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

Ramipril, sold under the Sanofi originator brand Tritace or as a generic capsule or tablet, is licensed for hypertension, for reducing cardiovascular events in high-risk patients, and for heart failure that develops after a myocardial infarction. The US originator brand Altace has since been discontinued, leaving generic ramipril as the US market's brand-equivalent.

M Care Exports is a merchant exporter, not a manufacturer: we source ramipril, an off-patent ACE inhibitor, through licensed Indian channels as originator-linked Tritace stock (Sanofi's current EU/UK brand) where the buyer specifies it, or as FDA- and MHRA-registered generic ramipril, and dispatch against a hospital, wholesaler or tender-desk order. The US originator brand Altace has been discontinued and is no longer in production.

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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

Ramipril exporter and bulk supplier from India.

We're looking for a supplier who can quote ramipril at scale, not just spot-fill one strength: that's the brief we hear most often from tender desks and hospital pharmacy buyers.

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

Angiotensin-converting enzyme (ACE) inhibitor, sourced and documented for export.

Ramipril is an angiotensin-converting enzyme (ACE) inhibitor: it blocks conversion of angiotensin I to angiotensin II, lowering peripheral vascular resistance and blood pressure while reducing cardiac workload. It has been off-patent for years and is manufactured worldwide as a generic alongside the Tritace originator brand; the US originator brand Altace has since been discontinued. It carries three separate licensed indications, each with its own titration schedule. For hypertension, dosing starts at 2.5 mg once daily and is adjusted every two to four weeks to a maintenance range of 2.5-20 mg daily. For cardiovascular risk reduction in patients 55 and over with existing vascular disease or diabetes plus risk factors, dosing starts at 2.5 mg for one week, rises to 5 mg for three weeks, then to a 10 mg daily maintenance dose. For heart failure following a myocardial infarction, dosing starts at 2.5 mg twice daily, dropping to 1.25 mg twice daily if the patient becomes hypotensive, and titrates toward 5 mg twice daily. In patients with renal impairment, the hypertension starting dose is reduced to 1.25 mg once daily. Ramipril is supplied as capsules or as Tritace-brand tablets (Sanofi, the current EU/UK originator), an oral solid dosage form with no reconstitution step. The dosing above follows US FDA labelling; the Tritace SmPC used across M Care's EU/UK markets sets a lower heart-failure starting dose (1.25 mg once daily) and a lower hypertension ceiling (10 mg daily), so buyers should confirm the regimen against destination-country labelling.

Active ingredient

Ramipril. Angiotensin-converting enzyme (ACE) inhibitor.

Forms and strengths

1.25 mg capsule or tablet; 2.5 mg capsule or tablet; 5 mg capsule or tablet; 10 mg capsule or tablet.

Indications

Ramipril is an ACE inhibitor licensed for hypertension, for reducing cardiovascular events in high-risk patients aged 55 and over, and for stable heart failure following an acute myocardial infarction. Supplied as generic capsules or as Tritace-brand tablets (Sanofi, the current EU/UK originator) from Indian WHO-GMP facilities to regulated and semi-regulated export markets; the US originator brand Altace has been discontinued.

Administration

Oral. Capsule or tablet.

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.

We hear from hospital pharmacy procurement teams stocking a formulary-standard ACE inhibitor, MoH tender desks running annual or biannual cardiovascular-medicine lists, licensed wholesalers and importers who need a dependable high-volume generic line rather than a one-off order, and NGO or public-health programme buyers sourcing the ACE-inhibitor component of secondary cardiovascular-prevention protocols. Most are comparing Tritace brand-name stock against generic ramipril on price and registration status, not choosing between different molecules; the US originator brand Altace has been discontinued and is no longer part of that comparison.

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 ramipril.

