Molecules / Amisulpride

Amisulpride API manufacturers

CAS 71675-85-9 ATC N05AL05 Updated 9 July 2026
14
manufacturers with an active filing 9 of them hold a US DMF or a CEP
$169.50
median export price per kg $134.68 to $208.50 · 23 exporters · 2025
35
shortage records on file across 5 countries
217
finished-dose makers across 32 regulators
Showing 14 of 14 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

02

COSMA

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

Holds 2 active US DMFs and one valid CEP for amisulpride, filing since 2017. Its 2022 FDA inspection closed as VAI.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
03

Sanofi Winthrop Industrie

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

Holds one valid CEP for amisulpride, filing since 2025. 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
04

Symed Labs

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

Holds 2 valid CEPs for amisulpride, filing since 2019. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
05

CTX Lifesciences

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

Holds one valid CEP for amisulpride, filing since 2023. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
06

Erregierre

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

Holds one valid CEP for amisulpride, filing since 2017. 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
07

Hubei Haosun Pharmaceutical

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

Holds one valid CEP for amisulpride, filing since 2020. Its GMP is recognised in 1 market.

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

Apitoria Pharma

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

Holds one valid CEP for amisulpride, 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
09

Aurobindo Pharma Limited, Unit I

India
Makes the API

Registered with SFDA (Saudi Arabia) for amisulpride.

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
10

Zhejiang Huahai Pharmaceutical

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

Holds one valid CEP for amisulpride, filing since 2023. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · OAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
11

Agimexpharm Pharmaceutical

Vietnam
Makes the API

Registered with DAV (Vietnam) for amisulpride. 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
View profile

Registered with DAV (Vietnam) for amisulpride. 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
View profile
13

Công ty cổ phần Dược phẩm An Thiên

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for amisulpride. 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
View profile
14

Registered with DAV (Vietnam) for amisulpride. 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
View profile

Contract manufacturers (3)

Erregierre Italy Icrom Italy Shenzhen Haorui Industrial Dev China

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

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By country

Export price by year

Year Median Exporters
2025 $169.50 23
2024 $184.50 15
2023 $235.00 16
2022 $252.55 9

US dollars per kilogram, customs export unit values.