Molecules / Cariprazine

Cariprazine API manufacturers

CAS 839712-12-8 ATC N05AX15 Updated 9 July 2026
13
manufacturers with an active filing 13 of them hold a US DMF or a CEP
50
finished-dose makers across 25 regulators
Showing 13 of 13 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Qilu Pharmaceutical

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

Holds one active US DMF for cariprazine, filing since 2025. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 7 markets.

US DMF
1 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
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02

Lee Pharma

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

Holds one active US DMF for cariprazine, filing since 2023. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 6 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

“Gedeon Richter”

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

Holds one active US DMF for cariprazine, filing since 2012. Its GMP is recognised in 28 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
28 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

MSN Laboratories

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

Holds one active US DMF for cariprazine, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

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

Amoli Organics

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

Holds one active US DMF for cariprazine, filing since 2025. 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
06

Biophore India Pharmaceuticals

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

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

US DMF
2 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
07

Apitoria Pharma

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

Holds one active US DMF for cariprazine, 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
08

Maprimed

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

Holds 2 active US DMFs for cariprazine, filing since 2019. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Optimus Drugs

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

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

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

Mehta Api

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

Holds one active US DMF for cariprazine, filing since 2024. Its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Hoster Labs

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

Holds one active US DMF for cariprazine, 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
12

Hikal

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

Holds one active US DMF for cariprazine, filing since 2026. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · OAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Zhejiang Huahai Pharmaceutical

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

Holds one active US DMF for cariprazine, filing since 2023. 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

10 more manufacturers hold filings for cariprazine

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

MSN LaboratoriesAmoli OrganicsBiophore India PharmaceuticalsApitoria PharmaMaprimedOptimus DrugsMehta ApiHoster LabsHikalZhejiang Huahai Pharmaceutical
Open the full list with a free account

Contract manufacturers (2)

Nifty Labs P India Simson Pharma India

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

Finished-dose makers (9)

Abbvie United States Optimus Drugs India Zydus Lifesciences India Casen Recordati, S.L Spain Alkem Laboratories India BDR Lifesciences India Honour Lab India Sionc Pharmaceuticals India Jazeera Pharmaceutical Industries 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 9 Contract mfrs 2

By country

India 17