Ranked API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 valid CEPs for mesalamine, filing since 1996. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 8 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
8 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for mesalamine, filing since 2015. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2025 · NAI
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 4 valid CEPs for mesalamine, filing since 2010. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
19 markets
04 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 valid CEPs for mesalamine, filing since 2009. 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 one valid CEP for mesalamine, filing since 2024. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
4 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 valid CEPs for mesalamine, filing since 2021. Its 2025 FDA inspection closed as NAI.
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for mesalamine, filing since 1989. Its 2022 FDA inspection closed as VAI.
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 valid CEPs for mesalamine, filing since 1998. 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 valid CEP for mesalamine, filing since 2021. 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 valid CEP for mesalamine, filing since 2006. Its 2023 FDA inspection closed as VAI.
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for mesalamine, filing since 2023. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2019 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for mesalamine, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Its GMP is recognised in 21 markets.
Last FDA inspection
Not established
GMP recognised in
21 markets
Credentials confirmed against the regulator files on 25 July 2026
Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
3 markets
Credentials confirmed against the regulator files on 25 July 2026
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 valid CEP for mesalamine, filing since 2021. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
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 valid CEPs for mesalamine, filing since 2021. 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
Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
20 United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
27 more manufacturers hold filings for mesalamine
The names are listed below. Ask Fred about the filings, inspection history and GMP
certificates on record for each manufacturer.
Chat with Fred, your AI analyst Contract manufacturers (2)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (64)
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.