Molecules / Valaciclovir

Valaciclovir API manufacturers

CAS 124832-26-4 ATC J05AB11 · Nucleoside antivirals Updated 9 July 2026
17
manufacturers with an active filing 15 of them hold a US DMF or a CEP
$175.00
median export price per kg $165.00 to $240.00 · 15 exporters · 2025
38
shortage records on file across 7 countries
355
finished-dose makers across 46 regulators
Showing 17 of 17 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Hetero

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

Holds 2 active US DMFs for valaciclovir, filing since 2007. 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
02

Apotex

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

Holds one active US DMF for valaciclovir, filing since 2008. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Flamma

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

Holds one active US DMF and one valid CEP for valaciclovir, filing since 2004. Its 2023 FDA inspection closed as VAI.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
04

Piramal Pharma

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

Holds one active US DMF for valaciclovir, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

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

Cipla

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

Holds one active US DMF for valaciclovir, filing since 2003. 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
06

Zydus Lifesciences

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

Holds one active US DMF for valaciclovir, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

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

Atul Bioscience

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

Holds one active US DMF and one valid CEP for valaciclovir, filing since 2025. Its GMP is recognised in 1 market.

US DMF
1 active
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
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 one active US DMF and one valid CEP for valaciclovir, filing since 2008. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Jubilant Biosys

India
Makes the API

Holds 2 active US DMFs for valaciclovir, filing since 2011. Its 2022 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Matrix Pharmacorp

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

Holds one active US DMF for valaciclovir, filing since 2004. Its 2025 FDA inspection closed as VAI.

US DMF
1 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
15

Hikal

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

Holds one active US DMF and one valid CEP for valaciclovir, filing since 2016. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · OAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
16

Mylan Laboratories Ltd. (Unit-7)

India
Makes the API

Registered with SFDA (Saudi Arabia) for valaciclovir.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
17

Tianish Laboratories

India
Makes the API

Registered with SFDA (Saudi Arabia) for valaciclovir.

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

14 more manufacturers hold filings for valaciclovir

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

Piramal PharmaCiplaZydus LifesciencesAtul BioscienceAurore Life SciencesYichang Tianren PharmaceuticalApitoria PharmaShanghai Pharma Group Changzhou Kony PharmaceuticalZhejiang Charioteer PharmaceuticalJubilant BiosysMatrix PharmacorpHikalMylan Laboratories Ltd. (Unit-7)Tianish Laboratories
Open the full list with a free account

Contract manufacturers (2)

Zhejiang Charioteer Pharmaceutical China Spc Lifesciences India

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

Finished-dose makers (25)

Viatris United States Gsk Vaccines United Kingdom Pharmascience Canada Teva Israel HIKMA ITALIA Italy Time Cap Laboratories United States Sandoz Switzerland GlaxoSmithKline United States AlfaSigma Italy Daiichi Sankyo Europe Germany Eurofarma Laboratorios Brazil Jamp Pharma Canada Laboratoire Riva Canada Glaxo Wellcome S/A Spain Orion Finland Oxford Laboratories India Farmak Czech Republic Towa Pharmaceutical Europe, S.L Spain Eg S P A Italy Aplicaciones Médicas Dominican Republic

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 2025. These are export values rather than contract prices for regulated-market grade material, which are higher.

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Also on this molecule

Price history 4 yrs Shortages 38 Recalls 4 Finished dose 25 Contract mfrs 2

By country

India 23 China 6

Export price by year

Year Median Exporters
2025 $175.00 15
2024 $197.18 12
2023 $209.20 23
2022 $229.03 8

US dollars per kilogram, customs export unit values.