-release tablets and capsules from 120 mg to 420 mg for hypertension, and a 5 mg/mL solution for injection in single-dose vials for inpatient rate control, which needs cold-chain (2-8C) storage and transit unlike the oral forms. Tell us your indication and dosing protocol and we quote the matching form and strength.

Why would a formulary specify diltiazem over a dihydropyridine calcium channel blocker like amlodipine?

Diltiazem slows conduction through the AV node, which amlodipine and other dihydropyridines do not do to a clinically useful degree, so it is the calcium channel blocker of choice for rate control in atrial fibrillation or flutter and for vasospastic (Prinzmetal's) angina. It is not on the WHO Essential Medicines List, which lists amlodipine as the core antihypertensive calcium-channel-blocker entry, so tender desks typically specify diltiazem for this rate-control or vasospastic-angina niche rather than as a first-line antihypertensive.

Is intravenous diltiazem reliably available?

Not as reliably as the oral forms. Diltiazem hydrochloride injection is listed as an active shortage at the time of writing (September 2026) on the FDA drug shortage database, with only a small number of active manufacturers supplying vials on allocation, and it also needs cold-chain storage (2-8C refrigeration, with only up to one month permitted at room temperature) that the oral forms do not. Oral tablets and capsules have no equivalent national shortage and need no cold chain. M Care confirms current lead time, allocation status and cold-chain logistics with the sourcing partner before quoting IV lines.

What should a tender desk know about diltiazem and heart block or Wolff-Parkinson-White syndrome?

Diltiazem, oral or intravenous, is contraindicated in sick sinus syndrome and second- or third-degree AV block without a functioning pacemaker, and in severe bradycardia. The intravenous form carries an additional warning: it should not be used in atrial fibrillation or flutter associated with an accessory pathway such as Wolff-Parkinson-White syndrome, since it can precipitate a life-threatening rise in heart rate. This should be flagged clearly on any dispensing or administration record.

Sources and review

Who stands behind this page, and where its statements come from.

Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-14.

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.

Diltiazem enquiry

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