Ranked API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and 2 valid CEPs for tretinoin, filing since 1988. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for tretinoin, filing since 1978. 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 active US DMF for tretinoin, filing since 2013. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2024 · NAI
GMP recognised in
2 markets
Registered with SFDA (Saudi Arabia) for tretinoin. Its 2009 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.
Last FDA inspection
2009 · VAI
GMP recognised in
19 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 05 United States
Makes the API
Holds one active US DMF for tretinoin, filing since 2009.
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 tretinoin, filing since 2013.
Last FDA inspection
Not established
GMP recognised in
Not established
07 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for tretinoin. Its GMP is recognised in 3 markets.
Last FDA inspection
Not established
GMP recognised in
3 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 08 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for tretinoin. 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 5 more manufacturers hold filings for tretinoin
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 (4)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (63)
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.