Molecules / Carbamazepine

Carbamazepine API manufacturers

CAS 298-46-4 ATC N03AF01 Updated 9 July 2026
10
manufacturers with an active filing 10 of them hold a US DMF or a CEP
$58.00
median export price per kg $43.72 to $75.37 · 37 exporters · 2025
62
shortage records on file across 6 countries
587
finished-dose makers across 52 regulators
Showing 10 of 10 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Amoli Organics

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

Holds one active US DMF for carbamazepine, filing since 2009. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Siegfried Evionnaz

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

Holds 2 active US DMFs and one valid CEP for carbamazepine, filing since 1981. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
03

Zaklady Farmaceutyczne Polpharma

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

Holds one active US DMF for carbamazepine, filing since 2012. Its 2018 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2018 · VAI
GMP recognised in
9 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Dasami Lab

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

Holds 2 active US DMFs for carbamazepine, filing since 2021. 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
05

Zhejiang Raybow Pharmaceutical

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

Holds one valid CEP for carbamazepine, filing since 2018. Its 2024 FDA inspection closed as NAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
06

CTX Lifesciences

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

Holds one active US DMF and one valid CEP for carbamazepine, filing since 2020. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
07
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for carbamazepine, filing since 1986. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Arevipharma

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

Holds one valid CEP for carbamazepine, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
09

Jubilant Biosys

India
Makes the API

Holds 2 active US DMFs for carbamazepine, filing since 1999. 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
10

Bajaj Healthcare

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

Holds one valid CEP for carbamazepine, filing since 2025. Its GMP is recognised in 2 markets.

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

7 more manufacturers hold filings for carbamazepine

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

Dasami LabZhejiang Raybow PharmaceuticalCTX LifesciencesF.I.S. – Fabbrica Italiana SinteticiArevipharmaJubilant BiosysBajaj Healthcare
Open the full list with a free account

Contract manufacturers (6)

CTX Lifesciences India Bajaj Healthcare India zhejiang jiuzhou pharmaceutical China Amoli Organics Umedica Laboratories India Polpharma Group Poland Surya Life Sciences India

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

Finished-dose makers (55)

Torrent Pharmaceuticals India Apotex Canada Ajanta Pharma India Alembic Pharmaceuticals India Novartis Switzerland Taro Pharmaceuticals Israel Epic Pharma United States Teva Israel Viatris United States Zentiva, k.s Czech Republic Bostal United States Synthimed Labs India Delpharm Huningue Sas France Sandoz Switzerland ANI Pharmaceuticals United States Rhr Medicare India Inventia Healthcare India Sanofi France Medicamen Biotech India Novartis Farmacéutica, S. A 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
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 62 Recalls 8 Finished dose 55 Contract mfrs 6

By country

India 9

Export price by year

Year Median Exporters
2026 YTD $54.72 13
2025 $58.00 37
2024 $70.00 31
2023 $78.98 18

US dollars per kilogram, customs export unit values.