Molecules / Valganciclovir

Valganciclovir API manufacturers

CAS 175865-60-8 ATC J05AB14 · Nucleoside antivirals Updated 9 July 2026
18
manufacturers with an active filing 15 of them hold a US DMF or a CEP
$1582.03
median export price per kg $1305.08 to $2854.82 · 13 exporters · 2024
25
shortage records on file across 6 countries
282
finished-dose makers across 40 regulators
Showing 18 of 18 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Olon

Italy
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 4 active US DMFs and one valid CEP for valganciclovir, filing since 2009. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
4 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
02

Ajanta Pharma

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for valganciclovir, filing since 2021. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 15 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
15 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Dr. Reddy's Laboratories

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for valganciclovir, filing since 2011. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Maithri Drugs

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs and one valid CEP for valganciclovir, filing since 2020. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
06

Hetero

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for valganciclovir, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Pharmathen

Greece
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for valganciclovir, filing since 2017. Its GMP is recognised in 18 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
18 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Cipla

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for valganciclovir, filing since 2014. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Apitoria Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for valganciclovir, filing since 2012. Its 2025 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Matrix Pharmacorp

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for valganciclovir, filing since 2009. Its 2025 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Dishman Carbogen Amcis

India
Makes the API

Registered with SFDA (Saudi Arabia) for valganciclovir. Its 2025 FDA inspection closed as NAI.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
14

Corden Pharma

United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for valganciclovir, filing since 2015.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Ind-Swift Laboratories

India
Makes the API

Registered with SFDA (Saudi Arabia) for valganciclovir. Its GMP is recognised in 3 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
3 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
16
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for valganciclovir, filing since 2025. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · OAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
17

Aurobindo Pharma

India
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for valganciclovir. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 21 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · OAI
GMP recognised in
21 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
18
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for valganciclovir, filing since 2012. Its 2024 FDA inspection closed as OAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · OAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile

Contract manufacturers (3)

Contract manufacturers make to order rather than holding their own filing for this molecule.

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators
Price band
Customs export unit values for 2024. These are export values rather than contract prices for regulated-market grade material, which are higher.

Map valganciclovir for your markets

Tell us which markets you need to file in. These suppliers come back tiered for those markets, with the price corridor and an RFI sheet.

Start for free
No sales call.

Export price by year

Year Median Exporters
2024 $1582.03 13
2023 $2033.12 17
2022 $1868.10 12

US dollars per kilogram, customs export unit values.