Valcyte (valganciclovir) is an oral prodrug of ganciclovir for CMV retinitis in adults with AIDS and for preventing CMV disease after solid-organ transplant, supplied as 450 mg tablets and a 50 mg/mL oral solution, with a boxed warning in the US label.
M Care Exports supplies Valcyte (valganciclovir) and Indian-made valganciclovir 450 mg tablets to transplant centres, hospital pharmacies, importers and tender desks in the GCC, Africa and the UK. If you are looking for Valcyte 450 mg, send the destination, the presentation and the quantity, and we quote per destination.
Valganciclovir exporter and bulk supplier from India.
"We need a partner for Valcyte 450 mg" is a typical enquiry from a transplant pharmacy or an importer serving one. M Care is a merchant-exporter: we supply originator or regulator-registered brands and Indian-made lines, and we confirm which one your destination's registration route accepts before quoting. Our roster lists Valcyte 450 mg tablets alongside Indian-made brands such as Valcip, Valgan and Valgacel. We do not state that any Indian-made line is registered in a given destination. The US label (Valcyte distributed by H2-Pharma, LLC, licensed by Cheplapharm Arzneimittel GmbH) covers tablets and a powder for oral solution. On emc, the UK has a separate SmPC for each, the 450 mg tablets and the 50 mg/mL powder for oral solution, both listing Neon Healthcare Ltd. The quote depends on the presentation, the pack, the quantity, the destination's registration route and Incoterms. Neither the US label nor the UK SmPCs require refrigeration for the unopened product, though the US label stores it at 20 to 25 °C with excursions permitted to 15 to 30 °C, so plan the freight lane around that range. The antiviral letermovir (Prevymis) is a separate product with a different target and indication, and we quote it separately.
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.
Deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor; a prodrug (L-valyl ester) of ganciclovir, sourced and documented for export.
Valganciclovir is an oral prodrug (L-valyl ester) of ganciclovir, a synthetic analogue of 2'-deoxyguanosine that inhibits replication of cytomegalovirus (CMV). The US label (Valcyte, revised December 2025) lists adults with CMV retinitis in AIDS, and prevention of CMV disease in high-risk (donor positive, recipient negative) kidney, heart and kidney-pancreas transplant patients. For children it lists prevention in kidney transplant patients aged 4 months to 16 years and heart transplant patients aged 1 month to 16 years. The UK tablet SmPC (text revised 28 April 2026; first authorised 25 April 2002) lists induction and maintenance treatment of CMV retinitis in adults with AIDS, and prevention of CMV disease in CMV-negative adults and children (birth to 18 years) who received a solid organ transplant from a CMV-positive donor. The US label covers 450 mg tablets and a 50 mg/mL powder for oral solution; the UK lists them in two SmPCs on emc. The US label carries a boxed warning: haematologic toxicity, impairment of fertility, fetal toxicity, mutagenesis and carcinogenesis. The WHO Model List (2023) lists valganciclovir 450 mg tablets on the core list, and the powder for oral solution 50 mg/mL with the tablet on the complementary list, each marked "For the treatment of cytomegalovirus retinitis (CMVr)."
Active ingredient
Valganciclovir hydrochloride. Deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor; a prodrug (L-valyl ester) of ganciclovir.
Forms and strengths
450 mg film-coated tablet (bottle of 60); 50 mg/mL powder for oral solution (approximately 100 mL after constitution).
Indications
Valganciclovir is an oral prodrug of ganciclovir indicated for CMV retinitis in adults with AIDS and for prevention of CMV disease in solid-organ transplant recipients, supplied by M Care Exports as 450 mg tablets and 50 mg/mL oral solution to licensed buyers.
Administration
Oral. Film-coated tablet; powder for oral solution.
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 are transplant centres, hospital pharmacists, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Valcyte 450 mg for a transplant unit" or "We need a partner for valganciclovir tablets 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. M Care supplies both originator or regulator-registered brands and Indian-made lines. The registration status of a product, or whether a named-patient or unlicensed import is needed, depends on the destination regulator, and M Care Exports confirms the route per enquiry.
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 valganciclovir.
Check the indication first, because the duration changes. For CMV retinitis the US label and UK SmPC give induction of 900 mg (two 450 mg tablets) twice daily for 21 days, then 900 mg once daily as maintenance. For prevention, both give 900 mg once daily starting within 10 days of transplant. The US label runs this to Day 100 for heart and kidney-pancreas recipients and Day 200 for kidney recipients. The UK SmPC gives Day 100 for kidney transplant, which may be extended to Day 200, and Day 100 for other solid organs. Doses are renally adjusted by creatinine clearance, for example 450 mg twice daily for induction at 40 to 59 mL/min. Take with food. Do not break or crush tablets, and avoid skin or mucous membrane contact with broken tablets. The US label says to handle and dispose of the product under guidelines for antineoplastic drugs. The UK tablet SmPC says Valcyte cannot be substituted for ganciclovir capsules on a one-to-one basis, with a risk of overdose. The UK SmPC says tablets should not be used in patients on haemodialysis. Reconstituted solution is stored refrigerated at 2 to 8 °C for no longer than 49 days.
