Ranked API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and 2 valid CEPs for mycophenolate mofetil, filing since 2003. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for mycophenolate mofetil, filing since 2011. Its GMP is recognised in 13 markets.
Last FDA inspection
Not established
GMP recognised in
13 markets
03 Canada
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 valid CEPs for mycophenolate mofetil, filing since 2018. 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 and one valid CEP for mycophenolate mofetil, filing since 2024. 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 mycophenolate mofetil, filing since 2007. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
6 markets
06 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 valid CEPs for mycophenolate mofetil, filing since 2024. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for mycophenolate mofetil, filing since 2024. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2026 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for mycophenolate mofetil, filing since 2010. Its 2024 FDA inspection closed as VAI.
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
09 China
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for mycophenolate mofetil, filing since 2019. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for mycophenolate mofetil, filing since 2008. 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 mycophenolate mofetil, filing since 2021. 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 valid CEP for mycophenolate mofetil, filing since 2021.
Last FDA inspection
Not established
GMP recognised in
Not established
13 Czech Republic
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for mycophenolate mofetil, filing since 2025.
Last FDA inspection
Not established
GMP recognised in
Not established
10 more manufacturers hold filings for mycophenolate mofetil
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 Finished-dose makers (29)
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.