Ranked API manufacturers
01 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 active US DMFs and one valid CEP for tacrolimus, filing since 2005. 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 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and 2 valid CEPs for tacrolimus, filing since 2005. 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 Slovenia
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and one valid CEP for tacrolimus, filing since 2006. Its GMP is recognised in 13 markets.
Last FDA inspection
Not established
GMP recognised in
13 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for tacrolimus, 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 tacrolimus, filing since 2014. 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
06 Ireland
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for tacrolimus, filing since 2003. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for tacrolimus, filing since 2020. 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 one active US DMF for tacrolimus, filing since 2021. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
09 Israel
Makes the APIFinished dose
Registered with SFDA (Saudi Arabia) for tacrolimus. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 8 markets.
Last FDA inspection
2024 · NAI
GMP recognised in
8 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 tacrolimus, filing since 2024. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
11 South Korea
Makes the API
Holds 2 active US DMFs for tacrolimus, filing since 2016. 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 tacrolimus, filing since 2005. Its 2024 FDA inspection closed as VAI.
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
13 China
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for tacrolimus, filing since 2016. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2023 · VAI
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for tacrolimus, filing since 2008. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
Holds one active US DMF for tacrolimus, filing since 2013. 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 tacrolimus, filing since 2023.
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 tacrolimus, filing since 2024.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for tacrolimus, filing since 2024.
Last FDA inspection
Not established
GMP recognised in
Not established
19 Japan
Makes the APIFinished dose
Registered with SFDA (Saudi Arabia) for tacrolimus. Its GMP is recognised in 11 markets.
Last FDA inspection
Not established
GMP recognised in
11 markets
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 tacrolimus. 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 22 more manufacturers hold filings for tacrolimus
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 (6)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (50)
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.