The documentation pack a regulator actually asks for.
Valcyte tablets and the unopened powder need no refrigeration. The US label stores tablets and dry powder at 20 to 25 °C, with excursions to 15 to 30 °C. The UK SmPCs state that the tablets and the powder need no special storage conditions, with a shelf life of 3 years for each. Once the powder is reconstituted, the US label has it prepared by the pharmacist before dispensing and stored refrigerated at 2 to 8 °C for no longer than 49 days, so oral solution orders should be planned around that window. The US pack is a bottle of 60 tablets, or a glass bottle of powder giving approximately 100 mL of solution after constitution, supplied with a bottle adapter and two oral dispensers. The UK tablet pack is a bottle of 60 with a child-resistant closure. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator asks for it. We state the source and status of each line before quoting. M Care Exports is a merchant-exporter, not a manufacturer, and it makes no WHO-GMP or WHO prequalification claim for itself.
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 valganciclovir.
Letermovir (Prevymis)
CMV DNA terminase complex inhibitor · CMV prophylaxis in transplant recipients
Valaciclovir (Valtrex)
Aciclovir prodrug · herpes simplex and herpes zoster
Aciclovir (Zovirax)
Nucleoside analogue · herpes simplex, herpes zoster
All antivirals & hiv
The full category listing for procurement desks.
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 valganciclovir.
- 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.
Valganciclovir supply, the specific questions.
What is Valcyte 450 mg and what is it used for?
Valcyte 450 mg is a film-coated tablet of valganciclovir, an oral prodrug of ganciclovir. The UK SmPC lists induction and maintenance treatment of CMV retinitis in adults with AIDS, and prevention of CMV disease in CMV-negative adults and children (birth to 18 years) who received a solid organ transplant from a CMV-positive donor. The US label lists CMV retinitis in AIDS and prevention in high-risk kidney, heart and kidney-pancreas transplant patients, with age limits for children. A label's wording governs use in each destination, and M Care Exports quotes per destination.
Is there a Valcyte price, and what sets the cost for an importer?
We do not publish a figure, because the landed price depends on several things. These are whether you want the originator Valcyte or an Indian-made line, the tablet or oral solution presentation, the pack and quantity, the destination's registration route, and the Incoterms. Neither the US label nor the UK SmPCs require refrigeration for the unopened product, so a 2 to 8 °C cold chain is not a cost driver for unopened stock. M Care Exports quotes per destination once we have the destination, presentation and volume.
Is there a Valcyte generic?
In the UK, the emc lists valganciclovir 450 mg film-coated tablets from Amarox Limited, Aurobindo Pharma (Milpharm Ltd) and Cipla EU Ltd alongside Valcyte from Neon Healthcare Ltd. In the US, DailyMed carries valganciclovir tablet and for-solution labels under generic names alongside the Valcyte label. For the EU, check the national register of the destination. M Care also supplies Indian-made lines such as Valcip, Valgan and Valgacel, and we do not say they are registered in any destination.
What is the Valcyte dose?
For CMV retinitis the US label and UK SmPC give 900 mg (two 450 mg tablets) twice daily for 21 days as induction, then 900 mg once daily as maintenance. For prevention after transplant both give 900 mg once daily from within 10 days of transplant, to Day 100 or Day 200 depending on the organ and the label. Doses are reduced by creatinine clearance, and tablets should be taken with food. Paediatric dosing uses a formula based on body surface area and creatinine clearance. Your prescriber follows the label for the destination.
What are the Valcyte side effects and warnings?
The US label carries a boxed warning for haematologic toxicity, impairment of fertility, fetal toxicity, mutagenesis and carcinogenesis. The UK SmPC says not to start therapy if the absolute neutrophil count is below 500 cells/µl, platelets below 25,000/µl or haemoglobin below 8 g/dl, and to monitor blood counts regularly. Read the full label for the destination before prescribing.
How does Valcyte compare with letermovir (Prevymis)?
On label facts only. Valganciclovir is an oral prodrug of ganciclovir, given as tablets or oral solution, for CMV retinitis treatment in adults with AIDS and for preventing CMV disease after solid-organ transplant. The US Prevymis label describes letermovir as a CMV DNA terminase complex inhibitor, given as tablets, oral pellets or IV, for prophylaxis in CMV-seropositive allogeneic stem cell transplant recipients and high-risk kidney transplant recipients. Which suits a patient is for the clinician. See our letermovir page.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-09.
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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