Ranked API manufacturers
01 United States
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for ciclosporin, filing since 1998. Its 2026 FDA inspection closed as NAI, and its GMP is recognised in 50 markets.
Last FDA inspection
2026 · NAI
GMP recognised in
50 markets
02 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for ciclosporin, filing since 2010. 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
03 Canada
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for ciclosporin, filing since 1999. 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 ciclosporin, filing since 2014. Its 2016 FDA inspection closed as VAI.
Last FDA inspection
2016 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for ciclosporin, filing since 2019. 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
06 South Korea
Makes the API
Holds 2 active US DMFs for ciclosporin, filing since 1996. 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 ciclosporin, filing since 2025. Its 2026 FDA inspection closed as VAI.
Last FDA inspection
2026 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for ciclosporin, filing since 1998. 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 ciclosporin, filing since 1998.
Last FDA inspection
Not established
GMP recognised in
Not established
10 Czech Republic
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Last FDA inspection
Not established
GMP recognised in
Not established
11 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for ciclosporin. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 8 more manufacturers hold filings for ciclosporin
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 (5)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (35)
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