WHO-GMP sourced EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Coreg (carvedilol) is licensed for chronic heart failure, left ventricular dysfunction after myocardial infarction and hypertension, and FDA-approved generic carvedilol tablets are available alongside the originator brand.

Coreg (carvedilol), originated by GlaxoSmithKline, is a non-cardioselective beta-blocker with additional alpha-1 vasodilating activity, named by the WHO Expert Committee as a therapeutic alternative to bisoprolol for heart failure. M Care Exports is a merchant exporter: we source the originator brand and FDA-approved generic carvedilol tablets 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

Carvedilol exporter and bulk supplier from India.

For hospital, wholesaler and tender-desk orders, M Care quotes carvedilol tablets against buyer specification: brand (Coreg) or generic, strength mix (3.125 mg, 6.25 mg, 12.5 mg, 25 mg) and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because carvedilol's twice-daily immediate-release tablet and the once-daily Coreg CR extended-release capsule are distinct, non-interchangeable formulations, we confirm which one a tender or formulary line specifies before we release a quote, 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.

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At a glance

Non-cardioselective beta-1/beta-2 adrenergic antagonist with additional alpha-1 blocking (vasodilating) activity, sourced and documented for export.

Carvedilol is a non-cardioselective beta-1 and beta-2 adrenergic antagonist that also blocks alpha-1 receptors, giving it a vasodilating effect that plain beta-blockers such as bisoprolol or metoprolol do not have. That third mechanism is the clinical rationale hospital cardiology services give for choosing it in heart failure with reduced ejection fraction. Coreg's FDA-labelled indications are mild-to-severe chronic heart failure of ischaemic or cardiomyopathic origin, reduction of cardiovascular mortality after a myocardial infarction in patients with left ventricular ejection fraction of 40% or below, and management of essential hypertension. The UK generic SmPC for carvedilol additionally licenses long-term management of stable angina pectoris, so destination-country labelling should be checked against the tender specification before a quote is finalised. Coreg immediate-release tablets are supplied at 3.125 mg, 6.25 mg, 12.5 mg and 25 mg, taken twice daily with food to reduce orthostatic hypotension risk; a separate once-daily extended-release capsule (Coreg CR, carvedilol phosphate, 10-80 mg) exists as a distinct originator formulation.

Active ingredient

carvedilol. Non-cardioselective beta-1/beta-2 adrenergic antagonist with additional alpha-1 blocking (vasodilating) activity.

Forms and strengths

3.125 mg film-coated tablet; 6.25 mg film-coated tablet; 12.5 mg film-coated tablet; 25 mg film-coated tablet.

Indications

Non-cardioselective beta-blocker with alpha-1 vasodilating activity, licensed for chronic heart failure, post-myocardial-infarction left ventricular dysfunction and hypertension, titrated over weeks and taken with food to limit orthostatic hypotension.

Administration

oral. Film-coated tablet, taken twice daily with food.

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 carvedilol are mainly hospital cardiology and heart-failure pharmacies running guideline-directed medical therapy formularies, national and regional MoH tender desks specifying beta-blockers for cardiovascular disease programmes, licensed pharmaceutical wholesalers and importers, and NGO or foundation procurement programmes supporting non-communicable-disease access in markets where local registration is in place.

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 carvedilol.

Carvedilol is titrated, not started at target: heart-failure dosing begins at 3.125 mg twice daily and is doubled no more often than every two weeks, to a maximum of 25 mg twice daily under 85 kg or 50 mg twice daily over 85 kg, as tolerated by heart rate and blood pressure. The counselling point that matters most at dispensing is administration with food, which slows absorption and blunts the peak plasma concentration responsible for first-dose and up-titration orthostatic hypotension; patients should be warned against driving for the first hour after a new or increased dose. Carvedilol is contraindicated in bronchial asthma or bronchospastic disease, second- or third-degree AV block without a pacemaker, severe bradycardia, decompensated heart failure needing IV inotropes, and severe hepatic impairment. Medicines reconciliation should also flag abrupt discontinuation: stopping carvedilol suddenly, particularly in ischaemic heart disease, can precipitate exacerbated angina, myocardial infarction or ventricular arrhythmia, so tapering over one to two weeks is standard practice. As an oral solid dosage form it needs no cold chain, but the twice-daily immediate-release tablet and the once-daily Coreg CR capsule must never be substituted for one another on a formulary without a prescriber decision.

