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

Prevymis (letermovir) is an antiviral for CMV prophylaxis in transplant recipients, supplied as tablets, an IV concentrate and oral pellets, and dosed once daily with a lower dose when given with ciclosporin.

M Care Exports supplies Prevymis (letermovir), marketed by Merck Sharp & Dohme, to hospital pharmacies, transplant centres, importers and tender desks in the GCC, Africa and the UK. If you are looking for Prevymis tablets, the IV concentrate or the oral pellets, send the destination, the form and strength, and the quantity, and we quote per destination.

Prevymis 480 mg letermovir film-coated tablets carton (EU pack)
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

Letermovir exporter and bulk supplier from India.

"We need a partner for Prevymis" is a typical enquiry from a transplant unit or a tender desk. M Care is a merchant-exporter: we quote against your specification and confirm which presentation your destination registers. Prevymis comes as tablets, a concentrate for IV infusion and an oral form (pellets in the US, granules in sachet in the UK and EU), and the US label lists 240 mg and 480 mg tablets while the UK SmPC we read covers the 240 mg tablet, so the exact line matters. Prevymis does not need a cold chain, which keeps freight simpler than for biologicals. The quote turns on form, strength, pack, quantity and the registration route in the destination.

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.

Request a bulk quote → Send a bulk enquiry by form How bulk supply works
At a glance

Antiviral, CMV DNA terminase complex inhibitor, for cytomegalovirus (CMV) prophylaxis, sourced and documented for export.

Prevymis is a prescription antiviral, a CMV DNA terminase complex inhibitor, for prophylaxis of cytomegalovirus (CMV) in transplant recipients. The US label (Merck Sharp & Dohme LLC, revised January 2026) lists two indications: prophylaxis of CMV infection and disease in CMV-seropositive recipients of an allogeneic haematopoietic stem cell transplant (HSCT), with weight and age limits that include children, and prophylaxis of CMV disease in high-risk kidney transplant recipients (donor positive, recipient negative) aged 12 years and older and weighing at least 40 kg. The US dosage forms are tablets of 240 mg and 480 mg, single-dose injection vials of 240 mg/12 mL and 480 mg/24 mL (20 mg/mL), and oral pellets of 20 mg and 120 mg per packet. The UK emc listings show a 240 mg film-coated tablet and a 240 mg/12 mL concentrate for solution for infusion, with the same two indications, and refer to granules in sachet of 20 mg and 120 mg. The EMA page lists the EU marketing authorisation holder as Merck Sharp & Dohme B.V. and the authorisation date as 8 January 2018.

Active ingredient

Letermovir. Antiviral, CMV DNA terminase complex inhibitor, for cytomegalovirus (CMV) prophylaxis.

Forms and strengths

240 mg film-coated tablet; 480 mg tablet (US label); 240 mg/12 mL single-dose vial for IV infusion; 480 mg/24 mL single-dose vial for IV infusion (US label); 20 mg oral pellets per packet; 120 mg oral pellets per packet.

Indications

Letermovir (Prevymis) is a prescription antiviral used to prevent CMV infection and disease in allogeneic HSCT and kidney transplant recipients, as set out in the US, UK and EU labelling.

Administration

Oral, Intravenous. Film-coated tablet, concentrate for solution for infusion, oral pellets (granules in sachet in the UK and EU).

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 are hospital pharmacists in transplant and haematology units, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Prevymis 480 mg tablets for a transplant centre" or "We need a partner for letermovir injection for a tender". Each destination has its own route to registration or import, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria and the MHRA in the UK, and we align the offer with it before quoting. Tablets, the IV concentrate and the oral pellets or granules are separate lines with separate quantities.

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 letermovir.

