Molecules / Articaine

Articaine API manufacturers

CAS 23964-58-1 ATC N01BB08 Updated 9 July 2026
8
manufacturers with an active filing 7 of them hold a US DMF or a CEP
$212.90
median export price per kg $210.41 to $215.84 · 6 exporters · 2024
7
shortage records on file across 2 countries
165
finished-dose makers across 24 regulators
Showing 8 of 8 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Moehs

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

Holds one active US DMF and one valid CEP for articaine, filing since 2011. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
02

Siegfried

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

Holds one active US DMF and one valid CEP for articaine, filing since 2002. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
03

Cohance Lifesciences

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

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

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
04

Pcas

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

Holds one active US DMF for articaine, filing since 2004. 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
05

Orgapharm Sas

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

Holds one active US DMF for articaine, filing since 2003. Its 2022 FDA inspection closed as VAI.

US DMF
1 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
06

Sci Pharmtech

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

Holds one active US DMF for articaine, filing since 1996. 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
07

Zentiva Ks

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

Holds one active US DMF for articaine, filing since 2007.

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
08

Benechim

Belgium
Makes the API

Registered with SFDA (Saudi Arabia) for articaine. Its 2025 FDA inspection closed as VAI.

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

5 more manufacturers hold filings for articaine

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

Open the full list with a free account

Contract manufacturers (5)

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.

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Sold in these combinations

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

Export price by year

Year Median Exporters
2024 $212.90 6
2022 $196.18 5

US dollars per kilogram, customs export unit values.