Molecules / Brexpiprazole

Brexpiprazole API manufacturers

CAS 913611-97-9 ATC N05AX16 Updated 9 July 2026
20
manufacturers with an active filing 20 of them hold a US DMF or a CEP
78
finished-dose makers across 32 regulators
Showing 20 of 20 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Apotex

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

Holds one active US DMF for brexpiprazole, filing since 2019. 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
02

Lupin

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

Holds one active US DMF for brexpiprazole, filing since 2019. 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

Macleods Pharmaceuticals

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

Holds one active US DMF for brexpiprazole, filing since 2019. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
29 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Alembic Pharmaceuticals

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

Holds one active US DMF for brexpiprazole, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
18 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Honour Lab

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

Holds one active US DMF for brexpiprazole, filing since 2018. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Cipla

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

Holds one active US DMF for brexpiprazole, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

MSN Laboratories

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

Holds one active US DMF for brexpiprazole, filing since 2017. 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
08

Zydus Lifesciences

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

Holds one active US DMF for brexpiprazole, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

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

Raks Pharma

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

Holds one active US DMF for brexpiprazole, filing since 2018. Its 2025 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Biophore India Pharmaceuticals

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

Holds one active US DMF for brexpiprazole, filing since 2019. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Zaklady Farmaceutyczne Polpharma

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

Holds one active US DMF for brexpiprazole, filing since 2017. 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
12

Apitoria Pharma

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

Holds one active US DMF for brexpiprazole, filing since 2019. 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
13

Morepen Laboratories

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

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

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · NAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
14

ScinoPharm Taiwan

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

Holds one active US DMF for brexpiprazole, filing since 2018. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Topharman Shandong

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

Holds one active US DMF for brexpiprazole, filing since 2022. 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
17

Jubilant Biosys

India
Makes the API

Holds 2 active US DMFs for brexpiprazole, filing since 2018. 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
18

Beijing Hope Pharmaceutical

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

Holds one active US DMF for brexpiprazole, filing since 2024.

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
20

Zhejiang Huahai Pharmaceutical

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

Holds one active US DMF for brexpiprazole, filing since 2019. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 1 market.

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

17 more manufacturers hold filings for brexpiprazole

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

Alembic PharmaceuticalsHonour LabCiplaMSN LaboratoriesZydus LifesciencesRaks PharmaBiophore India PharmaceuticalsZaklady Farmaceutyczne PolpharmaApitoria PharmaMorepen LaboratoriesScinoPharm TaiwanTopharman ShandongZhejiang Guobang PharmaceuticalJubilant BiosysBeijing Hope PharmaceuticalHuadong Medicine (Xi'An) Bodyguard PharmaceuticalZhejiang Huahai Pharmaceutical
Open the full list with a free account

Contract manufacturers (3)

CTX Lifesciences India Kimia Biosciences India Polpharma Group Poland

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

Finished-dose makers (18)

Otsuka Pharmaceutical India India Ajanta Pharma India Amneal United States Teva Israel Torrent Pharmaceuticals India H. Lundbeck A/S Denmark Sandoz Switzerland Siegfried Switzerland Alkem Laboratories India Elaiapharm France Marcyrl Pharmaceutical Industries Egypt Laboratorio Chile Chile Pharma Apex Saudi Arabia Công ty TNHH DRP Inter Vietnam Aja Pharmaceutical Industries Saudi Arabia Chartwell RX United States Roemmers Argentina Tabuk Pharmaceutical Manufacturing Saudi Arabia

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

Recalls 1 Finished dose 18 Contract mfrs 3

By country

India 22 China 10