Molecules / Aripiprazole

Aripiprazole API manufacturers

CAS 129722-12-9 ATC N05AX12 Updated 9 July 2026
44
manufacturers with an active filing 37 of them hold a US DMF or a CEP
$632.39
median export price per kg $348.02 to $1102.28 · 42 exporters · 2025
163
shortage records on file across 6 countries
825
finished-dose makers across 56 regulators
Showing 20 of 44 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Cadila Pharmaceuticals

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

Holds one active US DMF and one valid CEP for aripiprazole, filing since 2015. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 15 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
15 markets
04

Alembic Pharmaceuticals

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

Holds 2 active US DMFs and 2 valid CEPs for aripiprazole, filing since 2009. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

US DMF
2 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
18 markets
05

Zydus Lifesciences

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

Holds one active US DMF and one valid CEP for aripiprazole, filing since 2006. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
25 markets
06

Neuland Laboratories

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

Holds 4 active US DMFs and one valid CEP for aripiprazole, filing since 2009. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
4 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
07

Cohance Lifesciences

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

Holds 2 active US DMFs and one valid CEP for aripiprazole, filing since 2015. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
08

Olon

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

Holds one active US DMF and one valid CEP for aripiprazole, filing since 2006. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
09

Qilu Pharmaceutical

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

Holds 2 active US DMFs for aripiprazole, filing since 2024. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 7 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
7 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Apotex

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

Holds one active US DMF for aripiprazole, filing since 2006. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Gland Pharma

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

Holds 2 active US DMFs for aripiprazole, filing since 2021. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
19 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Alkem Laboratories

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

Holds one active US DMF and one valid CEP for aripiprazole, filing since 2014. Its GMP is recognised in 21 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
21 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

SMS Pharmaceuticals

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

Holds one active US DMF and one valid CEP for aripiprazole, filing since 2015. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 6 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · OAI
GMP recognised in
6 markets
14

Unichem Laboratories

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

Holds one valid CEP for aripiprazole, filing since 2025. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2026 · VAI
GMP recognised in
13 markets
How this listing is sourced EDQM certificate database
View profile
15

HEC Pharm

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

Holds one active US DMF for aripiprazole, filing since 2016. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
16

Synthon

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

Holds one valid CEP for aripiprazole, filing since 2025. Its GMP is recognised in 14 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
14 markets
How this listing is sourced EDQM certificate database
View profile
17

Zaklady Farmaceutyczne Polpharma

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

Holds 2 active US DMFs for aripiprazole, filing since 2009. Its 2018 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.

US DMF
2 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
18

Erregierre

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

Holds one active US DMF for aripiprazole, filing since 2005. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 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
19

Reyoung Pharmaceuticals

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

Holds one active US DMF for aripiprazole, filing since 2022. Its GMP is recognised in 4 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
4 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
20

Apitoria Pharma

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

Holds 2 active US DMFs and one valid CEP for aripiprazole, filing since 2011. Its 2025 FDA inspection closed as VAI.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

Contract manufacturers (9)

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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Export price by year

Year Median Exporters
2026 YTD $695.80 19
2025 $632.39 42
2024 $665.19 40
2023 $935.84 48

US dollars per kilogram, customs export unit values.