Regulatory & quality

The documentation pack a regulator actually asks for.

As an oral solid dosage form, carvedilol travels on standard ambient-temperature logistics rather than the cold-chain lanes we validate for biologics; the UK SmPC specifies storage below 30°C with a three-year shelf life at manufacture, which we build into dispatch planning against the buyer's remaining-shelf-life requirement. Carvedilol is not itself on the WHO Model List of Essential Medicines, but the WHO Expert Committee lists it as a therapeutic alternative to bisoprolol, the nominated beta-blocker, for heart failure, on the strength of randomised-trial evidence reviewed alongside metoprolol; tender desks specifying a beta-blocker for heart-failure programmes can reasonably substitute carvedilol where bisoprolol is unavailable or clinically unsuitable. On the brand-versus-generic question, GlaxoSmithKline's Coreg (US) remains the reference brand, but the FDA approved the first generic carvedilol tablets in 2007 and multiple manufacturers now supply FDA-approved generic carvedilol immediate-release tablets, so buyers genuinely have a brand-or-generic choice; M Care quotes either against the tender specification and destination-market registration status. Carvedilol is not a controlled substance in any market we ship to. Buyers should note that carvedilol tablets currently appear on the FDA's active drug shortage database, which we treat as a live example of why formulary desks keep a secondary export source on file even for an established generic beta-blocker.

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 carvedilol.
  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

Carvedilol supply, the specific questions.

Does a generic version of Coreg exist?

Yes. The FDA approved the first generic carvedilol tablets in 2007, and FDA-approved generic carvedilol immediate-release tablets from multiple manufacturers are now registered and marketed alongside GlaxoSmithKline's Coreg. Registration status for generic carvedilol varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.

Can M Care supply Coreg to our market?

Yes, on an import basis. We source Coreg and FDA-approved generic carvedilol tablets through licensed Indian distribution channels and dispatch against your import authorisation and any local registration your pharmacy or hospital holds.

What strengths of carvedilol tablets are available?

3.125 mg, 6.25 mg, 12.5 mg and 25 mg immediate-release film-coated tablets, matching the Coreg strengths. Tell us your titration protocol and patient population and we quote the strength mix accordingly.

Is carvedilol interchangeable with the once-daily Coreg CR capsule?

No. The twice-daily immediate-release tablet and the once-daily Coreg CR extended-release capsule (carvedilol phosphate) are distinct formulations with different release profiles and are not substituted for one another on a formulary without a prescriber decision. M Care quotes the immediate-release tablet unless a tender specifically requests the extended-release capsule.

Is carvedilol on the WHO Essential Medicines List?

Not directly. The WHO Expert Committee lists carvedilol as a therapeutic alternative to bisoprolol, its nominated square-box beta-blocker for heart failure, alongside metoprolol, on the basis of randomised-trial evidence. Tender desks specifying a beta-blocker for heart-failure programmes can reasonably substitute carvedilol where bisoprolol is unavailable or unsuitable.

Why must carvedilol be taken with food and not stopped suddenly?

Food slows absorption and blunts the peak plasma level responsible for orthostatic hypotension, particularly at the first dose or after an up-titration. Stopping carvedilol abruptly, especially in patients with ischaemic heart disease, can precipitate exacerbated angina, myocardial infarction or ventricular arrhythmia, so it is tapered over one to two weeks when discontinued.

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 2026-09-13.

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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