Molecules / Valproic Acid

Valproic Acid API manufacturers

CAS 99-66-1 ATC N03AG01 Updated 9 July 2026
9
manufacturers with an active filing 8 of them hold a US DMF or a CEP
$34.05
median export price per kg $25.63 to $44.54 · 40 exporters · 2025
13
shortage records on file across 2 countries
286
finished-dose makers across 37 regulators
Showing 9 of 9 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Harman Finochem

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

Holds one valid CEP for valproic acid, filing since 2025. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
3 markets
How this listing is sourced EDQM certificate database
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02

Sanofi Winthrop Industrie

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

Holds one valid CEP for valproic acid, filing since 2024. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 17 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
17 markets
How this listing is sourced EDQM certificate database
View profile
03

Sci Pharmtech

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

Holds one active US DMF for valproic acid, filing since 2003. 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
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04

Emnar Pharma

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

Holds 2 active US DMFs for valproic acid, filing since 2026. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

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

Pcas

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

Holds one active US DMF for valproic acid, filing since 1985. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Assurgen Pharma

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

Holds one valid CEP for valproic acid, filing since 2024.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
08

Katwijk Chemie

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

Holds one active US DMF for valproic acid, filing since 1986.

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
09

SaVipharm J.S.C

Vietnam
Makes the API

Registered with DAV (Vietnam) for valproic acid. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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6 more manufacturers hold filings for valproic acid

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

Emnar PharmaPcasAssurgen PharmaHebei Chenguang Tongsheng PharmaKatwijk ChemieSaVipharm J.S.C
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Finished-dose makers (62)

Sanofi France Viatris United States Teva Israel Pharmascience Canada Torrent Pharmaceuticals India Abbvie United States Apotex Canada HIKMA ITALIA Italy Hospira United States Quagen Pharmaceuticals United States Synthimed Labs India ANI Pharmaceuticals United States Laboratorios Recalcine Chile Cipla India Delta Pharma Pakistan Eurofarma Laboratorios Brazil Jamp Pharma Canada Laboratorios Arsal S A De C V El Salvador Odan Laboratories Canada PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma United States

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.

Who makes valproic acid?

Ask Fred which manufacturers are on record for valproic acid and what filings they hold.

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Also on this molecule

Price history 4 yrs Shortages 13 Recalls 5 Finished dose 62 Contract mfrs 0

Sold in these combinations

Valproic Acid + Sodium Valproate 2 APIs

Fixed-dose combinations containing valproic acid. Each page leads with the verified API makers of every component.

Export price by year

Year Median Exporters
2025 $34.05 40
2024 $30.51 36
2023 $34.75 36
2022 $33.41 32

US dollars per kilogram, customs export unit values.