Ramipril has three distinct dosing ladders, not one, and a tender specification that just says "ramipril" without naming the indication is incomplete: hypertension titrates from 2.5 mg to a 2.5-20 mg maintenance range, cardiovascular risk reduction climbs 2.5 mg to 5 mg to a 10 mg target over four weeks, and post-MI heart failure starts at 2.5 mg twice daily and steps down to 1.25 mg twice daily if the patient becomes hypotensive. Confirm which regimen the order is quoting against before packing the strength mix. Renal function matters more than for most oral antihypertensives: the hypertension starting dose is halved to 1.25 mg once daily in renal impairment, and first-dose hypotension is a recognised class effect, so counsel diuretic-treated patients accordingly. There's no reconstitution and no cold chain here: ramipril capsules and tablets are stored at controlled room temperature, so this is a standard ambient-logistics line, unlike the biologics we also move on validated cold-chain lanes. Note that the ladders above follow US labelling; the Tritace SmPC used in our EU/UK markets sets a lower heart-failure starting dose, so confirm against destination-country labelling before quoting.

Regulatory & quality

The documentation pack a regulator actually asks for.

Ramipril ships on standard ambient, moisture-controlled freight; there's no cold-chain validation step to build into the shipping dossier, which keeps the logistics side simpler than for our biologic lines. What buyers should check instead is registration status for the specific presentation they want: generic capsule or tablet versus Tritace-brand tablet, since both differ by destination market. The US originator brand Altace has been discontinued (per FDA's Drugs@FDA record for NDA 019901, all four strengths marked "Discontinued") and is no longer in production, so Tritace and generic ramipril are the two live brand-or-generic options we quote against. On the brand-versus-generic question, ramipril has long been off-patent and FDA- and MHRA-registered generic capsules and tablets are widely available alongside the Tritace originator brand, so buyers genuinely have a brand-or-generic choice; we quote either against the tender specification. Ramipril is also one of the three active ingredients, alongside aspirin and atorvastatin, in the fixed-dose cardiovascular polypill the WHO added to its Model List of Essential Medicines in 2023 for secondary prevention of atherosclerotic disease, which is increasingly relevant to public-health procurement lists in our Africa and GCC markets.

Buyers new to sourcing from India usually read the licensed import route explainer first, then the product page.

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 ramipril.
  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

Ramipril supply, the specific questions.

Can M Care supply Altace or Tritace, or only generic ramipril?

Tritace and generic ramipril, on request. We source Tritace, Sanofi's current EU/UK originator brand, through licensed Indian distribution channels where a buyer specifies it, and FDA- or MHRA-registered generic ramipril capsules or tablets where price or tender rules call for a generic. The US originator brand Altace has been discontinued and is no longer in production, so it isn't part of current sourcing. Tell us which the specification requires and we quote accordingly.

What strengths of ramipril does M Care stock?

1.25 mg, 2.5 mg, 5 mg and 10 mg, matching the labelled Tritace strengths, across both capsule and tablet presentations. Send us your dosing protocol or tender line item and we quote the strength mix you need.

Is ramipril a cold-chain product?

No. It's an oral solid dosage form stored at controlled room temperature, so it moves on standard ambient, moisture-controlled logistics rather than the validated cold-chain lanes we use for biologics.

What is ramipril licensed to treat?

Three separate indications: hypertension, reduction of myocardial infarction, stroke or cardiovascular death in patients aged 55 or over at high vascular risk, and stable heart failure that develops within days of an acute myocardial infarction. Each has its own dosing ladder, and the exact starting dose can differ between the US FDA label and the Tritace SmPC used in our EU/UK markets, so confirm which indication and which destination-market labelling your order is quoting against.

Does ramipril require any special renal-dosing adjustment?

Yes. In patients with renal impairment, the recommended hypertension starting dose is halved to 1.25 mg once daily, with careful upward titration. First-dose hypotension is a recognised ACE-inhibitor class effect, particularly in patients already on a diuretic.

What documentation does M Care provide with a ramipril shipment?

CTD/eCTD-aligned dossier documentation, certificates of analysis and batch records, plus CDSCO export paperwork from the Indian side, matched to whichever destination-market import requirements apply to the capsule or tablet presentation you've ordered.

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 2026-09-11.

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.

Ramipril enquiry

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.

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