Ranked API manufacturers
01 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for roflumilast, filing since 2021. Its 2026 FDA inspection closed as NAI, and its GMP is recognised in 20 markets.
Last FDA inspection
2026 · NAI
GMP recognised in
20 markets
02 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for roflumilast, filing since 2013. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
03 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for roflumilast, filing since 2014. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
6 markets
04 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for roflumilast, filing since 2014. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for roflumilast, filing since 2024. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for roflumilast, filing since 2018. 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 roflumilast, filing since 2012. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Last FDA inspection
2022 · NAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for roflumilast, filing since 2014. 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 roflumilast, filing since 2014. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
10 Switzerland
Makes the API
Registered with SFDA (Saudi Arabia) for roflumilast. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Last FDA inspection
2023 · NAI
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile Holds one active US DMF for roflumilast, filing since 2014.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for roflumilast, filing since 2014.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for roflumilast, filing since 2023.
Last FDA inspection
Not established
GMP recognised in
Not established
14 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for roflumilast, filing since 2017.
Last FDA inspection
Not established
GMP recognised in
Not established
Registered with SFDA (Saudi Arabia) for roflumilast. Its 2024 FDA inspection closed as VAI.
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 16 Switzerland
Makes the API
Registered with SFDA (Saudi Arabia) for roflumilast.
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 13 more manufacturers hold filings for roflumilast
The names are listed below. The filings, inspection history and GMP certificates behind
each one are available with a free account.
Open the full list with a free account Contract manufacturers (1)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (10)
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