Ranked API manufacturers
01 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 paroxetine, filing since 2003. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
25 markets
02 United Kingdom
Makes the API
Its 2026 FDA inspection closed as NAI, and its GMP is recognised in 37 markets.
Last FDA inspection
2026 · NAI
GMP recognised in
37 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 valid CEPs for paroxetine, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
19 markets
04 Canada
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for paroxetine, filing since 2008. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for paroxetine, filing since 2005. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.
Last FDA inspection
2023 · VAI
GMP recognised in
7 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for paroxetine, filing since 2006. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
07 Italy
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for paroxetine, filing since 2020. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 8 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
8 markets
08 Hungary
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for paroxetine, filing since 2022. Its GMP is recognised in 28 markets.
Last FDA inspection
Not established
GMP recognised in
28 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for paroxetine, filing since 2006. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for paroxetine, filing since 2006. Its 2024 FDA inspection closed as NAI.
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and 2 valid CEPs for paroxetine, filing since 2006. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 1 market.
Last FDA inspection
2025 · OAI
GMP recognised in
1 markets
Holds 2 active US DMFs for paroxetine, filing since 2009. Its 2022 FDA inspection closed as VAI.
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for paroxetine, filing since 2023. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for paroxetine, filing since 2024. Its 2024 FDA inspection closed as VAI.
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for paroxetine, filing since 2025. Its 2024 FDA inspection closed as VAI.
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
16 India
Makes the APIFinished dose
Registered with SFDA (Saudi Arabia) for paroxetine. Its GMP is recognised in 7 markets.
Last FDA inspection
Not established
GMP recognised in
7 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for paroxetine, filing since 2014.
Last FDA inspection
Not established
GMP recognised in
Not established
18 United Kingdom
Makes the API
Registered with SFDA (Saudi Arabia) for paroxetine.
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 19 Saudi Arabia
Makes the API
Registered with SFDA (Saudi Arabia) for paroxetine.
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 20 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for paroxetine. Its GMP is recognised in 2 markets.
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 19 more manufacturers hold filings for paroxetine
The names are listed below. Ask Fred about the filings, inspection history and GMP
certificates on record for each manufacturer.
Chat with Fred, your AI analyst Contract manufacturers (3)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (83)
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.