Molecules / Eslicarbazepine

Eslicarbazepine API manufacturers

CAS 236395-14-5 Updated 9 July 2026
17
manufacturers with an active filing 17 of them hold a US DMF or a CEP
132
finished-dose makers across 15 regulators
Showing 17 of 17 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Dr. Reddy's Laboratories

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

Holds one active US DMF for eslicarbazepine, filing since 2017. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 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
02

Lupin

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

Holds one active US DMF for eslicarbazepine, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

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

Alkem Laboratories

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

Holds one active US DMF for eslicarbazepine, filing since 2025. Its GMP is recognised in 21 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
21 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

BIAL - Portela & Ca

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

Holds one active US DMF for eslicarbazepine, filing since 2012. Its GMP is recognised in 15 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
15 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

MSN Laboratories

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

Holds one active US DMF for eslicarbazepine, filing since 2018. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
4 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Ami Lifesciences

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

Holds one active US DMF for eslicarbazepine, filing since 2023. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Cohance Lifesciences

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

Holds 2 active US DMFs for eslicarbazepine, filing since 2018. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Delmar Chemicals

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

Holds 2 active US DMFs for eslicarbazepine, filing since 2017. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Apitoria Pharma

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

Holds one active US DMF for eslicarbazepine, filing since 2020. 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
11
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for eslicarbazepine, filing since 2023. Its 2024 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Dasami Lab

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

Holds 4 active US DMFs for eslicarbazepine, filing since 2017. Its 2025 FDA inspection closed as VAI.

US DMF
4 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

Arene Life Sciences

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

Holds one active US DMF for eslicarbazepine, filing since 2024. Its 2024 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Jubilant Biosys

India
Makes the API

Holds 2 active US DMFs for eslicarbazepine, filing since 2013. 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
15

CTX Lifesciences

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

Holds one active US DMF for eslicarbazepine, filing since 2016. Its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
17
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for eslicarbazepine, 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

14 more manufacturers hold filings for eslicarbazepine

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

BIAL - Portela & CaMSN LaboratoriesAmi LifesciencesCohance LifesciencesDelmar ChemicalsApitoria PharmaShanghai Pharma Group Changzhou Kony PharmaceuticalChunghwa Chemical Synthesis & BiotechDasami LabArene Life SciencesJubilant BiosysCTX LifesciencesInner Mongolia Jingdong PharmaceuticalHubei Gedian humanwell Pharmaceutical
Open the full list with a free account

Contract manufacturers (4)

Torrent Pharmaceuticals India CTX Lifesciences India Ami Lifesciences India Amoli Organics Umedica Laboratories India

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

Finished-dose makers (13)

Torrent Pharmaceuticals India Apotex Canada Sumitomo Pharma Japan Zentiva, k.s Czech Republic Jubilant Generics India Laboratorios Cinfa S A Spain Laboratorios Normon Spain Aristo Pharma Germany Laboratorios Alter Spain Medochemie Cyprus Viatris United States MEDITOP Pharmaceutical Hungary Laboratorio Stada S.L Spain

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

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Also on this molecule

Finished dose 13 Contract mfrs 4

By country

India 19 China 6