Start with the ciclosporin rule. For adults and patients aged 12 and over above the label weight limits, the US label gives 480 mg once daily, orally or IV, and 240 mg once daily with ciclosporin. The dose is adjusted when ciclosporin is started or stopped: if ciclosporin is stopped, the dose returns to 480 mg, and no change is needed if ciclosporin is only interrupted for high levels. Duration differs by indication. In HSCT, prophylaxis starts between day 0 and day 28 and runs through day 100, and the US label allows continuing to day 200 for patients at risk of late CMV. In kidney transplant it starts between day 0 and day 7 and runs through day 200. The IV concentrate contains hydroxypropyl betadex, which can accumulate in renal impairment, so the US label advises close monitoring of serum creatinine when clearance is under 50 mL/min and keeping IV use to 4 weeks where possible. It must be diluted and given through a 0.2 or 0.22 micron in-line filter. Storage is 20 to 25 °C for all three forms in the US label, with the original package for moisture protection for tablets and the original carton for light protection for vials.

Regulatory & quality

The documentation pack a regulator actually asks for.

Prevymis is a room-temperature product. The US label gives 20 to 25 °C with excursions to 15 to 30 °C for tablets, pellets and vials. The UK emc tablet SmPC gives a 3-year shelf life, no special temperature condition and moisture protection, and the concentrate SmPC gives 3 years for the unopened vial with protection from light. The UK marketing authorisation holder is Merck Sharp & Dohme (UK) Limited, and the first UK authorisation date shown is 1 January 2021. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator requires it. We state the source and quality status of each line before quoting, and make no claim for M Care itself beyond merchant-exporter documentation.

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 letermovir.
  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

Letermovir supply, the specific questions.

What decides the landed price of Prevymis for an importer?

We do not publish prices. The landed cost depends on the form (tablet, IV concentrate or oral pellets), the strength, the pack, the quantity, the registration route in your destination and Incoterms. Prevymis needs no cold chain on the US and UK labels we read, so freight is simpler than for refrigerated products. M Care Exports quotes per destination once you send the form, strength, volume and country.

Is there a Prevymis generic or a generic letermovir?

We found no FDA-approved generic letermovir in the sources we checked. Lupin announced tentative FDA approval on 3 June 2024 for letermovir tablets of 240 mg and 480 mg, referencing Prevymis, and Drugs@FDA data also list a tentative approval for Zydus letermovir tablets. A tentative approval does not allow marketing. We did not confirm a generic in the EU or UK. If you are looking for letermovir, M Care Exports confirms availability of Prevymis and any letermovir line per destination.

What is Prevymis used for, and what is its indication?

Prevymis is used to prevent cytomegalovirus infection and disease in transplant recipients. The US label lists CMV-seropositive recipients of an allogeneic haematopoietic stem cell transplant, and high-risk (donor positive, recipient negative) kidney transplant recipients aged 12 years and older weighing at least 40 kg. The UK emc and EMA pages list both uses, with HSCT weight limits that differ between the UK tablet, the UK concentrate and the US label. It is prophylaxis, not treatment of established CMV disease.

What is the difference between Prevymis 240 mg and 480 mg tablets?

Both are the same medicine in different strengths. The US label lists a yellow 240 mg tablet and a pink 480 mg tablet. The standard adult dose is 480 mg once daily, or 240 mg once daily with ciclosporin. The UK SmPC we read covers the 240 mg tablet and notes that the 480 mg dose can be given as two 240 mg tablets. Which strength you can import depends on what your destination registers, and we confirm that before quoting.

How is Prevymis stored, and is a package insert available?

The US label gives 20 to 25 °C for tablets, pellets and injection vials, with excursions to 15 to 30 °C. Tablets and pellets stay in the original package, and vials stay in the carton away from light. The UK SmPC shows a 3-year shelf life for tablets and for the unopened vial. We supply the current prescribing information for the line we quote, and the label of your destination governs use.

Which Prevymis form is bought for patients who cannot swallow tablets?

Both the US and UK labels provide alternatives to tablets. The US label lists a single-dose IV vial for patients unable to take oral therapy and oral pellets in 20 mg and 120 mg packets for patients who cannot swallow tablets. The UK tablet SmPC refers to granules in sachet of 20 mg and 120 mg, and the UK concentrate SmPC covers the IV form at 240 mg per 12 mL. Tablets, IV vials and the oral pellets or granules are separate lines, so we quote each against your formulary.

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 2026-11-08.

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.

Letermovir enquiry

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