Medicine
Valganciclovir 50 mg/mL powder for oral solution
Valganciclovir 50 mg/mL powder for oral solution is a generic prescription medicine for oral use, made by 14 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store constituted solution under refrigeration at 2°C to 8°C (36°F to 46°F)…
Key facts
- Active ingredient (INN)
- Valganciclovir
- Brand
- Sold under the generic name
- Strength
- 50 mg/mL
- Dosage form
- Powder for oral solution
- Route
- Oral
- Packs
- 1 bottle, 100 mL, 1 pouch and 12 more
- Manufacturers
- Alembic PharmaceuticalsIndiaairis PHARMAIndiaAjanta PharmaIndiaAurobindo PharmaIndiaCamber PharmaceuticalsIndiaGranules IndiaIndiaMicro LabsIndiaNovadoz PharmaceuticalsIndiaActavis PharmaAmerican Health Packaging
- Origin register
- US FDA, United States
- Storage
- Store constituted solution under refrigeration at 2°C to 8°C (36°F to 46°F) for no longer than 49 days. Do not freeze. Store dry powder at 20°C to 25°C (68°F to 77°F), excursions are permitted to 15°C to 30°C (59°F to 86°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J05AB14 Valganciclovir
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 August 2016
- Identifiers
- RxCUI 863559DailyMed set ID 614ff447-7e5f-4ea6-ba85-ec1f6497b360, 2e8a4d62-2098-4ffe-a154-e45cfdfe6c4c, 39452b74-161d-4525-a0f7-fe486f001513 +12NDC 72205-019, 72603-174, 70010-051 +12Application ANDA210169, ANDA211475, ANDA213306 +6
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 100 mL in 1 bottle | 46708-754-31 | Alembic PharmaceuticalsIndia | 28 October 2026 |
| 1 bottle in 1 carton / 100 mL in 1 bottle | 62332-754-31 | Alembic PharmaceuticalsIndia | 28 October 2026 |
| 100 mL in 1 bottle, dispensing | 71151-003-01 | airis PHARMAIndia | 28 February 2022 |
| 1 pouch in 1 carton / 1 bottle in 1 pouch / 100 mL in 1 bottle | 27241-159-19 | Ajanta PharmaIndia | 13 January 2020 |
| 1 bottle, glass in 1 carton / 100 mL in 1 bottle, glass | 59651-444-01 | Aurobindo PharmaIndia | 17 November 2022 |
| 1 bottle, glass in 1 carton / 100 mL in 1 bottle, glass | 31722-837-10 | Camber PharmaceuticalsIndia | 4 October 2022 |
| 100 mL in 1 bottle | 70010-051-40 | Granules IndiaIndia | 1 July 2021 |
| 1 bottle in 1 carton / 100 mL in 1 bottle | 42571-477-47 | Micro LabsIndia | 1 June 2026 |
| 1 bottle in 1 carton / 100 mL in 1 bottle | 72205-019-01 | Novadoz PharmaceuticalsIndia | 14 September 2022 |
| 100 mL in 1 bottle, glass | 0591-2579-20 | Actavis Pharma | 26 August 2016 |
| 1 bottle in 1 carton / 100 mL in 1 bottle | 71921-210-12 | Florida Pharmaceutical Products | 1 July 2023 |
| 100 mL in 1 bottle | 70069-810-01 | Somerset Therapeutics | 15 January 2022 |
| 1 bottle, glass in 1 carton / 100 mL in 1 bottle, glass | 60687-765-13 | American Health Packaging | 20 August 2023 |
| 100 mL in 1 bottle | 42291-972-01 | AvKARE | 17 October 2023 |
| 1 bottle, glass in 1 carton / 100 mL in 1 bottle, glass | 72603-174-01 | NorthStar RxLLC | 8 April 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 29 March 2001 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Valganciclovir 50 mg/mL powder for oral solution.
Other strengths and forms of Valganciclovir
Clinical summary
Valganciclovir is a cytomegalovirus nucleoside analog DNA polymerase inhibitor indicated for adult Patients, among other approved uses. It is available as powder for oral solution and tablets. MedsAcross supplies Valganciclovir for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about ValganciclovirFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Valcyte prescribing information (H2-Pharma) · U.S. National Library of Medicine, DailyMed
Need Valganciclovir 50 mg/mL powder for oral solution for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.