Ranked API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for sirolimus, filing since 2008. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
29 markets
02 Canada
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for sirolimus, filing since 2013. 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
03 Switzerland
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 35 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
35 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for sirolimus, filing since 2011. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 8 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
8 markets
Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 5 markets.
Last FDA inspection
2023 · VAI
GMP recognised in
5 markets
06 Switzerland
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for sirolimus, filing since 2006. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.
Last FDA inspection
2026 · VAI
GMP recognised in
4 markets
Credentials confirmed against the regulator files on 25 July 2026
Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for sirolimus, filing since 2004. 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 sirolimus, filing since 2016. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for sirolimus, filing since 2003. 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 3 active US DMFs for sirolimus, filing since 2015.
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 sirolimus, filing since 2021. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for sirolimus, filing since 2007.
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 sirolimus, filing since 2013.
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 sirolimus, filing since 2017.
Last FDA inspection
Not established
GMP recognised in
Not established
Holds one active US DMF for sirolimus, filing since 2020.
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 sirolimus, filing since 2025.
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 sirolimus, filing since 2022.
Last FDA inspection
Not established
GMP recognised in
Not established
15 more manufacturers hold filings for sirolimus
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 (4)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (13)
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